Manufacturing Lead Resume Samples

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S Stoltenberg

Sienna

Stoltenberg

26462 Green Pines

New York

+1 (555) 854 7396

26462 Green Pines

New York

Phone

p +1 (555) 854 7396

Experience Experience

New York, NY

Manufacturing Lead Technician

New York, NY

Purdy, Collins and Okuneva

New York, NY

Manufacturing Lead Technician

Recommend/Implement process changes/improvements or safety/ergonomic improvements
Assist supervisor/engineer/facilities with investigations
Initiate deviations or investigations of various complexities and work with cross-functional departments to identify root cause
Form and support various cross function teams designed to support continuous improvement measures
20% - People
70% Processing
70% - Processing

Phoenix, AZ

Otis Global ERP Manufacturing Lead

Phoenix, AZ

Beatty-Zboncak

Phoenix, AZ

Otis Global ERP Manufacturing Lead

Overseeing the project plan to ensure all parties are supporting the delivery plans for the build and the deployment sites
Providing approval and oversight for all changes into the mfg core model
Providing steering committee updates on program progress
Managing the multiple teams and schedules
Supervises project through all project phases and ensures adherence to project management methodology
Work with operations business team to ensure we are solutioning the right designs within JDE to support the business
Assigns project tasks and issues for resolution, including responsibility for task prioritization

present

Houston, TX

Manufacturing Lead-purification nd Shift Wed-sat

Houston, TX

Goyette LLC

present

Houston, TX

Manufacturing Lead-purification nd Shift Wed-sat

present

Recommend/Implement process changes/improvements of safety/ergonomic improvements
Provide timely feedback on staff’s performance
Create and follow-up on work orders
Ensure work is carried out in a safe manner, notifying management of safety issues and risks
Provide training
Ensure the use of safe work practices and behaviors
Develop training material

Education Education

Bachelor’s Degree in Life Sciences From

Georgetown University

Bachelor’s Degree in Life Sciences From

Skills Skills

Ability to manage, direct, and hold accountable various resources who could be working various shifts
Excellent documentation/data records ability
Ability to operate hand tools, power tools, and precision measuring instruments
High attention to detail and accuracy
Good interpersonal, communication, and time management skills
Excellent mechanical aptitude
Ability to actively participate in team development and team-oriented processes and motivate others to do the same
Ability to interpret technical data
Complete knowledge of all QA specifications as it relates to LQD
Ability to perform from oral or handwritten instructions

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15 Manufacturing Lead resume templates

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Manufacturing Lead Technician Resume Examples & Samples

Communicate/ coordinate days scheduling and staffing plan
Re-allocate staff as needed during the day (breaks, lunch, training, etc)
Responsible for floor inventory and communicating schedule changes as needed
Recommend/Implement process changes/improvements of safety/ergonomic improvements
Act as a role model (Lead by Example)
Act as a resource/SME for staff
Training
Help identify training needs
Assess staff skill sets and provide feedback to Supervisor
Initiate deviations or investigations of various complexities and work with cross-functional departments to identify root cause
Assist supervisor/engineer/facilities with investigations

Manufacturing Lead Technician Resume Examples & Samples

70% - Processing
Recommend/Implement process changes/improvements or safety/ergonomic improvements
20% - People
10% - Quality
Normally requires a high school diploma and 6+ years related industry experience or an Associates Degree in Life Sciences/Engineering field with 5 years of GMP Manufacturing experience
Biotech Certificate and prior leadership experience preferred
Experience with systems such as SAP, LIMS and TrackWise is a plus

External Manufacturing Lead Resume Examples & Samples

Manage clinical drug product operations, including scheduling, finances, and document review/approval, and maintenance of relevant quality systems
Manage cross functional technology transfer teams for implementation of drug product processes at contract manufacturing facilities
Develop and maintain relationships with external partners
Represent drug product manufacturing on cross functional project teams
Provide person in plant oversight for critical drug product fills
Author and review drug product manufacturing sections of regulatory submissions
Minimum BS degree in engineering, chemistry, biotechnology, or related science
Minimum 3-5 years experience in development, operations and/or quality in pharmaceutical industry
Thorough knowledge of global GMP regulations and guidance
Aseptic fill operations experience in the pharmaceutical/biologics field
Experience within a project team (preferably involving external partners)
Strong communication, presentation and analytical skills

Manufacturing Lead Technician Resume Examples & Samples

Oversight and execution of all routine and critical operations as well as
Biotech Certificate and prior leadership experience preferred. Experience with systems such as SAP, LIMS and TrackWise is a plus
Operational knowledge of Clean-in-Place (CIP) and Steam-in-place (SIP) Systems and general production equipment such as Autoclaves, water baths, pH/Conductivity meters etc
Expected to act on behalf of the supervisor while on the floor
Flexibility to work according to the production schedule. This position will require weekend, holiday and overtime work at times
Ability to lift, pull or push equipment requiring up to 25-50 lbs of force
Stooping or bending to check or trouble-shoot equipment operations

Manufacturing Lead-protein Purification st Shift Wed-sat Resume Examples & Samples

70% Processing
Create and follow-up on work orders
Responsible for interviewing candidates
Provide timely feedback on staff’s performance
Ensure the use of safe work practices and behaviors
Revise and author Standard Operating Procedures/Batch Records

Manufacturing Lead-purification nd Shift Wed-sat Resume Examples & Samples

Oversight and execution of all routine and critical operations as well as commissioning and validation activities
Ensure documentation is complete, reviewed and meets good documentation practices (forms, logbooks, form preps, batch records, etc.)
Address minor personnel issues timely
Ensure staff compliance with all relevant SOPs, BR, FP and safety guidelines
Conduct training and assess effectiveness
Develop training material
10% Quality
Complete action items for GMP investigations and CAPA’s
Communicate any quality issues/concerns to Supervisor and QA

Quality & Manufacturing Lead Resume Examples & Samples

Perform factory surveillance and manufacturing support for launch vehicle certification. Verify/validate that LV contractor is tracking and resolving those issues, nonconformances, and corrective actions. Enter assessments, evaluations, analyses, issues, findings, observations, opportunities for improvement in the report formats requested he Government
Document and track findings along with their root causes and corrective actions in a spreadsheet format, and vet the acceptance and ensure the consolidation of the corrective actions into ULA's corrective action system/database
Identify and assess product design and manufacturing processes requirements for the manufacturing baseline including special tooling, process proofing (qualifications), standards, methods, procedures, metrics, and data
Assess LV contractor implementation of industry standards in the process for manufacturing and management
Verify/validate the "as-built" configuration of the major components being shipped (e.g. Booster Assembly, Upper Stage Assembly, and Avionics Tower) against the ABCL (As-Built Configuration List)for LV certification
Experience applying modern manufacturing principles and methods including: quality management system standards, product and process controls, measurement and test, audits, statistical applications, corrective and preventative action, and lean manufacturing
Willingness to travel on extended TDYs to other work sites

Manufacturing Lead-nights Resume Examples & Samples

Leadership experience required; manufacturing experience preferred
Good communication, teaching and interpersonal skills
Intermediate math skills

Production / Manufacturing Lead Resume Examples & Samples

1 - Creating detailed production plans, developing and maintaining work orders for their assigned IPTs throughout the product life cycle
2 - Creating production assembly sequences and integration for assembly, installation, modification, repair or refurbishment of development and flight hardware based off available engineering documentation
3 - Working with the LOB Production, ATLO and MPS team in the establishment and maintenance of break points, product structure and ALMs
Ability to analyze manufacturing schedules, identify issues impacting manufacturing velocity and offer suggestion(s) for maintaining delivery commitments both internally and externally
Candidate must be able to develop/maintain and status manufacturing bills of materials, identify material shortages and identify alternate approved materials
Candidate must have functional knowledge of MS Word, Excel, PowerPoint
Candidate must have a minimum of 1 year of demonstrated experience using SAP or another ERP system generating work instructions, routings, product structure and engineering/manufacturing bills of materials
Candidate shall have experience reviewing and interpreting technical writings and engineering drawings including the appropriate use of GD&T
Ability to write technical reports and keep accurate documentation including formal presentations
Possess knowledge of SAP/VE CAMS System
Detailed knowledge of Manufacturing Resource Planning and Enterprise Resource Planning
Special tooling and handling knowledge. Design for Manufacturing and Assembly (DFMA) and Design to Cost tool-set
Exposure or participation on teams that have performed product, facility and/or resource risk mitigation through in-depth usage of Producibility techniques
Candidate shall have experience with configuration management practices and databases such as Windchill, EPDM or similar
Ability to perform requirement analysis in either an electrical, mechanical or RF system. -
Experience working within either the Production or ATLO organizations
Demonstrated experience working within a major assembly and/or test team
Ability to drive process development, cost reduction and/or product development to delivery in a cross functional team

Manufacturing Lead Bulk Operator Resume Examples & Samples

Lead and assign daily tasks and operations related to Bulk manufacturing or Filling and Inspection to meet the production Schedule
Manufacturing representative for area in scheduling. Work closely with all support departments and other manufacturing leads on scheduling and issue resolution. Prepare shift hand over sheets as appropriate
Be an active contributor to the departmental staff meetings by occasionally serving as a facilitator
Ensure all EH&S policies, procedures and guidelines are maintained and training is complete for staff
Demonstrated organizational and leadership skills required to coordinate and lead manufacturing team in daily activities to meet the production schedule
Experience in GMP manufacturing
Must understand and be proficient with basic arithmetic calculations, including calculating elapsed time and ratio calculations

Lead Manufacturing Lead Technician Resume Examples & Samples

Perform and participate in the management of complex manufacturing tasks
May perform supervisory functions for manufacturing processes from receipt of unprocessed blood through shipment of finished goods
Actively participate in problem solving and on cross-functional teams

Manufacturing Lead Resume Examples & Samples

Operates filling and packaging equipment for the manufacturing of drug product
Completes all documentation accurately (review batch records/ERPLx transactions)
Performs initial and ongoing training and development of associates

Manufacturing Lead, Comfort Bath St-br-en Resume Examples & Samples

Accept direction
Demonstrate a commitment to learning
Able to work constructively and independently
Display a high level of personal integrity and self-control
Accept constructive criticism
Interact effectively and cooperatively with others
Establish clear objectives and continuously work towards meeting them
Positively influence others without direct authority
Transfer acquired knowledge, ideas and concepts onto others successfully
Develop effective relationships throughout the organization
Communicate effectively using different forms of communication
Rely extensively on experience and judgment to plan and accomplish goals

Otis Global ERP Manufacturing Lead Resume Examples & Samples

Overseeing the project plan to ensure all parties are supporting the delivery plans for the build and the deployment sites
Work with operations business team to ensure we are solutioning the right designs within JDE to support the business
Providing approval and oversight for all changes into the mfg core model
Managing the multiple teams and schedules
Providing steering committee updates on program progress
Manages overall program schedule, budget and delivery
Ensures alignment to company strategy
Supervises project through all project phases and ensures adherence to project management methodology
Responsible for project setup, incl. project organization, roles and responsibilities, project plan and project schedule
Proposes and aligns project objectives and project approaches with business project sponsors and other stakeholders
Ensures that delivered solution meets project objectives
Manages project dependencies, risks and issues
Manages suppliers delivering program components and coordinates closely with supplier delivery and project management
Negotiates and coordinates project resources for successful project delivery
Leads project team through all phases of the project, directly manages work stream leaders
Assigns project tasks and issues for resolution, including responsibility for task prioritization
Establishes efficient project controls and change management approaches
Leads program / project meetings with work stream leaders
In cooperation with supplier project manager brings decisions, which cannot be made by project team to the project / program steering committee and proposes / recommends alternatives on behalf of the project team
Reviews vendor contracts
Approves time cards and invoices, maintains overall project / program budget and actual spend overview
Coordinates cross-functional project resources
Coordinates with PMO, solution build and deployment leads
Ensures project compliancy with company policies and passport / SDLC process
Active role in program change management
Proven management experience in supporting JDE Manufacturing projects
Experience with working with outsourced teams (onshore/offshore, internal and external resources, and multiple partner vendors)
Minimum of 8 years’ experience in managing large projects either from an IT or business perspective
Strong program management
Excellent verbal and written communication skills. Able to conduct presentations to large organizations, as well as to executive and upper management teams
Knowledge of J.D.Edwards ERP software is a plus
Strong organizational, multi-tasking, and time-management skills
Ability to resolve project conflicts
Team leadership skills
Business judgment and ability to develop project delivery strategy
Experience with complex manufacturing programs
Overall cross-functional knowledge in areas of manufacturing, procurement, sales, quality management, product data management, product configuration, systems implementation and integration -> ability to efficiently address functional topics with functional and technical subject matter expert

Manufacturing Lead Operator Resume Examples & Samples

Oversee training and adherence to standard operating procedures (SOPs). Maintain a “Right the First Time” operation
Remain fully trained in the execution of all aspects of area of responsibility
Lead resources responsible for the authoring, drafting and revising of departmental procedures and practices
Interact with outside vendors including the outside cleaning service
Serve as a point of contact for operational/equipment issues
5 years of relevant pharmaceutical industry experience
Must be able to effectively communicate, with peers and vendors
Must have good attention to detail and documentation skills

Manufacturing Lead Resume Examples & Samples

Planning and reviewing the department activities and oversee processes
Review and use the system tools to monitor the incoming sales orders
Review sales orders, check shortages and connect with Sales and Purchasing teams
Oversee and control the area to ensure a safe and clean environment
Assist with inventory control and documentation
Work with upper management effectively to execute the policies and goals of the organization
Perform related duties as assigned by the Vice President of Operations
Frequent lifting up to 30 lbs
2 years: Material Expediting
2-5 years: Sales

Manufacturing Lead-dispensing Resume Examples & Samples

Assign daily tasks to Dispensing technicians
Document daily productivity
Load dispensed material into assigned blenders and mix in conjunction with Batch Production Records (BPRs)
Discharge material from blenders into appropriate containers
Weigh blended material and document appropriately
Conduct training for Dispensing and Blending Technicians
Communicate with management on a regular basic
Minimum two years of Dispensing and Blending experience or equivalent
Ability to identify and assist team members and other departments as needed

Oracle EBS Manufacturing Lead Resume Examples & Samples

Oracle EBS Manufacturing Lead, responsible for implementing one or more modules - Purchasing, Procurement, Inventory, Cost, Work in Process, Quality, Bills of Material, Advanced Supply Chain Planning (ASCP)
Leading functional workshops educating customers on the product
Develop future process flows and requirements
Guide and conduct unit testing and comprehensive testing
Work with technical resources on data conversions and custom form and reports
Conduct end user training and development of training materials
Architecting functional solutions for various projects
Participate as a functional lead on supply chain & manufacturing projects as well as work remotely in a customer support capacity as required

Downstream Manufacturing Lead Resume Examples & Samples

Under the supervision of department director, lead purification and downstream manufacturing operations for Phase I and Phase II GMP Manufacturing
Contributions to the team will include the following: prepare buffers, sample in-process materials, formulate bulk drug substances, conduct changeover and activation procedures for clean room (including equipment), submit in-process and cleaning samples to Quality Control, and complete Batch Production Records (BPR) pursuant to cGMP
Work closely with process development to transfer projects from PD to Manufacturing

Manufacturing Lead Resume Examples & Samples

Manage incoming material shipments to ensure accuracy, completeness, and conditions of shipments. Manages receiving process into computer system
Confirm all incoming materials, examining product for and reporting any current or potential issues
Direct movement of various materials to appropriate areas
Prioritize tasks to meet inventory and shipping needs
Assist in determine and documenting work procedures, preparing work schedules and expediting workflow
Provide direction, leadership, and counseling to employees in coordination with company policies
Work with employees to evaluate and develop employee’s skills
Manage in-line and or special quality assurance activities / testing product to ensure quality standards are being maintained
Provide feedback on process or quality issues to the appropriate level of management
Managing packaging of product per customer specifications
Ability to manage, direct, and hold accountable various resources who could be working various shifts
Ability to actively participate in team development and team-oriented processes and motivate others to do the same
Problem solving, system and methods improvement skills
Good interpersonal, communication, and time management skills
Excellent mechanical aptitude
Excellent documentation/data records ability
Ability to interpret technical data
Ability to operate hand tools, power tools, and precision measuring instruments
Ability to perform from oral or handwritten instructions
Ability to read, write and understand English
Physical capabilities include sitting, standing, walking, talking, and hearing, bending, pushing, pulling, and lifting up to 50 lbs

Electronic Manufacturing Lead Technician Resume Examples & Samples

Preserving our environment through sustainable manufacturing practices
Detail oriented and accurate
Able and willing to cross train and master electronic assembly as well as preparation skills
Ability to read and follow assembly instructions and visual aids
Ability to read and adhere to IPC-A-610
Solder wires and electronic components
Manipulate, handle, and assemble small components
Data entry
Material handling & setup
Time keeping for operators
Responsible for daily activities for all manufacturing operators
Investigative and problem solving skills
BOM and routing knowledge
ESD practices and policies
GMP (Good Manufacturing Practice’s)
IPC-A-610 Inspection Criteria
EPA (Environmental Protection Agency) knowledge
Education – Associates or Technical degree in a related field or equivalent
Experience - Minimum 5 years of proven success as an electronics manufacturing operator or Team Lead. Additional experience may be substituted for education and vice versa

Manufacturing Lead Technician Resume Examples & Samples

Serve as primary reviewer for all in-process documentation as well as the point of contact for all issue resolution
Document and approve product and process discrepancies utilizing the TRACKWISE System
Schedule and perform routine and advanced duties that are required to maintain the production facilities
Participate and remain current in all departmental medium qualification requirements
Form and support various cross function teams designed to support continuous improvement measures
Lead facility inspection preparation and readiness for regulatory and partner audits
BS degree in life sciences from an accredited college or university or equivalent experience
The ability and willingness to work as a team player and possess good interpersonal skills
Demonstrated experience in manufacturing processes and equipment such as CIP, SIP, aseptic filling lines, HMI
Excellent written and oral English communication skills

Secure OT / Energy & Manufacturing Lead Resume Examples & Samples

10 years of experience with operational technology
2 years of experience with project and engineering manager, including hiring and forming teams of technical and engineering talent and oversight and quality assurance of technical delivery
2 years of experience with writing technical proposals
2 years of experience with negotiating scope, pricing, and requirements for technical contracts
2 years of experience with conducting hardware and system design for SCADA and ICS systems or technologies
2 years of experience with managing financials for a technical project in excess of $500K
Ability to lead multiple geographically distributed staff across commercial and government clients
BA or BS degree
5 years of experience with project and engineering manager, including hiring and forming teams of technical and engineering talent and oversight and quality assurance of technical delivery
5 years of experience with writing technical proposals
5 years of experience with negotiating scope, pricing, and requirements for technical contracts
5 years of experience with conducting hardware and system design for SCADA and ICS systems or technologies
5 years of experience with managing financials for a technical project in excess of $500K
Experience in a manufacturing and energy company or as a Product Vendor (OEM) to these sectors
TS/SCI clearance
BA or BS degree in an engineering or technical field preferred; MA or MS degree in Business a plus
Certified Project Management Professional (PMP) Certification

External Manufacturing Lead Resume Examples & Samples

Principal Accountabilities
Effectively communicate and manage EMQM holds, and product non-conformances
Drives efficiency with consumer contact reporting by keeping track of CCI’s, following up with EM’s on status, closure, and reporting back to BU

SAP Manufacturing Lead Resume Examples & Samples

Develop a global Enterprise Resource Planning, "Plan to Manufacture” systems design plan and configure solution to enable corporate strategic objective and drive business value
Develop, lead, and deliver on promise the Enterprise Resource Planning "Plan to Manufacture” Execution globally to include integrations to other modules globally
Design and deploy a global Enterprise Resource Planning organization that includes internal Information Technology, Business, and external partner resources
Design and deploy Organization Change Management (OCM) structure, process, and Tools working closely with Human Resources and Enterprise Resource Planning leader
Manage the budget, spend, schedule, and quality delivery (manage Scope) to deliver on promise using strong Project Management Skills and team members
Bachelor's or Master's degree in Supply Chain, Manufacturing, Business Administration or related field
Minimum 10 years' experience in Global Enterprise Resource Planning Supply Chain implementations, SAP highly desirable
Proven experience in an Enterprise leadership role and previous responsibility for functional and technical guidance over the whole project lifecycle
Strong Leadership and skills in deployment of SAP Plan to Manufacture (P2M) modules to global manufacturing companies
Excellent Organizational Change Management skills and evidence of results in deploying Enterprise Resource Planning successfully for large companies
Demonstrated ability to manage and resolve conflicts and priorities
Inherent adaptability regardless of the complexity or variability of a situation, employs maxims for guidance with meanings that adapt continuously
Proven experience developing training content and working with Organizational Change Management regional team leads to assess User Change Impact
10 years' experience in SAP Plan to Manufacture modules and integration experience and hands-on configuration experience in most Plan to Manufacture modules. Specific implementation experience with SAP Supply Chain Management execution as well as the following functions
Highly desirable certifications include: Certified in Production and Inventory Management (CPIM) and SAP Plan to Manufacture modules
Full Life Cycle SAP Procure to Pay implementation experience
Strong Leadership and SAP skills in deployment of Procure to Pay to global manufacturing companies
Prior experience with SAP Engineer to Order / Make to Order using Variant configurator is a strong plus for this role
Specific implementation experience with SAP Supply Chain Manufacturing execution as well as the following functions: Production Planning; Quality Management; Plant Maintenance; Manufacturing Execution System (MES); Internet of Things (IOT); Environment, Health and Safety; Extended Warehouse Management (EWM); Manufacturing Integration and Intelligence (SAP MII); Advanced Planning and Optimization (SAP APO); Production Planning and Detailed Scheduling (PP/DS) for Manufacturing. Excellent knowledge on SAP Manufacturing integration to Finance and Material Management modules is a plus
Multi-language skills are a plus

Manufacturing Lead Liquid Paint st Shift Resume Examples & Samples

Must provide effective supervision of subordinates to achieve desired results. Attributes necessary to meet this need may include communications, motivation, team building, employee involvement, diplomacy, delegating, etc. skills as well as confidence and enthusiasm
Position requires occasional exercise of decision making, problem solving, policy or procedure compliance and facilitation skills
Generally, will supervise department (s)/ area(s) where work performed is of an unskilled to semi-skilled to skilled nature, and/or where a variety of occupational skills may be employed
May generally supervise 7 to 15 employees
Keeps supervisor informed of all pertinent information and developments
Position requires ability to work in a normal production plant environment
Inventory monitoring
Operate cell equipment
Supplementary assistance to line operators
Training of employees in operation of various cell equipment as needed in operation setup and trainer level proficiency
Support to cell manager in areas of production: scheduling, manpower planning and vacation planning
Take on projects and assignments as assigned by supervisor
Set up material for next shift
Taking care of time cards when Supervisor is on vacation
Trained in First Aid and/or willingness to be First Aid Trained

Manufacturing Lead Resume Examples & Samples

70% Direct accountability for the results of the plant operations, including, but not limited to: personnel, safety, quality, housekeeping, maintenance, customer service and costs in the region
Oversee and make decisions for OEE, Model Mill approvals, accident investigation reporting, plant staffing
Act as key advisor on base/non base capital spending
Ensure government regulation compliance, etc
Partner with the CFN Operations Director in development and deployment of strategies in the plant operations arena
Act as expert advisor to Plant Managers in processes and programs
Input for new business development and acquisitions/right sizing
Leadership on World Class level attainment for the plant and region
10 % Operation Tag for Commercial/SMT leadership team
Will align KRA’s to meet growth and AOE targets
20% Talent Management and Development
Provide regular and timely coaching to team members
Motivate for high performance and excellence
Provide an environment that supports personal growth and development for regional operations employees
Bachelor’s degree in business, operations, or other related field or equivalent commensurate experience
Minimum of 10 years progressive experience in successful plant management operations with multiple locations
Ability to solve complex problems through innovation, collaboration, creativity and determination
Demonstrated experience in all areas of production operations including quality control, construction, logistics and production
Excellent leadership, communication, collaboration, and time management skills
Experience in working in a matrix organization and multinational company/international environment
Fluent English, Romanian and/or Hungarian
Experience in the agricultural or feed industry, or food industry
Knowledge of food safety requirements

Clinical Manufacturing Lead Resume Examples & Samples

Operations: Manages manufacturing activities, including the preparation and close out of batch records; Ensures the batch record documentation is executed with minimal errors; Starts and completes manufacturing activities on time, according to the established schedule
Formulation Development: supports and collaborates on formulation development and research activities occurring in the pilot plant
Technical Support: Provides meaningful assistance with trouble-shooting and identifies solutions to issues that arise during manufacturing; Supports product development and technology improvement activities; actively participates in functional area improvement initiatives
Compliance: Follows cGMP requirements, established policies, procedures and practices; Conducts business activities needing minimal deviations or exceptions; Follows established safety requirements, reports incidents/near misses and recommends improvements
Project Coordination: Works with the CMC team and other supporting areas to assure project commitments are met, for example, providing draft batch records for review, assuring material availability, preparing cleaning documentation and completing inventory transactions
Communication: Records, tabulates and reports results within the group or team using the necessary tools (Reports, memos, presentations, spreadsheets, notebooks, etc.); Reports significant issues to management with appropriate sense of urgency; Attends group and project meetings, being prepared to communicates concerns and participate in discussions
Leadership: Coordinate activities of manufacturing technicians in a matrix environment

Manufacturing Lead-flexbumin Resume Examples & Samples

Ensure products are provided to customers on time so that product quality, yield, operating costs, and process efficiencies are met
Identify/prioritize/provide resources to meet the annual operating plan and budgetary commitments
Manage the daily manufacturing operations across the department on multiple shifts through subordinates
Ensure proper training of all staff that is part of the production process
Drive improvements in the area to reduce safety risks, improve product quality, eliminate production discrepancies, and reduce operating costs
Manages overall coaching, training, development and succession plans for his or her team
Interfaces with other groups, locally and globally, to ensure the department is successful
Prepare and follow documented budget plans
Relentlessly drive a high GMP and safety operating standard that is compliant with all applicable regulatory bodies: FDA, EMA, Chinese FDA, OSHA, etc
Adheres to all applicable procedures and policies
Perform analytical review of data to recommend and implement corrective actions to improve the area of operations
Support plant wide strategic plans and activities
Ability to manage activities of department through subordinates
Ability to drive safety, quality, cost, and production initiatives through a large multi-shift organization
Ability to interpret and analyze statistical data and information
Ability to work in a highly automated production environment
Ability to interface with support groups such as engineering and technical services to drive alignment on priorities to produce effective results
Working knowledge of world class pharmaceutical manufacturing methods such a Lean Manufacturing, Six Sigma, cGMP, and CFR guidelines
Ability to organize and present technical issues without assistance
Ability to understand validation packages and regulatory licenses
Bachelor degree in Science or Engineering required. 8-10 years of relevant experience.