External Manufacturing Resume Samples

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DK
D Kuvalis
Dean
Kuvalis
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Experience Experience
Chicago, IL
Biologics External Manufacturing
Chicago, IL
Huel-Kunze
Chicago, IL
Biologics External Manufacturing
  • Act as primary BEM supply chain contact for internal and external customers for product inquiry, supplier performance, shipments, scheduling, and transactional activities
  • Work effectively with Global Supply Chain and downstream processing sites to ensure timely delivery of customer orders and communication of issues, risks, and opportunities
  • Membership of BMS virtual supplier management team, interfacing with Quality, MS&T, SRM and Procurement to support resolution of any supply risks that may arise
  • Resolve invoice discrepancies or other purchasing price variances
  • Maintain SAP master data and aides in development, implementation, and tracking of supply chain performance metrics
  • Provide input into inventory projections to highlight how forecast trends are driving projection
  • Proactively highlight any potential inventory write off risk
Chicago, IL
Assoc Dir External Manufacturing
Chicago, IL
Grady Inc
Chicago, IL
Assoc Dir External Manufacturing
  • The ExM Snr Ops Mgr is the primary owner and single point of contact for MSDs relationship with the contract manufacturer for all dealings between the two parties. The ExM Senior Ops Mgr serves as the main liaison & gate keeper between MSD and the contract manufacturer for commercial supply and establishes boundaries, ground rules of engagement, and collaboration between the Contract Manufacturer and MSD, informed by the Supply and Quality Agreements in place
  • The ExM Snr Ops Mgr is responsible for all operational related activities including but not limited to
  • Sharing MSD’s Maufacturing objectives for the relationship with the contract manufacturers they manage & gaining alignment to these objectives with the contract manufacturers in a collaborative & professional manner
  • The ExM Snr Ops Mgr partners with the MPS expert and Tier 2 team (e.g. EQA, Procurement, SCM, GTO, Packaging Technology) to identify External Party OpEx / continuous improvement opportunities and supports implementation once approved. The Snr ExM Ops Mgr may commit resources provided Merck and the EP would share in the costs and benefits of such operational improvements
  • Materials Management (SAP entries, E2E planning, Logistics)
  • Proactively manage performance following company guidance
  • Is expected to provide coaching and support to ExM Ops managers & cross functionally to other groups
present
New York, NY
Associate Director External Manufacturing Virtual Plant Manager
New York, NY
Batz, Harris and Miller
present
New York, NY
Associate Director External Manufacturing Virtual Plant Manager
present
  • Proactively work with the customer and supply locations to improve the E2E supply chain
  • Set shared objectives for the “Tier 2” team & gain alignment with the “Tier 2” team & their line management in an inclusive manner working for the common good
  • Work on both tactical and strategic supply strategy
  • Quality issues (Deviation Management, Product Release, Change Control)
  • Managing remediation and/or improvement plans
  • Materials Management (COMET/SAP entries, E2E planning, Logistics)
  • MPS and Continuous Improvement activities
Education Education
Bachelor’s Degree in Chemistry
Bachelor’s Degree in Chemistry
Bowling Green State University
Bachelor’s Degree in Chemistry
Skills Skills
  • Strong leadership skills; project management expertise; excellent interpersonal, communication, and presentation skills
  • Excellent analytical, organizational, critical thinking and problem solving skills are mandatory for the role
  • Excellent communication (written and oral) and interpersonal skills are a pre-requisite for these positions
  • Ability to prioritize, organize and manage multiple tasks to tight deadlines
  • Demonstrated ability in performing in a fast paced, changing and demanding environment
  • Ability to work within a global and culturally diverse organization
  • Appreciation of Performance Metrics and their value in influencing supply chain results
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15 External Manufacturing resume templates

1

Lead-device Development & External Manufacturing Resume Examples & Samples

  • 50% Lead external manufacturing and development cross functional teams with key business partners for medical device, combination product, and pharmaceutical products through clinical development, product registration and commercialization
  • 10% Expertise in design controls, biocompatibility, sterilization validation, packaging validation, and shelf life stability programs
  • 5% Works closely with the procurement team on contract vendor selection, outsourcing models, and vendor evaluation audits, for medical device partners and combination products
  • 5% Establishing and fostering strong collaborative relationships with external design/development, manufacturing partners and service providers
  • 15% Change owner for manufacturing vendor change notifications; lead or assists with manufacturing deviations, customer complaints and product failure investigations
  • 15% Establish and maintain detailed project plans; define risks and recommend contingency plans as required
  • More than 10 years’ experience in the field of medical devices or combination products development and commercialization is required
  • A Bachelor’s of Science Degree in Engineering, Biotechnology, or Life Science is required
  • A Master’s of Science Degree or Masters of Business Administration preferred
  • Minimum of 5 years managing contractors and leading projects
  • PMP Certification preferred
  • Experience in developing and commercializing FDA regulated devices / combination products under design control regulations
  • Experience in supply chain handling, clinical manufacturing and distribution
  • Knowledge of industry standards (e.g.: ISO, AAMI, ANSI)
  • Strong managerial leadership skills with a track record of delivering new products to market with development partners
  • Strong communication skills (written and verbal), including experience presenting in front of multidisciplinary stakeholders
2

Senior External Manufacturing Engineer Resume Examples & Samples

  • A minimum of a Bachelor’s degree in Electrical, Mechanical or Electro-mechanical Engineering or a related discipline is required; an advanced degree is a plus
  • A minimum of 5 years of experience in a general electrical / electro-mechanical engineering role is required
  • Experience in a medical device manufacturing environment is preferred
  • Experience in electronics and/or electro-mechanical assembly of electronic devices, as well as small and/or large-scale production of electronic devices is required
  • Experience with pFMEA’s and/or dFMEA’s is preferred
  • Experience in a highly regulated environment is preferred
  • Experience in test systems for the manufacture of electronic devices is preferred
  • Prior experience supervising technical resources (technicians, engineers) is a plus
  • Experience with industry standards and quality / regulatory requirements is desired
  • Experience with reliability testing, assembly methods and plastic/metal component and process design is a plus
  • Experience with FDA, ISO, or related industry standards are desired
  • Familiarity with manufacturing techniques such as PCBA assembly, metal machining & plastic injection molding, test fixtures, GD&T, development systems and processes, and packaging of devices is preferred
  • The ability to perform independent assessment of component or process alternatives or modifications is preferred
  • Experience interacting with raw material suppliers and/or finished goods manufacturers is a preference
  • Prior experience participating in process efficiency improvement technology transfer into base business, or cost reduction projects is desired
  • A Process Excellence training or certification would be highly desired (Six Sigma or Lean Green or Black Belt)
  • Knowledge of statistical tools such as ANOVA, DOE, or Hypothesis Testing Tools would be a preference
  • Excellent verbal and written communication skills, a strong decision making and problem solving skills and outstanding interpersonal relationship and people skills are required
  • The ability to function as a team player and work in a matrix, cross functional organization is a must
  • This position will require up to 25% domestic and international travel.Industrial Manufacturing
3

Assoc Director, External Manufacturing Resume Examples & Samples

  • 30+ External Manufacturing sites (countries of Japan, Korea, China, Taiwan)
  • US$ 60+ Million in Spend
  • US$ 465+ Million in Net Trades Sales
  • Current Site portfolio includes Consumer, OTC and Medical Device products manufacturing
  • Accountable to drive all EM-Network KPIs (Compliance, EHSS, Q&C, Customer Service, Costs, NPD performance)
  • Provides leadership, coordination & successful implementation of EM-MAKE related programs & projects in support of business strategies
  • Represents EM-MAKE in Area Cluster Leadership Team. Is vital interface between EM Sites and all other End-to-End functions to drive compliance, customer service and cost objectives
  • Coordinate with and assist other sites (both within & outside APAC region) for the global or regional finished product sourcing change projects related to EM sites
  • Responsible for People development
  • Assist in the developing and deploying training system and programs in the region
  • A minimum of a Bachelor’s degree is required. An Masters or MBA is preferred
  • High Ethical value and Credo-based
  • Strong collaborative Leadership
  • Servant Leader, Leader as Role Model
  • Strategic Thinking and Zoom-In, Zoom-Out Elasticity
  • Effective communication and Interpersonal skills
  • Demonstrated strong leadership and people management
  • Strong knowledge on E2E Supply Chain, Manufacturing, Planning, Project Management and/or Engineering. Knowledge on Financial business processes and budgeting
  • Process Excellence (LEAN and 6-Sigma) knowledge & experience. GB or BB certification a plus
4

Product Specialist, External Manufacturing Resume Examples & Samples

  • Minimum 2 years’ experience working within Biotech/Pharmaceutical supply chain field
  • Highly motivated, able to work independently as well as part of a team
  • Ability to prioritize and drive for results
  • Fluent English (written and spoken) is a must
  • Bachelor’s Degree in Business, Life Science/ Quality/Engineering or Education in a related field
5

Associate Director, External Manufacturing Resume Examples & Samples

  • Establish relationship with the partners by defining a clear roles and responsibilities related to different phases of production and product distribution
  • Ensure productions schedules are maintained and that product is delivered according to company needs, translating company strategic imperatives to actionable goals
  • Establish and maintain overview of metrics and performance measures to ensure that appropriate signals can be determined in a timely fashion to ensure resilience of supply chain
  • Manage a group of up to 8 Product leads to ensure goals for CMO are met and maintained
  • Manage a budget up to ca $50 M ensuring all PO’s are actioned in a timely compliant manner
  • A minimum of 15 years’ experience in increasingly responsible roles in the management of manufacturing in the Biopharmaceutical Sector ideally with experience of management of CMOs
  • Previous experience in an international, matrix environment
  • Ability to navigate in ambiguous environment
  • Minimum of 5 years of experience managing teams; excellent leadership skills
  • Fluent English is a must, fluent German would be an asset
  • Bachelor or Master Degree Life Sciences subjects
6

Senior Manager, External Manufacturing Resume Examples & Samples

  • Serves as the External Manufacturing contact for DP development and process sciences concerning new product introduction technology transfer and technical troubleshooting
  • Provides support for site selection providing new technology assessment and manufacturing capability assessments
  • Developing and executing technical transfers including training the EM team and CMO’s teams in the new processes
  • Leading complex technical projects including process optimization or improvements, new technology introduction, new component introduction or material changes
  • Provides technical assessment of process changes, deviations, risk assessments and process validation
  • Coordinated all project activities with CMO PM’s and/or business partner manufacturing sites, including but not limited to: identifying and agreeing all technical deliverables, tracking of outputs and project step completion times, and providing any required associated reports
  • Travel to contract manufacturers or business partners, as required, approximately 25-50%
  • Provide regulatory filing support (IND, BLA, MAA, etc…)
  • Lead sub-team(s) in new projects, process improvements, CAPA implementations and/or process development projects
  • Write technical reports which concern DP Manufacturing or associated operations, if required
  • Assist in maintenance of product integrity and company reputation by assisting in the monitoring of cGMP compliance at drug product contract manufacturers
  • Technology Transfer experience with aseptic parenteral filling operations
  • Previous experience providing technical support and interacting with Contract Manufacturing organizations
  • Demonstrated technical expertise in drug product manufacture and/or product development
  • Significant knowledge of industry practices and regulations (e.g. GxP, ISO, ICH, etc.) across multiple health authorities (e.g. FDA, IMB, etc.)
  • Strong project management, interpersonal, cross- cultural, communication, negotiation and problem solving skills qualification preferable
  • Six Sigma certification preferred
  • BS in a scientific or engineering discipline with 8-10+ years of related experience, preferably in a pharmaceutical cGMP environment
7

Consumer Senior Strategicsourcing Manager External Manufacturing Resume Examples & Samples

  • Key leader in our recent M&A in Japan to represent source in the integration team for the new business we just acquired, manage all the commercial discussion with principle including contract, price and performance etc
  • Due Diligence study on all of the EMs potentially enter into the JJ network, provide recommendation to business of how should we better reshape the EM network to meet the business needs including quality, reliability, cost, innovation and reduce complexity
  • Build strong relationship with the principle to ensure the EM network optimization plan is aligned and lead cross-functional team to remediate and implement the plan
  • Supplier development: Lead supplier identification/selection process and supplier relationship management to continuously meet J&J business needs
  • Own Cost Improvement Programs (CIP) taking into account end to end supply chain objectives
  • 1)Be fully accountable for CIP target (one-team result)
  • 2)Lead CIP on-time and flawless implementation
  • Own any investment plan at supplier side
  • Inflation control: Keep track of category external/macro situation; analyze potential cost impact; lead the negotiations with suppliers to minimize/eliminate inflations that come from feedstock price fluctuation, currency fluctuation, etc
  • Support New Product Introduction/Development (NPI/NPD)
  • 1)Lead new EM development with other key functions to support NPI/NPDs
  • 2)Identify capable/competitive suppliers together with alternative options to meet new product needs and cost objectives
  • Supplier Capacity Management: Lead the supplier capacity analysis to make sure reliable material supply to meet J&J requirement
  • Contract management: Facilitate the establishment of optimum supply agreements and ensure that they are aligned with category strategy to ensure business continuity through the agreements
  • University degree in Business, Operations/Logistics, Engineering, Science
  • 10 years relevant work experience in international environment
  • Strategic sourcing, Supply Chain experience, External Manufacturing Experience is a plus
  • Analytical and Process oriented
  • Commercial, Strategy Development, and Negotiations skills
  • Communication and presentation skills
  • Decision Making / Problem Solving
  • Commercial Agreements/Legal knowledge
  • Quick adaptability to changes and new environment
  • Ability to work effectively under pressureContract Manufacturing
8

Associate Director, External Manufacturing Resume Examples & Samples

  • Global Category Management: Leads Global Category Management teams to develop and implement strategic source plans for one or more categories of spend
  • Sourcing Management – Uses the Sourcing Management Process to manage assurance of supply, quality, service, cost, innovation and regulatory compliance within Global or International category of spend, resulting in breakthrough strategies which optimize value and ensure appropriate risk management. Understands the Sourcing Management Process and how to apply required tools in the creation and implementation of source plans
  • Proactive Cost Management: Achieves cost control, cost reduction, and cost containment targets, and adds value to area of expenditure through a strong total cost orientation
  • Market Knowledge and Insight: Uses thorough market knowledge and data analysis to gain critical insights that drive the selection of Sourcing Strategies and continuous improvement activities
  • Technical Expertise: Working knowledge of biopharmaceutical/vaccine processing techniques and capabilities, including cell culture and fermentation; harvest and recovery; viral removal and inactivation; and purification processes such as tangential flow filtration, centrifugation, and size exclusion and adsorptive chromatography. Working knowledge of quality, safety and compliance requirements associated with biopharmaceutical/vaccine processing
  • Working knowledge of Lean/Six Sigma process aimed to improve productivity, yields, cycle times, quality and compliance
  • Expertise and practical experience in project management
  • Supplier Management and Conditioning: Responsible for building relationships with Global, International and Enterprise suppliers and managing supplier performance against business requirements using proven processes; ensures adequate inclusion of diversity suppliers in RFPs and contracts as applicable. Supports major Regional supplier relationships
  • Minimum of five (5) years experience in manufacturing industry, preferably in FDA regulated environment
  • Three or more years experience in strategic sourcing or related role, including Contract Manufacturing of Pharmaceutical, Biological, or Consumer Care products
  • Experience in international business desirable
  • Knowledge of Procurement related business processes, including commercial negotiations and contracting
  • Cultural awareness and sensitivity required
  • Demonstrates Leadership Standards at the Manager or Manager of Manager level, with particular strengths in Championing Change, Communicate Candidly, Build Talent, Achieves Results
9

External Manufacturing Source Lead-otc Resume Examples & Samples

  • Bachelor’s Degree (Procurement/ SupplyChain/ Economics/ Business/Scientific/Engineering or related fields)
  • 10 years of supply chain / procurement experience
  • Experience working in Pharm / OTC
  • Must have experience working in a cross-functional environment
  • Strong working knowledge and proven results in Strategic Sourcing/Procurement
  • Knowledge of manufacturing or contract manufacturing
  • Experience working in the area of External Manufacturing
  • Experience working/leading regional/global team.Sourcing
10

Manager of External Manufacturing Resume Examples & Samples

  • Drive the External Manufacturing vision for, with and through the stakeholder community
  • Own relationship with assigned suppliers: Monitor performance, develop and lead regular performance reviews (S&OP, CIP execution, QBR, Planning, Quality reviews, etc.), oversee product tech transfers and engage suppliers in lean process improvements. Manage supplier operations as a virtual plant manager
  • Drive value to our Customer & bring valuable alternative options to stakeholders
  • Have a passion for being customer-focused and collaborative within the organization
  • Foster a culture of high performance within the teams and with suppliers
  • Work with suppliers to bring innovative solutions for unmet needs
  • Conduct CIP ideation sessions with suppliers; develop the vision, strategy and implementation plan that will effectively meet the long range requirements of the business partners and deliver the maximum value for J&J
  • Develop Ops Plans (incl. budgets, volume planning, etc.) with EM sites; Ensure alignment on the outcomes with key internal partners
  • Identify potential Quality/Regulatory, Technical and/or Supply Chain challenges. Work with key internal stakeholders and EM sites to resolve
  • Develop, implement and lead proactive change and risk management processes for suppliers
  • Deliver on financial, service, reliability, quality, and growth commitments
  • Own New Product Introduction process with EMs; Plan and direct NPIs with key internal stakeholder alignment, lead J&J/EM resource meetings and ensure successful NPI launch
  • Escalate issues that may impact our overall business
  • BSc in Engineering, Business, Supply Chain or Operations required
  • CPSM, CSCP, CPIM, PMP, or other certification or relevant experience desired
  • 4+ years of related experience in the Medical Devices field will be highly regarded
  • Manufacturing operations and supply chain experience
  • Strong level of credibility with internal customers, and with the supplier community
  • Strong influencing skills with ability to see issues from multiple viewpoints and understand differing needs of stakeholders (e.g., businesses, Procurement LT, Marketing, R&D, and Supply Chain); has "presence"
  • Demonstrated strong leadership, communication, influencing and collaboration
  • Negotiation and contract executing experience
  • Able to prioritize requests, and propose effective cost/customer service alternatives
  • Ability to show judgment in developing new approaches and resolving issues
  • Ability to show strategic thinking
  • Strong verbal and written communication skills with ability to confidently present complex information to stakeholders at all levels both internally and externally
  • Travel requirement globally of around 30%
11

External Manufacturing Make Associate Manager Resume Examples & Samples

  • New Product (approx. 30% of time/effort)
  • Execute / supports NPI/ NPD roll outs/ reformulations/ packaging & artworks changes/ technical transfers and site readiness at External Manufacturing and deliver against established timelines, forecasted volumes and costs
  • Coordination and implementation of Quality and compliance improvement initiatives with Contract Manufacturers in partnership with the Q&C team
  • Execute efficient implementation of new Supply Chain with new External Manufacturing sites / Inbound Logistics and / or new markets
  • Supply Management and Continuous Improvement (focus on External Manufacturing) (approx. 60% of time/effort)
  • Develop identified External Manufacturers through identification of their needs and implementation of continuous improvement initiatives in the scope and in alignment with the defined Sourcing Strategies. Lead execution through partnering with various stakeholders to ensure alignment with MAKE approach, consistency in method / tools and access to resources
  • Day-to-day management of supply from external suppliers in close collaboration with Planning functions to identify customer supply risk and agree on corrective actions
  • Manage & develop risk assessment overview for identified External Manufactures and implement preventive actions
  • Control budget and manage spending of non-standard costs from projects and change controls with contract manufacturers
  • Support Supply Chain Performance monitoring and deployment of corrective actions
  • Data Management (approx. 10% of time/effort)
  • Run data analysis in the scope of medium-term capacity planning and performance management with Contract Manufacturers
  • Master Degree in Science, Engineering, or commerce with equivalent technical experience
  • 3 years prior work experience in a regulated industry - OTC and Pharmaceutical is preferred
  • Operational Excellence Certification (Process Excellence, Lean, etc)/ APICS Certification/ Project Management Certification is preferred
  • Process Excellence and Continuous improvement experience in Supply Chain and/or manufacturing environment is preferred
  • Experience working in the area of FMCG or OTC products
12

Director, External Manufacturing Resume Examples & Samples

  • Oversee and lead interactions with external manufacturing partners to assure quality and compliance related matters meet appropriate cGMP and regulatory requirements
  • Manage and provide oversight to all external manufacturing partners to ensure compliance of established manufacturing agreements
  • Lead cross-functional Contract Manufacturer Relationship Teams (CRTs), comprised of Quality, Sourcing, Product Sciences, etc. to ensure Kite standards are met
  • Ensure the timely delivery of products and, if necessary, act as person in the plant during CMO start up activities
  • Partner with the Quality Assurance group, manage and ensure the timely review and release of product from external manufacturing partners
  • Proactively develop, manage and improve contract manufacturer performance
  • Serve as primary point of communication/escalation for issues
  • Set goals for CRT members with functional heads
  • Support resource plans and budgets for the CRT
  • Assure the CRT has “one voice” to 3rd parties
  • Review metrics with suppliers and internal teams
  • Communicate changes and issues with suppliers
  • Ensure implementation of CAPAs
  • Project and account plans (capacity, saving, changes)
  • Lead and review continuous improvement projects
13

Site Leader, External Manufacturing Resume Examples & Samples

  • Managing all aspects of the relationship to deliver reliable product supply at the total lowest cost while meeting or exceeding all customer service compliance and product(s) requirements
  • Assisting in negotiating and maintaining long-term multi-million dollar contracts
  • Managing all product supply aspects that a Third Party provides (new product launches, business planning, budgeting, procurement of components/raw materials, project management, equipment and packaging engineering, product quality, adherence to the appropriate GMP’s (food, drug and/or dietary supplement) and non-conformance elimination)
  • Driving continuous improvement for internal and external processes
  • Communicate with all levels of management at the contract site and McNeil/J&J
  • Assist in developing strategic global sourcing strategies for key technologies in support of both new products/businesses and existing businesses
  • Responsible for training all new CSM in primary job responsibilities
  • Attend GMP training on the schedule designated for role and as appropriate for role
  • Adhere to strict compliance with procedures applicable to role
  • Exercise the highest level of integrity in the tasks that perform
  • In a timely and prompt manner, identify, report and seek correction for deviations noted in workplace
  • Embrace a behavior of employee involvement and commitment to doing the job right the first time
  • Ensure employees under scope of responsibility are trained in required procedures for the execution of their role and maintain current with training requirements during the year
  • Promote an environment of employee involvement in the workplace
  • Seek prompt identification, reporting and correction of deviations in the workplace as note by employees
  • Bachelor’s Degree is required; Technical degree or MBA is preferred
  • Minimum 5 years in the pharmaceutical industry or consumer industry is required
  • Experience in supply chain with experience in several disciplines within operations (including manufacturing) is required
  • Experience in development and commercialization of new products is preferred
  • Experience with regulated products is required
  • Strong knowledge of general manufacturing principles and practices and new product commercialization process is required
  • Strong project management skills for cross-functional, cross-company projects is preferred
  • Good executive communication skills (writing, verbal and listening) is required
  • Demonstrated understanding and interpretation of cGMP requirements in the manufacturing environment is required
  • Strong business acumen is required
  • Negotiation skills are preferred
  • Proven analytical/technical aptitude & competence is required
  • Good knowledge level of Regulatory Pharmaceutical development requirements is preferred
  • MRP and PC literacy is required
  • Process Excellence Certification is preferred.Contract Manufacturing
14

Director of External Manufacturing Resume Examples & Samples

  • B.S. Engineering – Chemical Engineering preferred; Advanced degree a plus
  • 15 years’ experience in a combination of: the management of drug manufacturing, filling and packaging either directly or through qualified CMOs; procurement; product development
  • Familiarity with ERP solutions – Dynamics AX or NetSuite preferred
  • Experience with continuous improvement initiatives and manage cross-functional teams
  • Analytical and problem solving skills in the production areas relevant to the scope of the assignment
  • Experience with Microsoft Office Suite: Excel, Word, Project and Power Point
15

Associate Manager External Manufacturing Make Resume Examples & Samples

  • Demonstrated leadership / interpersonal skills, communication
  • Proactive, independent, self-leadership
  • Partnership, collaboration and teamwork skills
  • Demonstrated ability to work in a matrix environment
  • Cultural sensitivity – previous exposure to cultural diversity
  • End to End Supply Chain understanding and track record of improvements in processes that maximizes organizational valueProduction Planning
16

Biologics External Manufacturing Resume Examples & Samples

  • Act as primary BEM supply chain contact for internal and external customers for product inquiry, supplier performance, shipments, scheduling, and transactional activities
  • Proactively provide forecasts and firm orders to suppliers to fulfill contract requirements in alignment with the global supply strategy. Ensure that the Drug Substance and Drug Product Manufacturing plans are aligned with the biologics network capacity strategy
  • Support distribution and logistics transactional and planning activities to meet customer requirements. Develop plans for allocations and track inventory for market specific requirements
  • Work effectively with Global Supply Chain and downstream processing sites to ensure timely delivery of customer orders and communication of issues, risks, and opportunities
  • Membership of BMS virtual supplier management team, interfacing with Quality, MS&T, SRM and Procurement to support resolution of any supply risks that may arise
  • Issue indirect purchase orders onto CMO’s for miscellaneous expenses and charge to appropriate P&L
  • Resolve invoice discrepancies or other purchasing price variances
  • Maintain SAP master data and aides in development, implementation, and tracking of supply chain performance metrics
  • Provide input into inventory projections to highlight how forecast trends are driving projection
  • Proactively highlight any potential inventory write off risk
  • Manage up to 3 direct reports as required
  • Demonstrated Supply Chain knowledge; minimum of 5 years of experience in supply chain and pharmaceutical /biotech operations
  • Well versed in capacity planning, purchasing, materials management and import/export, and must have a strong command of SAP and analytical tools
  • Strong leadership skills; project management expertise; excellent interpersonal, communication, and presentation skills
  • Must be able to interface well with other departments and work effectively in a matrix environment. Must demonstrate excellent written and verbal communication skills and work well with diverse staff and stakeholders in multiple locations
  • Ability to prioritize, organize and manage multiple tasks to tight deadlines
  • Appreciation of Performance Metrics and their value in influencing supply chain results
  • BS. degree, with M.B.A. strongly preferred 
  • 5 years experience in the pharmaceutical industry/ Supply Chain or manufacturing environment is required
  • APICS: CPIM and/or CSCP preferred
  • Master scheduling, forecasting and customer service, and/or inventory management is required, ideally combined with the use of Enterprise Resource Planning (ERP) systems
  • Excellent analytical, organizational, critical thinking and problem solving skills are mandatory for the role
  • Ability to work within a global and culturally diverse organization
  • Demonstrated ability in performing in a fast paced, changing and demanding environment
  • Qualified to degree standard in the Supply Chain, Engineering, or Business Studies discipline, Masters is a plus
  • Excellent communication (written and oral) and interpersonal skills are a pre-requisite for these positions
17

Associate Director Biologics Quality Operations External Manufacturing Resume Examples & Samples

  • Conducts quality due diligence assessments for pre-approval considerations of new external partners. Supports the partner in remediation of due diligence and/or pre-contract audit gaps. Assures the development and maintenance of a Quality Agreement with the external partner. Acts as the Quality expert on Merck behalf regarding contractual negotiations and provides input into the development of commercial contractual agreements with the external partner on quality related terms
  • Collaborates with the external partner to ensure that effective and robust Quality Systems and Quality management are in place. Provides on-site guidance in the preparation of metrics, procedures and guidelines where warranted. Provides proactive support in training and coaching to initiate quality improvements within Operations and Quality; reviews Annual Stability and Product reviews
  • Acts as the Merck Quality point of contact for technology transfers to the external partner and leads all quality aspects of the technology transfer
  • Executes a program of calibrated Quality oversight based on the scope of operations, product type, capabilities and quality and compliance performance of the external partner
  • Approves the release of vaccine and biologic products with the assurance that the goods were produced in conformance to all applicable policies/procedures of Merck and compliance with all governing regulations
  • Is responsible for defining Quality expectations on Process Change Requests (PCRs) submitted by the external partner and ensuring conformance to all PCR requirements prior to authorizing release of batches made under the changes; will ensure all validation expectations are met, where necessary, by on-site support for demonstration batches or validation batches
  • Guides investigations conducted by the external partners' into abnormal operational occurrences such as batch rejections, atypical events, customer complaints etc. Coordinates support from appropriate staff groups and recommends corrective measures; assists in the coordination of significant investigations including Fact Findings and the coordination of product recalls as needed
  • May act as or support the regulatory compliance liaison on Merck behalf to interface with regulatory agencies
  • Closely collaborates with appropriate business and operations areas to achieve Merck objectives
  • Minimum of 10 years’ experience in the pharmaceutical industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements
  • Experience with biologic and/or vaccine quality assurance
18

Director External Manufacturing Resume Examples & Samples

  • Demonstrated operational leadership by developing, leading and implementing change as well as Operational Initiatives as determined by the Sr. Director of External Manufacturing
  • Consistently demonstrates broad thinking on complex problems and drive solutions requiring cross-functional alignment
  • Lead high-profile and critical manufacturing projects of strategic importance to Regeneron
  • Exhibits a degree of ingenuity, creativity and resourcefulness in a sometimes evolving and ambiguous environment
  • Exhibits confidence and a high emotional IQ
  • Consistent record of overseeing and managing a portfolio of complex technical projects and Project Management organization
  • Proven track record of developing and managing people
  • Requires a BA/BS in any physical or Biological Science with 15+years industry related experience. 13+ years (with BA/BS); 11+ (with MA/MS or Ph.D.) of relevant progressive project management and experience managing a team in the drug development industry
  • Previous experience in collaborating with Contract Manufacturing organizations.PMP certified, MBA considered a plus
  • Fluent in English with a preference given to candidates with competencies in German and/or French (oral and written)
19

Engr Senior Prin, External Manufacturing Tl Resume Examples & Samples

  • BS above
  • 8 years working experience above
  • Foundry or supplier experience plus
20

Technical DRA Manager for External Manufacturing Resume Examples & Samples

  • Timely compilation and management of all necessary documentation for regulatory submissions to support the CMC variations
  • Support worldwide filings, as appropriate and as requested by corporate partners
  • Based on Corporate Policies and Guidelines, as well as the Good Manufacturing Practices, maintain the correct operation of the documentation systems during the preparation of the product technical dossiers
  • Work closely with Roche Quality Assurance, Manufacturing, Quality Control, Validation, Manufacturing Sciences and Technology (MSAT), Manufacturing Network and Global Technical Regulatory groups to assure the relevant product and regulatory expectations are met
  • Assess upcoming events which might have a significant impact on the implementation of the technical change and define/coordinate needed actions
21

Production Lead, External Manufacturing Resume Examples & Samples

  • Leads or coordinates matrix teams within a product program
  • Drives identification of key business areas that require established governance and participates in governance activities
  • Supports high performing, stable, compliant and cost effective relationships with CMOs
  • Identifies and communicates risks and issues that impact quality, compliance, project timelines, resource requirements, finances or the overall business relationship by proactively managing risks/capabilities and developing mitigation plans
  • Defines and ensures that supply level agreements are set and achieved
  • Measures performance of CMOs through implementation and trending of key performance indicators and generates improvements plans as needed
  • Proactively identifies and leads improvement projects covering quality, service, cost and innovation
  • LI-POT5
  • 3-7 years of experience in biotech/pharmaceutical manufacturing/supply chain
  • Excellent knowledge of ERP production modules, QA controlled documentation software, Change Management principles, and Manufacturing Deviation reports
  • Demonstrated project leadership skills. Solid project management experience to enable effective management of projects and teams
  • Experience creating presentations and presenting to varying audiences
22

Manager Sourcing External Manufacturing Resume Examples & Samples

  • Sourcing Strategy
  • Buying Strategy
  • Manage relationship with Co-Manufacturers
  • Drive for result and leadership
  • Business acumen and Entrepreneurial spirit
  • Strategic agility - perspective
  • Organizational agility across regions, functions and hierarchies
  • In depth experiences in business , ideally within Procurement and/or Manufacturing,
  • Embracing manufacturing and commercial environments
  • Experience of managing through multi-functional and multi-cultural projects and teams, preferred in FMCG
23

Senior Manager External Manufacturing Make Resume Examples & Samples

  • A minimum of a Bachelor’s degree is required
  • A minimum of eight (8) years related experience in related areas OR an M.B.A. with a minimum 6 years’ experience in related areas
  • Related areas include Contract Manufacturing, Supply Chain/Operations, Manufacturing, Procurement, Supply Chain Sourcing, Project Management, Technical Transfer, Product Development, R&D, and/or Supply Planning
  • Experience Consumer Goods, Medical Device, Pharma
  • Experience with people management or managing direct reports is preferred
  • Experience with executive level communication is preferred
  • Internet and MS Office Suite proficiency is required
  • Prior knowledge of Advanced planning systems such as ERP, MRP, and SAP is a plus
  • Prior experience in project management or product development is desired
  • Experience working in Manufacturing Operations required, specifically in a GMP environment-supervising people in a plant would be preferred
  • Strong project management skills and knowledge of GMPs is preferred
  • An entrepreneurial self-starter with strong oral and written communication skills, comfortable communicating across functional levels is required
  • Experience with Six Sigma/Process Excellence tools, training and/or certification is preferred. Strong analytical skills are a requirement
  • This position is located in Clearwater, FL and may require up to 25% of domestic and international travel. This position will also be transferred to Skillman, NJ after 2-3 years’ time.Contract Manufacturing
24

Manager, External Manufacturing Resume Examples & Samples

  • Travel to contract manufacturers or business partners, as required
  • Provide regulatory filing supports (IND, BLA, MAA, etc.)
  • Ensure product integrity and company reputation by assisting in the monitoring of cGMP compliance at drug product contract manufacturers
  • Extensive knowledge and experience with full-scale drug product manufacturing from formulation through the final package
  • Broad knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations
  • Proficient in Excel, PowerPoint, Visio, Word, etc. in addition to experience working within shared work environments
  • Senior Manager requires a minimum of a BA/BS in any physical or Biological Science with 10+ years industry related experience. 8+ years (with BA/BS), 5+ years (with MA/MS or PhD) of relevant and progressive parenteral manufacturing experience
  • Manager requires a minimum of a BA/BS in any physical or Biological Science with 8+ years industry related experience. 5+ years (with BA/BS), 3+ years (with MA/MS or PhD) of relevant and progressive parenteral manufacturing experience
25

External Manufacturing Technical Contractor Resume Examples & Samples

  • Support validation of manufacturing and packaging processes at Contract Manufacturers, for new products and for changes to existing products
  • Review and approve validation protocols and reports
  • Review changes to manufacturing processes, raw material sources, manufacturing equipment, and evaluate technical requirements to implement change (e.g. determine if process validation is required)
  • Provide input/guidance into resolution of production issues/deviations to ensure continuity of Supply. Troubleshooting in manufacturing
26

Director External Manufacturing Resume Examples & Samples

  • Leads the development of core competencies in external manufacturing processes, standards and tools to enable capacity, support new product launches and unlocks supply chain value
  • Provides leadership to ensure that external manufacturers operate in accordance within established standards and guidelines for quality, food safety, efficiency, inventory control, material handling and reporting. Ensures that vendors maintain up-to-date documentation for compliance with kosher, organic, insurance and other standards. Develops and maintains vendor scorecards to facilitate continuous improvement
  • Manages relationships with external manufacturers. Ensures that company objectives are met for production scheduling, supply quantities, timely deliveries, quality control, cost of goods, inventory control, waste and other metrics. Monitors work of external manufacturers to identify potential conflicts, supply issues and other developments that could affect the Company's ability to meet demand
  • Partner with procurement to ensure that external manufacturing agreements are in place, and in compliance within each area of assigned external manufacturing
  • Directs teams and activities to identify opportunities to improve processes, service levels, product quality, efficiency and reduce cost
  • Manages cross-company interface and coordination of all external manufacturing functions to ensure that optimal business plans are developed and executed
  • Partners with internal manufacturing team to drive network strategy and operations excellence
  • Managing manufacturing and/or external manufacturing supply relationships (10 years)
  • Project management in a dynamic, change oriented organization (10 years)
  • Progressive experience in multiple areas of expertise within manufacturing, logistics, engineering and/or consumer goods industry experience (10 years)
  • Budget planning and management (7 years)
  • Demonstrated manufacturing leadership of site operations including planning, procurement/inventory management, manufacturing, warehousing/distribution, food safety/food quality, and continuous improvement (7 years)
  • Ability to manage multiple priorities and meet deadlines in a fast-paced and changing environment
  • Ability to apply sound business principles and practices to project management and change management processes
  • Abilty to lead teams to create an optimal supply chain to meet production supply requirements, reduce costs and manage within budget targets on a consistent basis
  • Familiarity with American Institute of Baking (AIB), Good Manufacturing Practices (GMP), and Hazard Analsysis and Critcial Control Points (HACCP) standards
27

Assoc Dir External Manufacturing Resume Examples & Samples

  • The ExM Snr Ops Mgr is the primary owner and single point of contact for MSDs relationship with the contract manufacturer for all dealings between the two parties. The ExM Senior Ops Mgr serves as the main liaison & gate keeper between MSD and the contract manufacturer for commercial supply and establishes boundaries, ground rules of engagement, and collaboration between the Contract Manufacturer and MSD, informed by the Supply and Quality Agreements in place
  • The ExM Snr Ops Mgr is responsible for all operational related activities including but not limited to
  • Sharing MSD’s Maufacturing objectives for the relationship with the contract manufacturers they manage & gaining alignment to these objectives with the contract manufacturers in a collaborative & professional manner
  • Lead prioritization with the tier 2 team and provide & reflect the customer demand and business perspectives for the Tier 2 team
  • Materials Management (SAP entries, E2E planning, Logistics)
  • Quality Issues (Deviation Management, Product Release, Change Control)
  • Oversight of shop floor production (determining when an ExM functional rep should be deployed to the External Party’s (EP) facility)
  • Understand the customer requirements and customer demand. Alignment of internal / external stakeholders and upstream / downstream nodes in the value chain
  • Communicate with customer location, supply locations and stakeholders in such a manner as to ensure that issues are well understood and appropriate mitigation and action can take place. The ExM Snr Ops Manager must ensure that there is coordinated and consistent communication across all functions represented on the Tier 2 team
  • Proactively work with the customer and supply locations to improve the E2E supply chain
  • The ExM Snr Ops Mgr partners with SCM, Procurement, EQA, Research, and GTO on commercial aspects of relationship, including identification, selection, negotiation and potential termination of agreements as required. ExM Snr Ops Mgr may not be involved in all transactional interactions if they can be managed/delegated responsibility to a functional area but will be kept apprised of status/resolutions, etc. & remain responsible for the outcome
  • The ExM Snr Ops Mgr facilitates the collection of External Partner (EP) capacity information (e.g. stated capacity, firm capacity, future capacity plans, time horizon / lead times required, comments/concerns, etc.) in preparation internal assessment as well as site capacity exercises
  • The ExM Snr Ops Mgr is responsible for inventory control. Depending on the location of goods (at External Party or at MSD), ExM Snr Ops Mgr ensures adequate documentation of material disposition. In some markets, ExM Operations may need to witness the destruction of goods (to prevent counterfeiting) or have the EP certify the destruction, per destruction procedures described in the MSA
  • The ExM Snr Ops Mgr partners with the MPS expert and Tier 2 team (e.g. EQA, Procurement, SCM, GTO, Packaging Technology) to identify External Party OpEx / continuous improvement opportunities and supports implementation once approved. The Snr ExM Ops Mgr may commit resources provided Merck and the EP would share in the costs and benefits of such operational improvements
  • The ExM Snr Ops Mgr facilitates, & with the contract manufacturer leads the periodic Business Review Meetings (BRM)
  • Is expected to take cross functional ownership of processes procedures within ExM at a regional or global level (eg: QMS SO/SSO, EHS, etc.)
  • Is expected to provide coaching and support to ExM Ops managers & cross functionally to other groups
  • Is expected to be comfortable working in a flexible, matrix & changing environment
  • Is expected to be able to be able to communicate across all levels in MSD Manufacturing and with contract manufacturer without need for direct support or review from the Operations Director
  • Proactively manage performance following company guidance
  • Manage the development plans of direct reports and sponsor and facilitate actions against these plans
  • 7+ years experience in commercial/business and manufacturing (within at least two of the following: Operations, Quality, Technology, Planning, Procurement) function required (or equivalent combination of education/experience)
  • Significant Manufacturing experience and knowledge (shop floor) with line management responsibility in high volume operations is a must
  • Experience with Injection Molding
  • Experience with Domestic and International Regulatory Requirements associated with DDS/Devices and Combination Products
  • Has demonstrated strong leadership, continuous improvement mindset, managerial, team building abilities and sensitivity to diverse cultures
  • Ability to apply understanding of the end-to-end supply chain
  • Must possess the ability to work independently with minimal coaching
28

Biologics External Manufacturing Resume Examples & Samples

  • Act as primary BEM supply chain contact for internal and external customers for product inquiry, supplier performance, shipments, scheduling, and transactional activities and providing supply chain support for assigned products and CMO’s
  • Work effectively with Global Supply Chain and upstream/downstream processing sites to ensure timely delivery of customer orders and communication of issues, risks, and opportunities. Owns the issuance of the rolling forecast and firm orders to CMO as contracturally defined
  • Purchases defined starting materials from external/internal vendors as needed to meet production schedule at CMO. Coordinates/manages issues of supply of starting materials within the network as required
  • Coordinate allocation of inventory to downstream supply chain node through active participation in supply chain subteam and site cluster meetings, aligned to BMS inventory policies
  • Lead site S&OP process for assigned portfolio
  • Membership of BMS virtual plant team, interfacing with quality, MS&T, supplier relationship manager, finance and procurement to provide supply chain oversight and support resolution of any supply risks that may arise. Provide supply chain project support and leadership as required
  • Manage CMO invoices linked to the P&L working directly with finance. Resolve invoice discrepancies or other purchasing price variances, and proactively identify and work to eliminate any financial risk
  • Maintain SAP master data for assigned portfolio. Ensure SAP information is up to date and accurate
  • Aides in development, implementation, and tracking of supply chain performance metrics. Responsible for performance against these metrics for assigned portfolio with a mindset of continuous improvement
  • Actively contribute towards inventory budget targets through performance tracking of actuals versus plan
  • Accountable functional ownership to enable success of the BEM team as a whole
  • 3-5 years demonstrated Supply Chain knowledge
  • Supply chain planning and project management experience
  • Experience working in a tolling environment and/or with external vendors
  • Excellent interpersonal, communication, and presentation skills
  • Knowledge of Pharmaceutical Industry and appreciation of the competitive environment and its impact on driving change in the organization
  • Knowledge of logistics, financial, and information flows
  • Excellent PC and systems skills with prior experience working in SAP
29

Associate Director External Manufacturing Virtual Plant Manager Resume Examples & Samples

  • The External Manufacturing Vitual Plant Manager (ExM VPM) is the primary owner and point of contact for Manufacturing Division’s relationship with the contract manufacturer for all dealings between the two parties. The Associate Director, ExM serves as the main liaison & gate keeper between Manufacturing Division and the contract manufacturer for commercial supply and establishes boundaries and ground rules of engagement between the Contract Manufacturer and Manufacturing Division informed by the Supply and Quality Agreements in place
  • The ExM VPM is the leader of the External Manufacturing “Tier 2” Team. This team consists of nominated representatives from SCM, EQA, GTO and Procurement. This role must lead this team to delivery weekly/monthly and annual business objectives, to the required EHS and quality compliance standards
  • The ExM VPM is responsible for all operational related activities including but not limited to
  • Sharing Manufacturing Division’s objectives for the relationship with the contract manufacturers they manage & gaining alignment to these objectives with the contract manufacturers in an inclusive & professional manner
  • Dispute resolution (w/ appropriate escalation)
  • Materials Management (COMET/SAP entries, E2E planning, Logistics)
  • Quality issues (Deviation Management, Product Release, Change Control)
  • Technology issues
  • MPS and Continuous Improvement activities
  • Managing remediation and/or improvement plans
  • Work on both tactical and strategic supply strategy
  • The ExM VPM must link to the customers and suppliers of their contract manufacturers and to other stakeholders involved in the end to end supply chain. They must
  • Understand the customer requirements and customer demand
  • Work directly with those customers and build and maintain relationships with key team members at those customer locations and with other stakeholders (eg: SCM, D&L..)
  • Understand the constraints and risks associated with supplying each customer, both at the contract manufacturer and also within the supply chain between the contract manufacturer and the customer location
  • Communicate with customer location, supply locations and stakeholders in such a manner as to ensure that issues are well understood and appropriate mitigation and action can take place. The ExM VPM must ensure that there is coordinated and consistent communication across all functions represented on the Tier 2 team
  • Act as a conduit between the Contract Manufacturer and Manufacturing Division
  • The ExM VPM partners with SCM, Procurement, EQA, and GTO on commercial aspects of relationship, including identification, selection, negotiation and potential termination of agreements as required. ExM VPM may not be involved in all transactional interactions if they can be managed/delegated responsibility to a functional area but will be kept apprised of status/resolutions, etc. & remain responsible for the outcome
  • The ExM VPM participates on the cross-functional team that Product Source Management assembles following a Supply Chain Committee (SCC) approved siting/source change to an external party and assume primary ownership of the new source
  • The ExM VPM facilitates the collection of External Partner (EP) capacity information (e.g. stated capacity, firm capacity, future capacity plans, time horizon / lead times required, comments/concerns, etc.) in preparation internal assessment as well as site capacity exercises
  • The ExM VPM is responsible for maintaining the integrity of the Master Supply Agreement (MSA), ensuring alignment with the Supply and Quality agreements and appropriate document revision and distribution control
  • The ExM VPM is responsible for inventory control. Depending on the location of goods (at External Party or at MSD), ExM VPM ensures adequate documentation of material disposition. In some markets, ExM Operations may need to witness the destruction of goods (to prevent counterfeiting) or have the EP certify the destruction, per destruction procedures described in the MSA
  • The ExM VPM is responsible for ensuring contract terms agreed upon by Manufacturing Division and the External Party are executed including purchase orders, forecasts, deliveries, and approving invoice payments
  • The ExM VPM partners with the MPS expert and Tier 2 team (e.g. EQA, EQA, procurement, SCM) to identify External Party OpEx / continuous improvement opportunities and supports implementation once approved. The Snr ExM Ops Mgr may commit resources provided MSD and the EP would share in the costs and benefits of such operational improvements
  • 10-15 Years
30

External Manufacturing Sourcing Specialist Resume Examples & Samples

  • Manage assigned spend portfolio with primary focus on the North American region
  • Develop knowledge of the supply market and suppliers Conduct Strategic Sourcing Projects including market analysis and the development of short and mid-term strategies
  • Work with functional and business partners to understand business requirements and align the sourcing strategy and implementation plans
  • Conduct Request For Information (RFI) and Request for Proposal (RFP) utilizing Dow’s electronic sourcing tools
  • Negotiate pricing, payment and delivery terms and execute contract agreements as appropriate
  • Provide the Procure to Pay (P2P) organization with the necessary information to enter new and/ or update system contract agreements in SAP
  • Manage Supplier Relationships including the commercial relationship; resolution of escalated issues from Provide the Procure organization and business partners. Monitor supplier performance against key performance indicators
  • Understand and practice appropriate work process governance and compliance
  • Bachelor’s degree is required
  • 2-5 years’ experience in strategic sourcing, market/sell, supply chain or other commercial roles is required
  • Strong written and oral communications skills
  • Ability to apply Six Sigma methodologies – Green Belt Project Certification or ability to complete
  • Demonstrated analytical skills, ability to work with large amounts of data
  • Demonstrated skills in negotiation or influencing the decision making process
  • Demonstrated skills in time and project management
  • Proven ability to solve problems and think strategically
  • Ability to work across regions and functions
31

Manager External Manufacturing Resume Examples & Samples

  • Experience in a Supply Chain or Production function (ideally manufacturing experience and E2E Supply Chain or Planning experience)
  • Track record of improvements in processes that maximizes organizational value
  • Experience working in the area of FMCG and / or OTC products
  • Ability to work in a matrix organisation
  • Good communication skills with ability to influence
  • Proactive, independent, self-leadership paired with collaboration and teamwork skills
  • High integrity and ethical behavior
  • Knowledge of general manufacturing principles and practices and compliance requirements
32

Quality Lead of Licensing & External Manufacturing Resume Examples & Samples

  • Assures that all products produced at supplier sites are safe for consumption and conform to the intended product design. This includes being responsible for change management and process improvement
  • Manages the quality audit function for supplier sites while assessing and ensuring the ongoing effectiveness of the corrective and preventative action process within the framework of the Global Food Safety Initiative (GFSI) compliant Quality Management System, such as ISO 9000
  • Represent the “owners” of the MARS business at the supplier sites with respect to the quality and food safety of products and the food processing environment. This responsibility includes participation in the management of crises involving products, and the on-going interpretation and reporting of information from our customers and consumers, and the management of quality related document requests from the suppliers and/or customers
  • Assess food safety programs such as Hazard Analysis Critical Control Point Systems (HACCP), Good Manufacturing Practices (GMP), Sanitation, Food Defense, Pest Control and Continuous Improvement of the Quality Management Program through audits of the supplier sites in this segment
  • Lead the product related incident management process for licensing and strategic partnership sites, including affiliate customers. Manage decision, disposition and follow through processes with respect to non-conforming incidents impacting quality and food safety
  • Lead implementation of the Q&FS suite of standards to include specifically External Manufacturing Quality Management Standard
  • Manage and report on Quality and Food Safety metrics, including customer and consumer correspondence. Perform trend analysis to drive continuous improvement within the supplier sites
  • Participate with R&D during the development of the finished products. Complete supplier requested documentation and questionnaires. Lead finished product maintenance activities that include quality assurance tools such as raw material risk assessments, allergen assessments, technical specifications, etc
  • Bachelor’s Degree in chemistry, food science, microbiology or closely related scientific or technical disciplines
  • Advanced understanding of Good Manufacturing Practices (GMP's), Good Laboratory Practices (GLP's), Hazard Analysis Critical Control Point Systems (HACCP), FSSC 22000 or ISO 9000, Regulatory and Food Law Guidelines, Sensory, and Microbiology
  • Ability to travel 40% of the time
  • Experienced auditor and/or accreditation in GFSI Quality Systems such as SQF, BRC, FSSC 22000 or ISO 9000
33

Manager, External Manufacturing Resume Examples & Samples

  • Serve as the primary Regeneron technical contact for select DP contract manufacturing sites concerning day-to-day activities
  • Ability to travel up to 50% (domestic and international)
  • Manager requires a minimum of a BA/BS in any physical or biological science with 10+ years industry relevant experience, 9+ years with MS or 5+ years with PhD
34

Intern External Manufacturing Resume Examples & Samples

  • Proactively talk to key stakeholders to understand and map what processes and measures are in place today for supplier and alliance management and performance measurement
  • This includes gathering feedback from key stakeholders to understand what the weaknesses and strengths are of the current state. What data and measures are available today with current systems
  • Work with department staff to brainstorm possible solutions and future states for managing and measuring our business, that will ultimately be used for creating the future state
  • The output of the future state must be one that is sustainable, resilient, and able to grow with the company overtime
  • Creation of change process and steps to initiate creation of the future state
  • Work as a member of the external manufacturing team assisting in on going and day to day operations as needed
35

Director External Manufacturing Technical Operations Resume Examples & Samples

  • Is frequently present at the external partners site on the production floor, builds a strong interdependent relationship with his technical counterparts and is able to (“read a site”) assess & diagnose with appropriate tools and resource the true current condition & risks at a partners site and contributes to formulate in partnership with the external partner and the MSD cross-functional team action orientated and time bound improvement plans
  • Meets, as a member of the focused factory leadership team, with the external partner periodically for Business and Operations Review Meetings
  • Contributes, based on MSD and ExM strategy, to the development of the annual Hoshin Kanri Plan for the relationship with clear goals and targets
  • Leverages standard tools and best practices from the functional area
  • On an as need basis, engages the right subject matter experts in the MMD Manufacturing Science & Technology Community and MRL
  • Interfaces with up- and downstream internal and external sites to ensure end to end compliant, reliable and competitive supply
  • Minimum MSc in engineering, pharmaceutics or the life sciences
  • Minimum of 10 years manufacturing site experience in the areas of process start up, technical transfer, change control and root-cause analysis or have demonstrated experience in these areas
  • Minimum of 10 years of experience with projects involving tech support across the Internal / External Network
  • Strong business acumen, interpersonal and influencing skills
  • A quality, compliance, risk management and safety mindset
  • Flexibility and the ability to work collaboratively across cultures, functions, with External Partners and Internal sites
  • Technical skills in the areas of engineering, pharmaceutics and chemistry. Knowledge of spray drying considered a plus
  • Deep knowledge of the problem solving methodology, hands-on experience in leading complex investigations implying multiple root cause analysis work streams and ability in writing investigation reports and presenting/communicating investigational progress to the stakeholders and senior management. Black Belt qualification considered a plus
36

Manager External Manufacturing Make Resume Examples & Samples

  • Bachelor degree in Science, Engineering or commerce with equivalent technical experience
  • Min. 3 years experience in a regulated industry (OTC/Pharma)
  • Experience in a Production function (Production Management, Quality, Product engineering, R&D, SC...)
  • Ability to work in a matrix organisation and cross-functional environment
  • Demonstrated leadership / interpersonal skills
  • Good communication skills with ability to influence and negotiate
  • Knowledge of general manufacturing principles and practices as well as compliance requirements
37

Senior Manager, External Manufacturing Resume Examples & Samples

  • Independently oversees and leads daily interaction on quality matters with third parties and cross functional teams, including but not limited to the following
  • Generally, 10+ years of work experience in the pharmaceutical industry, (QA, QC and/or Compliance) is required to be successful in this position required
  • 5+ years of experience working with CMO and business partners required
  • 5-8 years of experience in working knowledge of GMP regulations and abilty to interpret and apply the GMPs and other regulatory requirements in the regulated environment required
  • 10+ years of experience in working knowledge of quality systems in the GMP, regulated industry and data analysis required
  • 5-8 years of experience in pharmaceutical principles, practices and their application preferred
  • 5-8 years of experience working / supporting a manufacturing environment for solid oral dosage products and/or experience with alternative dosage formulations and operations which includes but is not limited to: aseptic and sterile filling operations, semi solid and liquid dosage manufacturing, nasal sprays, patches, and/or drug/device combination products required
  • 2-5 years of experience in mathematical and statistical computations required
38

Senior Specialist, External Manufacturing Resume Examples & Samples

  • Minimum of five years of experience in the pharmaceutical industry with thorough knowledge of Quality Systems, Quality Assurance, and Quality Control including global GMP Quality Systems and regulatory requirements preferred
  • Strong knowledge of External Manufacturing management, supply chain, and operations
  • Lean Six Sigma / Merck Product ion Systems training
39

Director, External Manufacturing Sourcing Resume Examples & Samples

  • 5+ years of related experience
  • 5+ years of people management experience
  • A minimum of 5 years of Contract Manufacturing and Strategic Sourcing/Procurement experience
  • Project management experience and change management capabilities
  • Knowledge of continuous improvement tools (Lean, Six Sigma)
  • Broad-based understanding of business operations and practices and core Procurement areas of focus (Spend Management, Category Management, Sourcing and Supplier Management experience)
  • Strong leadership, communication, influencing and collaboration skills
  • Able to prioritize requests, and propose effective cost/customer service alternatives when necessary
  • Ability to show discernment in developing new approaches and resolving issues
  • Ability to show critical thinking
  • Strong project management skills
  • Strong business insight
  • General finance acumen
  • Good verbal and written communication skill with ability to confidently present complex information
  • Ability to continuously improve the organization and set strategy direction
  • The ability to collaborate effectively and drive alignment in a global environment is required
  • Ability to travel up to 25% international and domestic
40

Global External Manufacturing Finance Lead Resume Examples & Samples

  • Lead the planning and reporting activities and provide monthly consolidated results for Global External Manufacturing product P&Ls and inventory management for the Small Molecule, Biologics and Plasma Operation Units. This includes managing and developing a team of employees
  • Focus on refining global process standardization, automation, and improved decision support. Such as making recommendations for enhancement existing processes, and developing financial models and business case analysis used in supporting key decisions
  • Lead the budgeting, quarterly forecasting and long range planning exercises to support timelines communicated by Global Tech Ops Finance. Working closely with business partners to understand budget/ forecast requirements and provide overview and recommendations as necessary
  • Partner globally with Shire Finance Teams and Tech Ops Leadership by providing outstanding decision support and accounting / controlling leadership for the organization
41

Regional Manager Sourcing External Manufacturing Resume Examples & Samples

  • Guide the regional sourcing analysts in different strategic sourcing activities with a focus on performance and talent management, living organization values and overall management practices
  • Work in close collaboration with local Procurement Representatives (LPR's) in order to ensure local acceptance
  • Collaborate and align with global, regional, and local Procurement teams
42

Q&FS External Manufacturing Technologist Resume Examples & Samples

  • Responsible for 7 to 10 External Manufacturing locations (NA and Europe). Must be able to effectively manage the External Manufacturers remotely
  • Create an aligned/ harmonized QMS process for External Manufacturing in the Mars Fishcare Segment
  • Define the road map that will lead to full compliance to our global and regional standards
  • Qualify new external manufacturing locations against the global EMQM standard through preliminary, qualification, start-up and compliance audits
  • Define and drive the implementation of QMS as needed to ensure compliance to global EMQM standard
  • Design & deliver the appropriate training & awareness to EM associates and business unit for the standard and systems that are in place today or being develop in the future
  • Audits active External Manufacturers at least once per year per EMQM requirement
  • Provides support and direction to external manufacturing locations to drive continuous improvement of all quality systems
  • Govern that all products and packs produced at the External Manufacturers are safe and conform to the intended product design. Results recording, data review, data collection, trending of data. This includes being responsible for change management and process improvement
  • Supports the implementation of all new products, line extensions and continuous quality improvement projects including the effective execution of line trials and execution of process capability evaluations
  • Manage the effectiveness of the corrective and preventative action process within the framework of the Quality Management Program, External Manufacturing Quality Management
  • Initiate, manage and complete business level non-conformance/PRIMPS for all external manufacturing locations
  • Represent the "owners" of the Mars business at the site with respect to the quality and safety of products and the food processing environment. This responsibility includes participation in the management of crises involving products, and the on-going interpretation and reporting of information from our customers and consumers
  • Ensure adherence to the Mars Global Quality and Food Safety Standards including but not limited to HACCP, PRIMP, QMP, MQM and EMQM
  • HACCP and food safety management
  • FSSC 22200 Food safety schemes
  • Regulatory and food law including AAFCO Guidelines
  • Auditing
  • Statistics
  • Analytical chemistry, food microbiology, and sensory methods
  • Activity Management Process
  • Word, Excel, and PowerPoint
  • Pest Control Management
  • A minimum of 3 years of experience in a technical area such as R&D product development, laboratory management quality systems, or food process engineering
  • A BS degree in Chemistry, Food Science, Engineering, related technical field or equivalent experience
  • An advanced understanding of quality systems with an emphasis on Auditing of suppliers/vendors and food safety programs
  • Ability to travel 40% of time – including international travel
  • Advanced degree in Chemistry, Food Science, Engineering
  • 5 years of experience in a technical area such as R&D product development, laboratory management quality systems, or food process engineering
  • Lead Auditor Certification through a recognized Professional Organization
43

External Manufacturing Factory & Capacity Planning Resume Examples & Samples

  • Accountable for forecast sharing and capacity commit process with 3PF/Subcon
  • Identify and resolve short-term capacity disconnects (Execution Window Planning 0~3 months). Show leadership to get to results
  • Load to target management and/or resource under loadings. Drive optimal factory resource loading solutions
  • Demand variance analysis, WIP flush checking and tracking for critical resource/ products
  • Resolve disconnects and/or underloadings challenges
44

Associate Director, External Manufacturing Resume Examples & Samples

  • 1) Minimum 10 - 15 years of experience in biotech/pharmaceutical manufacturing industry with at least 2-4 years of responsibility for one or more external supply partners
  • 2) Proven ability to build alliance relationships with external partners
  • 3) Ability to communicate effectively, at all levels, within a highly matrixed organization
  • 4) Demonstrated project leadership skills and ability to develop effective working relationships with internal/external partners and cross-functional project teams
  • 5) Proven ability to manage complex projects
  • 6) Ability to lead change through projects at the site
  • 7) Influences change both internally and with the external partner