Drug Product Resume Samples
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Drug Product Resume Samples
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GA
G Abbott
Gus
Abbott
30170 Auer Light
Los Angeles
CA
+1 (555) 632 6396
30170 Auer Light
Los Angeles
CA
Phone
p
+1 (555) 632 6396
Experience
Experience
Los Angeles, CA
Manager, Drug Product Inspection
Los Angeles, CA
Watsica Inc
Los Angeles, CA
Manager, Drug Product Inspection
- Manages and facilitates interactions and communications with internal and external client stakeholders regarding production
- Manages exempt and non-exempt Drug Product Inspection, Labeling and Packaging employees
- Analyzes data and results and provides conclusions and proposals
- Responsible for group metrics, analyzing results and presenting conclusions to Senior Management
- Researches and implements new methods and technologies to enhance operations. Suggests improvements to existing methods and procedures
- Writes/executes inspection protocols, SOPs, forms, and study reports
- Employs high level technical expertise to develop new processes and creatively solve problems
Chicago, IL
Director, Drug Product Business Development
Chicago, IL
Parker Inc
Chicago, IL
Director, Drug Product Business Development
- Manages sites for key accounts in their area of geographic responsibility
- Responsible for business development for all accounts in geographic responsibility
- Responsible for working with key account managers (KAMs) in other businesses to share data and manage a consistent face of Wuxi to the key account
- Responsible for analytical and formulation sales in his/her geography
- Responsible to grow revenue and build relationships in his/her geography
- Responsible for creating and sustaining a steady pipeline of business to ensure increasing year to year revenue growth
- Develops strategies to penetrate late-stage formulation and analytical development areas
present
New York, NY
Senior Principal Engineer Drug Product TS
New York, NY
Dietrich-Okuneva
present
New York, NY
Senior Principal Engineer Drug Product TS
present
- Assist the Global Pharmaceutical Sciences group with technology selection, process design, development and optimization
- Process design, development, optimization and verification
- Design, develop and optimize product manufacturing processes using robust DoE and QbD principles
- Continuous improvement
- Develops, maintains and acts on comprehensive risk register for their product process
- Building and maintaining a network of robust relationships with Regulators, Suppliers, CMOs, OEMs and Key Opinion Leaders in their respective technical field
- Facilitate communication between the departments, including meetings facilitation, progress tracking, and updates to supply chain leadership
Education
Education
Bachelor’s Degree in Engineering
Bachelor’s Degree in Engineering
Kaplan University
Bachelor’s Degree in Engineering
Skills
Skills
- Experience with database and data standards/terminology in Healthcare Information Technology (HIT) industry such as clinical knowledge, drug information systems and clinical decision support databases
- Knowledgeable of Elsevier products including CPi, GSDD, Clinical Pharmacology, etc
- Ability to work collaboratively with the Drug Product team and other Elsevier cross-functional teams
- Proficient with Microsoft Office programs including but not limited to Word, Excel, Access, PowerPoint, Project, Visio and Outlook
- Knowledge and experience using SQL server
- Experience on how drugs are aggregated for analytical purposes
- Experience querying, analyzing and manipulating data from databases or other data related sources
- Experience or familiarity with commercial drug databases and their applications
15 Drug Product resume templates
Read our complete resume writing guides
1
Principal Drug Product Dev Engineer Resume Examples & Samples
- Provide technical support leadership for deviations, change controls, and GMP investigations for global clinical drug product manufacturing
- Author/review manufacturing documents and support regulatory submissions, responses and inspections
- Identify and manage process improvement activities for existing clinical manufacturing operations
- Represent within cross functional project teams including development CMC teams
- Provide Department-wide operations support including establishing more effective systems and processes, technical evaluation of new technologies and contract partners, budget management, and resource prioritization
- Minimum, M.S. degree in engineering, chemistry, or related science
- Demonstrable, proven experience in pharmaceutical development and manufacturing
- Experience with pharmaceutical development and aseptic manufacturing operations for injectable pharmaceuticals and biologics
- Thorough knowledge of global GMP regulations and guidance
- Experience with statistical data analysis preferred
2
Drug Product Data Business Analyst Resume Examples & Samples
- Ensure drug product data integrity, accuracy, and completeness within the Gold Standard Drug Database (GSDD)
- Lead approvers in the addition, review, and approval of drug product data edits entered or updated within GSDD
- Manage projects from inception to completion
- Work with the Elsevier Technology Services (ETS) to implement/test GSDD enhancements
- Provide drug product data knowledge to ETS and other business units to triage issues within the drug product data and/or GSDD hierarchy concepts
- Assist with Quality Assurance (QA) of enhancements made to GSDD and drug product data and perform QA as assigned for existing data
- Work with pertinent staff in the creation of Business and Functional Requirements documentation
- Work with Drug Product Team members to design, implement and test enhancements for the Product Editorial Tool (PET)
- Utilize SQL and/or MS Access to extract data from multiple databases for internal and external analysis
- Provide ad-hoc reports, including creating and generating queries for analysis and interpreting results and trends in the data
- Work with Customer Support and Implementation staff to provide data aggregation for existing and potential customers
- Work with Drug Product Team members to document processes
- Manage drug classifications and indications for MedAlternative product
- Perform User Acceptance Testing (UAT) for new releases as needed
- Other duties or tasks as assigned
- Bachelor’s Degree in healthcare administration, health sciences, informatics (Pharmacy, Nursing or any other related health discipline) or information technology
- Minimum 3-5 years of pharmacy experience preferably in a retail, hospital or other healthcare related setting
- 3-5 years of informatics experience (healthcare or pharmacy preferred)
- Proficient with Microsoft Office programs including but not limited to Word, Excel, Access, PowerPoint, Project, Visio and Outlook
- Experience or familiarity with commercial drug databases and their applications
- Knowledgeable of Elsevier products including CPi, GSDD, Clinical Pharmacology, etc
- Experience on how drugs are aggregated for analytical purposes
- Knowledge and experience using SQL server
- Experience with database and data standards/terminology in Healthcare Information Technology (HIT) industry such as clinical knowledge, drug information systems and clinical decision support databases
- Experience querying, analyzing and manipulating data from databases or other data related sources
- Ability to work collaboratively with the Drug Product team and other Elsevier cross-functional teams
3
Principal Drug Product Scientist Resume Examples & Samples
- Provide technical leadership for formulation and drug product development activities including life cycle management projects. Design and execute experiments when needed
- Lead and represent drug product development in cross-function project teams, organizational initiatives and technology development groups
- Author/review protocols, reports, manuscripts and pharmaceutical development and other related CMC sections in regulatory submissions
- Identify, evaluate, adopt and develop formulation and drug product technologies to continuously improve business processes and product development capabilities
- Advanced degree in chemistry, biochemistry, pharmaceutical sciences, chemical engineering or related field
- Minimum of 7 years of industrial experiences in biopharmaceutical development setting
4
Principal Drug Product MS&T Scientist Resume Examples & Samples
- Provide technical leadership for drug product development and tech transfer activities for life cycle management projects
- Provide technical support for deviations, change controls, and GMP investigations for global commercial drug product manufacturing
- Author/review technical documents and support regulatory submissions, responses and inspections
- Identify and manage product/process improvement activities for commercial drug products
- Represent within cross functional project teams including CMC and tech transfer teams
- Provide Department-wide operations support for system/process improvement, evaluation of new
- Ph.D. degree in pharmaceutical chemistry, chemistry, engineering or related disciplines
- Minimum, 10 years’ experience in pharmaceutical development and manufacturing
- Experience with the development and manufacturing of sterile Drug Products, preferably relating to aseptic manufacturing processes for injectable pharmaceuticals and biologics
- In-depth knowledge of global GMPs and regulatory requirements for product registration
- Experience with statistical experimental design and data analysis preferred
5
Principal Drug Product MS&T Scientist Resume Examples & Samples
- Author/review manufacturing documents and support regulatory submissions, responses and inspections – 20%
- Provide Department-wide operations support including establishing more effective systems and processes, technical evaluation of new technologies and contract partners, budget management, and resource prioritization - 10%
- Minimum, 10 years experience in drug product development and manufacturing
- Experience with aseptic manufacturing operations for injectable pharmaceuticals and biologics
- Experience with statistical data analysis preferred
6
Scientist Drug Product Mfg Sci & Tech Resume Examples & Samples
- 25% Support drug product related activities to achieve the project goals
- 25% Perform data analysis for continuous process improvements and life cycle initiatives, aimed at improving drug product manufacturing process robustness and consistency. Provide technical expertise and support to improve manufacturing process through life-cycle management
- 10% Provide sound technical and scientific support within cross functional project teams including CMC, quality investigation and process improvement
7
Senior Drug Product Lead Resume Examples & Samples
- We rely on your scientific/technical expertise to develop robust formulations and processes, supporting successful production of preclinical toxicology material and process transfers to GMP manufacturing as well as to provide the required technical documentation for worldwide CTA registration
- To meet these deliverables, you adhere to timelines and quality requirements and are responsible for the direct oversight of interfaces
- The successful candidate will lead and manage all pharmaceutical drug product development activities for assigned projects within the Biologics Early Phase Development (EPD) Unit, lead and co-ordinate the drug product team (functional experts) and represent Pharmaceutical Development on the global CMC team
- You will be working in multidisciplinary and international teams, reporting scientific/technical results internally (including patents) and representing Novartis externally at meetings, giving talks, being part of industry consortiums, publishing papers
- As senior drug product lead you will also be responsible for key strategic initiatives within the Pharmaceutical development team- The development of new technologies and supervision of scientific projects and external collaborations are further options within this position
- Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant project team member(s)
- Interpret results, evaluate data, draw relevant conclusions, write reports
- Generate scientific documents to hand over to internal partners (GMP manufacturing plants, Device Development, Regulatory CMC, Clinics etc.). Actively support generation of international registration documents
8
QA Specialist, Drug Product Manufacturing Resume Examples & Samples
- Provides oversight to continuous quality system improvements and supports implementing improvements at CMO's in compliance, Preventive Maintenance, Deviation Management and Change Control Programs as they impact Alexion
- Works closely to build relationships with contract manufacturers quality personnel
- Works closely with internal cross-functional impacted areas, such as CMO Management, CMC/Regulatory Affairs, and QA, to resolve open issues in a timely manner resulting from record reviews and deviation events
- Responsible for reviewing contractor documents to ensure that they comply with Alexion procedures and meet Alexion standards
- Approve Alexion specific standard operating procedures and controlled documents issued by contract manufacturing organisations
- Support contract manufacturing organisation audits, including pre-approval inspections, as necessary
- Reviews and assesses deviations; includes performing risk assessments, participating in root cause analysis investigations, tracking, follow-up and reporting/trending
- Must have direct experience of drug product manufacturing processes in a cGMP environment
- Must have detailed knowledge of industry best practice and current regulatory expectations concerning drug substance manufacturing. Minimum of 10-12 years' GMP related experience in biopharmaceutical / pharmaceutical or related industry
- Excellent written and verbal communication and negotiating skills
- Ability to exercise judgment with defined procedures and practices to determine appropriate action
- Ability to prioritize daily activities in order to meet internal and external customer needs on time of established timelines in a fast-paced environment
9
Manager, Plant Quality Assurance Drug Product Resume Examples & Samples
- Plans and manages the work of the BI Fremont Plant Quality Assurance group; contributes to department mission statements; and provides technical leadership to ensure all necessary quality checks are completed on time, and according to SOPs
- Identifies deviations from SOPs in manufacturing operations; records and reports issues to appropriate parties; recommends corrective action and follows up to ensure resolution
- Optimizes allocated department resources
- Ensures optimal Plant QA oversight during swing shift MFG operations including on-the-floor batch record review, PQA walkthroughs, triage of issues on the floor, etc
- Identifies, classifies and reports deviations, as appropriate and works on more complex deviations. Oversees execution of remediation/CAPA activities required to continue production or move a process to the next milestone. Works closely with cross functional team members to determine root cause and potential preventative/corrective actions
- Ensures support for the timely closure of investigations. Authorized to suspend any operation when the situation warrants
- Provides guidance and control directives regarding remediation activities required to continue production. Is required to escalate critical issues within area assigned to senior management team based on severity of the issue
- Prepares for, manages and coordinates internal/customer audits and regulatory audits including
10
Engineer, Drug Product Process Development Resume Examples & Samples
- Background in pharmaceutical development as it relates to formulation development and process development/optimization
- Experience in scale-up and technology transfer, moving from laboratory to pilot plant and production scale
- Experience across various solid oral dosage conventional and enabling manufacturing technologies is desired
- With minimal supervision, demonstrated capability in execution of an experimental program to address issues of process robustness, productivity, and cost, integrating efforts with specialists in other technical disciplines
- Knowledge of quality systems, Quality by Design, validation principles for product and manufacturing processes, engineering design, and statistical process control fundamentals
- Knowledge of cGMPs during pharmaceutical development and commercial manufacturing
- Strong interpersonal skills and the ability to work in a fast paced, multidisciplinary environment. Ability to work with minimal supervision and be a contributing member on cross functional assignments. Strong verbal and written communication skills are essential
- Knowledge of applicable regulations and regulatory filing (INDs/NDAs) expectations
11
Drug Product Continuous System Integrator Resume Examples & Samples
- PhD in a scientific discipline or
- Master of Science with 10+ years of experience in a technical role or
- Bachelor of Science with 15+ years of experience in technical role
- Preference will be given to candidates who are knowledgeable over a broad range of skills described above rather than deep mastery in any single skill. Pharmaceutical experience is preferred but not a prerequisite
- Developed and commercialized new technology or capability
- Demonstrated ability to develop continuous processes in any related industry
- Demonstrated ability to apply fundamental understanding of engineering principles into process dynamics
- Strong technical skills to supply business value
- Demonstrated leadership capabilities especially in a team environment
- Experience with manufacturing / process support
- Ability to prioritize multiple activities and manage ambiguity
12
Manager Drug Product Formulation Technology Resume Examples & Samples
- Performs and reviews product impact assessment for change control
- Evaluates new manufacturing records for formulation processes
- Performs and reviews scientific investigations (EOE & DNF), OOS and OOT IPCs
- Performs scientific evaluation of both process validation targets and ranges as well as manufacturing impact assessments and investigations as needed
- Develops/writes/plans and reviews protocols and activities for manufacturing support and process validation
- Serves as a subject matter expert (SME) for data trending, manufacturing support, and process validation
- Presents findings at group and possibly at interdepartmental meetings
- Communicate information on current process data and other IOPS initiatives which may impact process development and/or technology transfer
- Applies statistical process control tools in monitoring the manufacturing process
- Participates in process and quality risk assessments
- Assists in technical and scientific assessment during troubleshooting activities associated with the manufacturing process
- Supports off-site transfer activities as needed
- Reviews and/or approves Manufacturing documentation associated with the transferred process
- Develops validation procedures reflecting best practices in the industry and provide on the floor support and oversight during process validation campaigns
- Develop organizational standards and systems to meet growing product portfolio
13
Assoc Manager Drug Product Investigations Resume Examples & Samples
- Management of deviations encountered during aseptic filling at contract manufacturers
- Management of deviations encountered as a result of inconsistencies in primary container and closure manufacture
- Management of deviations encountered as a result of inconsistencies in delivery device performance and manufacture
- Provide technical leadership to internal and external groups in order to complete deviation investigations and disposition of supply
- Maintain strict adherence to quality system metrics targets and cycle time goals
- Propose standardization and business process improvements in order to increase efficiency and timeliness deviation investigation closure
- Provide regulatory filing support for drug product (IND, BLA, MAA, etc.) as well as support during regulatory inspection of site quality systems
- Monitor changing regulatory requirements, industry standards, and best practices for filling, delivery devices, and packaging. Ensure developments are communicated within the company and appropriately implemented
- Technical liaison between Regeneron Quality Control, Quality Assurance, Operations/Logistics Departments and contract manufacturers or business partners
- Maintain required training status for staff on Regeneron specific work instructions and SOPs
- Travel to manufacturers or business partners, as required
- BS/BA in engineering, materials science, physical or biological sciences or business with 4 years industry experience. MS with 3 years industry experience
14
Scientist, Drug Product Resume Examples & Samples
- Manage development, qualification, documentation, and transfer of assays
- Compile data and author reports summarizing experimental results for both real-time and accelerated studies
- Author method development reports, SOPs, and transfer protocols
- Perform statistical analyses on compiled data as needed and author reports for distribution and/or presentation to project teams
- Operate and participate in maintenance of lab instrumentation
- Knowledge and skills in chemistry and biochemistry (e.g. medicinal chemistry, bioanalytical chemistry, protein chemistry, protein expression)
- Current knowledge in vaccine literature and basic science related to vaccine development
- Strong math skills required. Working knowledge of statistical models for DOE, and familiarity with JMP is highly desirable
- Remain well versed in regulatory requirements to assure appropriate design and execution of vaccine manufacture and toxicology studies via services of CMO and CROs
- Comply with Takeda safety practices and standard operating procedures
15
Drug Product Project Leader Resume Examples & Samples
- To lead, manage and supervise the overall CMC drug product formulation and process development of Drug Delivery Systems (DDS) (internal / external)
- To define the CMC DDS development strategy and milestones in alignment with Product Soluton Team, Technical Solution Team and Technical Operation (TO)
- To plan and track the DDS CMC budget in alignment with the Technical Leader (TL)
- To deliver fit for purpose DDS deliverables on time and in full
- To ensure Quality by Design (QbD) and Process Analytical Technology (PAT) for DDS formulation and process development systematically
- To work in multidisciplinary and international teams
- To drive the decision making process in a multidisciplinary matrix organization
- To guide DDS development from pre-formulation until successful transfer to operations
- To prepare all relevant parts of the drug product development documentation as needed for filing/submission and active support of the registration process
- To support DDS lifecycle projects
- Master degree in Pharmaceutical Science or equivalent; PhD is an asset
- Minimum of 3-5 years professional experience in the pharmaceutical industry with a focus of drug product formulation and process development is mandatory
- Detailed understanding of NCE drug product development including: formulation, process and analytical development, scale-up, technology transfer and industrialization
- Thorough expertise in DDS (analytical and formulation /process development)
- Solid background in DoE and statistical data analysis
- Knowledge of cGMP, regulatory requirements and risk management techniques are mandatory
- Communication, influencing and negotiation skills in English and French languages to represent the department internally and externally
- Demonstrated ability to coordinate and track activities (e.g. technical project management)
- Skilled at writing and reviewing technical documents e.g. CTD
- Ability to work independently as well as in multidisciplinary teams in an international environment
16
Drug Product Packaging Engineer Resume Examples & Samples
- Author project specific Development Plans and execute key activities to support the design, characterization, and qualification of packaging components and container closure systems in accordance with DDR&D and PR&D quality system procedures
- Partner with key stakeholders (internal and external to Lilly) to enable project progression from clinical development through commercialization
- Design and lead the execution of studies to develop packaging component specifications to support incoming inspection processes
- Identify and develop new packaging technologies and interface with suppliers as needed to achieve component availability for clinical / commercial use to support products in development
- Conduct risk assessments to evaluate components, systems, suppliers, and processes
- Support shipping characterization studies for both drug substance and drug product
- Represent DDR&D in cross-functional project team meetings to communicate packaging strategy, component / system properties, risks, timing, and cost
- Present DDR&D deliverables during project technical reviews
- Evaluate and communicate the impact of supplier change notifications on drug substance and drug product packaging and regulatory commitments
- Support the authoring and technical review of regulatory submission documentation
- Stay abreast of regulatory and compendial requirements for packaging components and systems
- Manage work as part of a team and demonstrate the ability to manage multiple projects and prioritize work with supervisor guidance to accomplish goals
- Author experimental protocols, conduct experiments, and analyze results
- Document work in a clear, timely, and accurate manner
- Demonstrate the ability to quickly learn, understand, and communicate new processes and technical information
- Bachelor’s in Engineering or Bachelor’s in Packaging or Materials Science with 0-6 years of research and development experience in one of the following industries: pharmaceutical, consumer health/food science packaging, or medical device
- Engineering degree (mechanical, biomedical, packaging, or materials science preferred)
- Previous pharmaceutical, packaging, and/or medical device experience
- Strong understanding of pharmaceutical container closure system design and qualification
- Working knowledge of pharmaceutical industry regulatory directives, guidances, and compendial standards for packaging components and container closure systems (FDA, Ph.Eur, USP, WHO)
- Experience working in a GMP or highly regulated environment
- Strong technical problem solving skills and demonstrated ability to identify problems and drive issue resolution / improvements
- Experience leading and / or participating in formal risk assessments and integrating inputs / outputs into a risk management system
- Excellent technical writing skills and effective communication style
17
Drug Product Project Leader Resume Examples & Samples
- Minimum 7 years of successful industry experience in the development of pharmaceutical formulations (ideally oral solid dosage forms, solid understanding of QbD and biopharmaceuticals)
- Interdisciplinary thinking and interest in collaboration with other functions
- Excellent knowledge of laboratory and/or technical tools (e.g. QbD, statistical software, PAT)
- Broad and profound understanding of development activities and processes in pharmaceutical sciences.( early phase and late phase development)
- Successfully demonstrated track record of creativity and problem solving in projects
- Excellent communication skills, organizational, planning and negotiation skills
- Advanced coaching skills
18
Principal Scientist, Drug Product Resume Examples & Samples
- Develop new process unit operations or 2nd gen products for biologic and plasma drug product 20%
- Lead product/process development to commercialization for late stage drug products acquired through in-licensing 20%
- Tech transfer for drug product manufacturing 20%
- Drive in-use development studies for market expansion 10%
- Provide expertise and lead internal lab study design/execution for critical investigation when needed 10%
- Serve as a drug product SME for cross-functional project teams 10%
- Author/Review CMC sections/responses for process/product regulatory approval 10%
19
Drug Product Support Leader Resume Examples & Samples
- At least 8 years professional experience in a similar role in the field of Technical Operations, Process Management, Manufacturing within the pharmaceutical industry, preferably biotechnology
- Master degree or PhD in technical / scientific education, pharma - process engineering is preferred
- Experienced people manager enabling to connect teams with each other
- 6 Sigma and Statistical knowledge
- Broad knowledge and experience within the GMP environment, and regulatory affairs
- Very successful track record of change management projects and processes
- High level of customer orientation and organizational skills
- Flexible in mind / out of the box thinking
- Enthusiastic, decisive, motivating and convincing personality
- International background appreciated
- Excellent communication skills, verbal and written communication skills
20
Drug Product Engineer, Downstream Processing Resume Examples & Samples
- Define new business processes around Drug Product Manufacturing to support the startup of the new group
- SOPs, Batch Documents, Inventory, Spare Parts, Manufacturing Capacity Planning
- Design Visual Inspection Qualification Program for the manual inspection program
- Design, Qualification, Validation and Maintenance of equipment that supports Drug Product manufacturing and new Technology within Downstream Processing
- Work with other colleagues from around the network; coordinating activities, evaluating best practices in other areas, and working on continuous improvement project
- Support the development of Batch Documentation for DP Manufacturing
- Execute Batch Document / Run Equipment on the Process floor in coordination with other members of the team (Setup, Filling, Visual Inspection)
- Provide support for Process Simulations (Microbial / Personnel) and Investigations
- Support coordination of daily work schedules and effectively organize needed support groups by attending the Tier meetings
- Investigate and Purchase New technologies to bring efficiencies to the organization and make the area a leader of innovation within the global network
- At least 1 year of work experience in the pharmaceutical or biotech industry
- Familiarity with Biotech Manufacturing processes and a general understanding of Downstream Unit Operations
- Competent in analyzing complex situations and show practical problem solving capabilities
- Effective verbal or spoken communication skills
- Good communication skills in German and English
- At least 3 years of work experience in the pharmaceutical or biotech industry (sterile manufacturing of pharmaceutical or biological components/finished products)
- Demonstrated Microbiological knowledge and practical experience
21
Director, Drug Product Business Development Resume Examples & Samples
- Manages sites for key accounts in their area of geographic responsibility
- Provide technical guidance and expertise in the area of developability assessment, formulation development and clinical supplies
- Responsible for business development for all accounts in geographic responsibility
- Responsible for working with key account managers (KAMs) in other businesses to share data and manage a consistent face of Wuxi to the key account
- Responsible for analytical and formulation sales in his/her geography
- Responsible to grow revenue and build relationships in his/her geography
- Responsible for creating and sustaining a steady pipeline of business to ensure increasing year to year revenue growth
- Develops strategies to penetrate late-stage formulation and analytical development areas
- Develops plans and programs for key account sites in his/her geography to gain market share in existing businesses, cross sell formulation and analytical development and increase site penetration of all key accounts
- Develops strategies and tactics to gain new business in all accounts
- Achieves sales revenue targets for key accounts and new accounts
- Records activities and progress of key account efforts. Follow-up on BD activities
- Works closely with business units, project management team and marketing to ensure coordination of efforts and ensure good communication with all parties
- Helps to set up BU visits and stay involved when customers visit China
- Helps identify pull through services which should be emphasized and/or developed
- 5-10 years of relevant industry experience in formulation and analytical development and/or manufacturing
- 5+ years of sales, project management and/or business development experience
22
Scientist, Drug Product Resume Examples & Samples
- 50%: Perform technical/lab support of drug product formulation/process related study design, execution, data interpretation and share with DP lead(s) and teams in a scientific and concise fashion
- 30%: Participate in team activities as drug product SME/Lead to help CMC achieve project milestones, including PDTS team, tech transfer team, and other cross functional teams
- 10%: Author/review/verify DP related regulatory sections as appropriate
- 10%: Comply with departmental and organizational operations and procedures
- Must be well-organized, self-motivated and disciplined, and pay attention to technical details
- Able to communicate effectively in both oral and written
23
Scientist Drug Product Formulation Resume Examples & Samples
- BS, MS or Ph.D. in Pharmaceutical Sciences, Chemistry, Biochemistry, Biology, Chemical Engineering or related discipline with 5-7 years(BS), 3-5 years (MS) or 0 -3 (Ph.D.) of laboratory research experience
- Expertise in formulation development of vaccine drug product formulations
- Understanding of formulations for nucleic acids
- Able to work independently and take scientific direction from senior scientists
24
Finance Director, Drug Product Division Resume Examples & Samples
- Prepare quarterly and annual forecasts to support senior management of Drug Product and provide financial basis for investor guidance. Work with finance/accounting team to design/implement internal reporting including establishing product and project profitability
- Provide leadership for business development organization as far as pricing, revenue recognition, contract negotiation/analysis for the Drug Product business. Support margin improvement efforts
- Drive process and coordinate with senior management to develop annual budget. Monitor performance and initiate corrective action as required
- Prepare quarterly Board & employee business presentations and provide support to investor relations/communications team for any other external presentations
- Assist with M&A activities and capital programs as needed
- Provide special project support to CEO/CFO as required
- Provide leadership to develop teams to continually improve their performance
- BS degree or equivalent in Accounting or Finance. MBA in Finance is strongly recommended
- 10-15 years of financial management experience with increasing responsibilities in an organization with global operations. Manufacturing/Commercial experience preferred
- Demonstrated leadership capabilities including the ability to influence others outside of direct management sphere of influence
- Must be willing to travel on a monthly basis
- Proficient in use of Excel and demonstrated analytical skills
25
Director, Drug Product Manufacturing Resume Examples & Samples
- Identify, evaluate, qualify and manage CMO’s for GMP production of drug products
- Manage the strategic planning and execution of phase-appropriate qualification, validation, and scale-up of manufacturing processes for clinical and commercial drug products
- Write RFPs, negotiate proposals, manage a budget and verify invoices are consistent with work performed by CMO’s
- Lead CMOs in the development of new solid oral dosage forms
- Develop and direct strategies for pre-formulation, formulation, manufacturing scale up, tech transfer and process validation associated with Drug Product manufacturing
- Develop and/or review appropriate process validation strategies and statistical product sampling plans that provide the appropriate data and demonstration of process control to meet GMP requirements
- Support OOS, root cause, and CAPA investigations, as necessary
- Write, review, and approve GMP batch records, protocols and technical reports, as applicable
- Provide CMC and technical leadership for company’s global regulatory submissions (INDs, IMPDs, NDAs, MAAs, Meeting Requests, Briefing Documents, Responses to Health Authority questions, etc)
- Contribute to preparation and review of regulatory documents for submission to FDA and other regulatory authorities
- Manage and direct internal and external resources in a highly cross-functional environment
- Work with external consultants, as necessary
- Ph.D in pharmaceutical sciences, engineering, or related discipline with 10+ years or BS/MS with 15+ years of experience in pharmaceutical industry with hands-on background and experience with solid oral dosage forms
- At least 5+ years of experience in a scientific/technical CMC role with a history of working with and managing global CMO’s in a virtual manufacturing environment for the production of clinical and commercial drug product
- Experience in Design of Experiment (DOE) and Quality by Design (QBD)
- Very strong technical knowledge of pharmaceutical development and manufacturing of small molecules; understanding of pre-formulation and formulation development, manufacturing process development; experience with process scale-up, technology transfer and commercial drug product production
- Aware of analytical characterization of pharmaceutical products like drug release profile, in vitro in vivo correlation and understanding of bioequivalence studies
- Knowledge of regulatory guidelines and industry standards, including cGMP requirements, ICH guidelines and understanding of regulatory requirements and trends related to product development and commercial production
- Experience with commercial packaging including vendor selection, selection of packaging materials and packaging validation
- Motivated self-starter who can work independently with minimal supervision
- Demonstrated leadership capabilities, managing projects in an environment with strict timelines
- Highly collaborative; ability to work well with teams in a cross functional environment
- Experience managing and leading a team
- Up to 30% travel
26
External Drug Product Technical Services Resume Examples & Samples
- Minimum, B.S. degree in pharmaceutics, chemical/biochemical engineering, chemistry, or related physical or biological science, advanced degree preferred
- Minimum, 5 years’ experience in pharmaceutical development and parenteral manufacturing
- Experience with the development and/or manufacturing of sterile Drug Products, preferably relating to aseptic manufacturing processes for injectable pharmaceuticals and biologics
- In-depth knowledge of global GMPs and regulatory requirements for product registration
- Experience with statistical experimental design and data analysis preferred
27
Drug Product Technician Resume Examples & Samples
- Running of Equipment during Manufacturing: Component Preparation, Sterile Vial Filling, and Material Management
- Performing the 100% visual inspection of filled vials
- Maintain Equipment GMP Status: Routine Monitoring, Calibration, Maintenance, Certifications of equipment
- Reviewing and completing Batch documentation to support production activities
- Reviewing / Updating of Area SOPs
- Execute Process Simulation and support for Process Simulations and Investigations
- Supports coordination of daily work schedules and effectively organizes with respective support groups
- Inventory and Order Management
- At least 1 year of work experience in the pharmaceutical or biotech industry
- Familiarity with Biotech GMP Manufacturing processes and working within an Aseptic Environment
- Good communication skills in English (verbal and written); additional German language skills are beneficial
- At least 3 years of work experience in the pharmaceutical or biotech industry (sterile manufacturing of pharmaceutical or biological components/finished products)
- Demonstrated Microbiological knowledge and practical experience
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Summer Internship Formulation & Drug Product Sciences Resume Examples & Samples
- Investigate protein-exicipent interactions and to determine the effect(s) of formulation components on protein stability and product quality using appropriate biophysical and analytical techniques
- The intern will design, execute and analyze the data with proper training and guidance from mentor and SMEs
- The intern will present the data and findings at group meetings
- Must be in the process of earning a Bachelor’s or graduate degree
- Must have completed at least two full years of study
- Minimum 3.0 GPA
- Undergraduate or graduate majoring in biochemistry, chemical engineering, pharmaceutical sciences, pharmaceutics or related discipline
- Good academic tracking record capturing academic achievement
- Hands on experience with chromatography (e.g., HPLC), and other analytical methods preferred
- Protein formulation experience in academic or industrial setting desirable
- Ability to work effectively in a team environment
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Summer Internship Formulation & Drug Product Sciences Resume Examples & Samples
- During this summer internship, the candidate will gain in depth knowledge of industry standards for lyophilizing drug product, participate in ongoing collaborative research in microwave drying technology, and perform analytics in an accelerated stability study comparing the two technologies. This project will culminate in a presentation to the department highlighting the current state of each technology, summarizing their data from the stability study, and concluding on how these technologies impact the world of drug development
- The candidate will also have the opportunity to contribute to studies such as aggregation propensity of antibodies, conjugates and excipients using new technologies such Nanosight tracking analyses and low field NMR. These technologies will pave a new paradigm of particulates control for all programs of Seattle Genetics clinical and commercial products, as we stay at the forefront of industry and regulatory expectations
- What You Will Learn
- Our ideal candidate is someone who lives and breathes science, who is happy to be in the lab, and has excellent technical as well as communication skills. The ideal candidate should have a basic understanding of laboratory skills such as spectroscopy, small instruments experience and some background of protein chemistry
- Additional knowledge and experience with biophysical analytical methods will be helpful
- Desire to learn and ability to do so quickly
- Organized, with an ability to prioritize time-sensitive assignments
- Drive, Focus, Creative and Flexibility
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Senior Drug Product Engineer Aseptic Resume Examples & Samples
- Provide technical leadership within Manufacturing Technical Operations as a recognized subject matter expert in all aspects of commercial aseptic drug product manufacture
- Create policies, directives and procedures to ensure maintenance of technical best practice and regulatory compliance across the Alkermes’ drug product production network to ensure reliability of supply
- Ensure uninterrupted commercial supply through the creation of process control strategies and monitoring plans for drug product manufacturing process robustness and provide technical oversight of manufacturing operations
- Ensure robust and compliant process performance with continuous process verification through the use of lean six sigma tools
- Participate and provide technical input to all pharmaceutical drug product development projects with an aseptic requirement to ensure products are fully understood with data to support a process control strategy, demonstrate capability, are manufacturable, and are delivered to the patient in the most compliant manner
- Work across multiple functions and interact effectively with teams such as supply chain, quality assurance, engineering, manufacturing, EHS and regulatory affairs to provide technical input on aseptic processes and generate data required to support approvals and ongoing supply
- Support technology transfer of aseptic aspects of pharmaceutical drug products from one site to another within the organization and to CMOs, ensuring robust technical transfer, validation of new products, equipment and processes
- Support CMO selection process, liaise directly with the CMOs and represent the Alkermes organization and requirements at the CMO
- Communicate and participate in system and process investigations and troubleshooting with support team members and with external vendors, lead and participate in cross functional and cross network process improvement initiatives supported using Lean methodologies
- Contribute to the Technical Operations vision to ensure supply chain robustness within the Alkermes production network through the application of business and process understanding methodologies which are underpinned with a continuous improvement and process control mindset
- Flexibility in leading or working as part of a team as the need arises, preparation of documentation relevant to the role and demonstrate initiative in idea generation and development of systems to support the role
- Comply with all aspects of cGMP, Safety and Environmental legislation and Company policy where impacts on the role
- The role will involve ~20% of international travel
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Senior Drug Product Engineer Oral Solid Dosage Resume Examples & Samples
- Provide technical leadership within Manufacturing Technical Operations as a recognized subject matter expert in all aspects of commercial oral solid drug product manufacture
- Create policies, directives and procedures to ensure maintenance of technical best practice and regulatory compliance across the Alkermes’ drug product production network to ensure reliability of supply
- Ensure uninterrupted commercial supply through the creation of process control strategies and monitoring plans for drug product manufacturing process robustness and provide technical oversight of manufacturing operations
- Ensure robust and compliant process performance with continuous process verification through the use of lean six sigma tools
- Participate and provide technical input to all pharmaceutical drug product development/scale up and validation projects to ensure products are fully understood with data to support a process control strategy, demonstrate capability, are manufacturable, and are delivered to the patient in the most compliant manner
- Work across multiple functions and interact effectively with teams such as supply chain, quality assurance, engineering, manufacturing, EHS and regulatory affairs to provide technical input on oral solid dosage processes and generate data required to support approvals and ongoing supply
- Support technology transfer of pharmaceutical drug products from one site to another within the organization and to CMOs, ensuring robust technical transfer, validation of new products, equipment and processes
- Support CMO selection process, liaise directly with the CMOs and represent the Alkermes organization and requirements at the CMO
- Communicate and participate in system and process investigations and troubleshooting with support team members and with external vendors, lead and participate in cross functional and cross network process improvement initiatives supported using Lean methodologies
- Contribute to the Technical Operations vision to ensure supply chain robustness within the Alkermes production network through the application of business and process understanding methodologies which are underpinned with a continuous improvement and process control mindset
- Flexibility in leading or working as part of a team as the need arises, preparation of documentation relevant to the role and demonstrate initiative in idea generation and development of systems to support the role
- Comply with all aspects of cGMP, Safety and Environmental legislation and Company policy where impacts on the role
- The role will involve ~20% of international travel
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Specialist Engineering Sterile Drug Product Exmanfg Techology Resume Examples & Samples
- Ability to work effectively across boundaries to build strong collaborative relation with other internal GSTC partner groups, Small and Large Molecule Sites and external partners
- Demonstrated strategic ability to develop innovative solutions for undefined problems and business processes to meet the needs of key stakeholders and project sponsors
- A minimum of two (2) years experience in biological/pharmaceutical/chemical manufacturing
- Ability to travel up to 25% depending on site needs or vendor support required
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Associate Director Sterile Drug Product Exmanfg Techology Resume Examples & Samples
- Minimum Seven (7) years manufacturing experience in the areas of process start up and technical transfer or have demonstrated experience in these areas
- Strong professional and interpersonal communication skills are also required
- Must be able to multi-task and work within tight deadlines
- Flexibility and the ability to work independently as well as excellent organizational skills
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Drug Product Lead-cell & Gene Therapies Resume Examples & Samples
- Lead and co-ordinate the drug product team (functional experts) and represent Pharmaceutical Development on the global CMC team. Fulfill all related tasks and responsibilities related to own discipline
- Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant project team members
- Design, plan, perform and monitor all assigned drug product development activities applying state of the art technologies. Meet quality, quantity and timelines in all assigned projects
- Interpret results, evaluate data, draw relevant conclusions, and write reports
- Generate scientific documents to hand over to internal partners (GMP manufacturing plants, Device Development, Regulatory CMC, Clinics etc.)
- Actively support generation of international registration documents
- Contribute to overall development strategies and improvement of operational excellence of business processes
- Contribute to evaluation of new scientific technologies/equipment and proactively identify and realize opportunities for Invention Disclosures
- Represent pharmaceutical development in external collaborations and support assigned due diligence activities
- Coach junior team members
- Experience in cryopreservation and stabilization of cell suspensions is an asset
- Successfully demonstrated track record of creativity and problem solving in projects, interdisciplinary thinking, and proven ability to work in cross-functional, international teams
- Excellent organizational and planning abilities
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Manager, Drug Product Inspection Resume Examples & Samples
- Oversees and schedules visual inspection, labeling and packaging operations and staff within cGMP guidelines
- Interacts with clients and Manufacturing to assure successful technical transfer and integration of visual inspection, packaging and labeling processes into the Manufacturing Department
- Manages and facilitates interactions and communications with internal and external client stakeholders regarding production
- Interacts with potential clients, client auditors and regulatory bodies as subject matter expert
- Manages cGMP manufacturing activities including document production and review, internal and external driven continuous improvement projects, and assurance of cGMP compliance across all facilities
- Analyzes data and results and provides conclusions and proposals
- Troubleshoots manufacturing process problems. Leads the team to identify issues and propose adequate solutions
- Provides technical support to Manufacturing and Investigations staff within areas of specialty
- Employs high level technical expertise to develop new processes and creatively solve problems
- Writes/executes inspection protocols, SOPs, forms, and study reports
- Responsible for continuous employee training, education and coordinating guest speakers and seminars
- Responsible for automated cap coding and inspection systems
- Responsible for group metrics, analyzing results and presenting conclusions to Senior Management
- Researches and implements new methods and technologies to enhance operations. Suggests improvements to existing methods and procedures
- Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices
- Manages exempt and non-exempt Drug Product Inspection, Labeling and Packaging employees
- Responsible for establishing performance standards, employee coaching and development, determining employee responsibilities, evaluating performance and rewarding as appropriate
- Identifies recruits and retains top-notch talent
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Drug Product Project Leader Resume Examples & Samples
- Actively participate in teams, projects, networks /platforms. Fulfill all related tasks and responsibilities related to own discipline Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level to any other relevant project team member(s)
- Design, plan, perform and monitor all assigned activities Ensure quality, quantity and timelines in all assigned projects, networks and/or platforms. Support and assign associates in specific projects/networks. Coach on target dates and priorities
- Proactively participate in budget forecast, grant preparation and tracking of invoices. Ensure costs and cost awareness in all assigned projects/networks
- Advise team members and work according to appropriate SOP’s, GLP, DQP, GMP, OQM, HSE, ISEC and Novartis guidelines Interpret results, evaluate data, draw relevant conclusions and write reports
- Contribute to optimization of scientific/technical activities in assigned projects, network/ platforms/ processes
- Contribute to risk analyses /peer review and process challenge meetings
- Generate and select most appropriate scientific documents to hand over to internal and/or external partners (TechOps, authorities, other companies)
- Proactively support generation of international registration documents. Interact with authorities where appropriate Interact/collaborate with Research/other functions to facilitate transfer of knowledge and deliveries of DS/DP
- Actively support TRD on audits and inspections/Due diligence teams Provide quality assessment of potential in-licensing products in a timely manner and support follow-up activities as appropriate
- Proactively contribute to setting, updating and monitoring of team goals. Translate team goals into daily work
- Support and facilitate the journey towards a multi-skilled, highly innovative and motivated workforce operating in a self-directed team set-up. Drive cultural evolution and change management
- Successfully demonstrated several years (minimum of 3 years) of directly related experience
- Recognized expertise in a specific area
- Proven track record in utilization of special tools/equipment, lab automation tools and specialized facilities e.g., containment/sterile labs
- Thorough knowledge of state-of-art instrumentation/equipment for broad field of applications
- Thorough understanding of development processes in a specific function
- Profound literature search skills
- Ability to work in and/or lead interdisciplinary and/or cross-cultural teams
- Strong knowledge of relevant SOP, GLP, DQP, GMP and Novartis regulations and policies
- Strong communication skills. Strong presentation skills and scientific/technical writing skills. Advanced coaching skills
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Drug Product Specialist Resume Examples & Samples
- Maintain a thorough understanding of the customer's business and act as the customer advocate internally to cultivate and maintain positive customer relationships
- Target potential growth opportunities, consistent with Lonza's capabilities, and develop value propositions and actions plans to increase the project portfolio and, where applicable, licensing opportunities
- Support sales team, as necessary, to identify, develop and manage technology specific Global and Regional Key Account opportunities to deliver revenue growth at target accounts
- Act as the customer advocate and leverage internal team expertise to resolve problems and follow through on commitments, elevating critical issues to the appropriate management level for removal of organisational barriers to resolve customer problems
- For Global and Regional Key Accounts, either directly or assist account manager with planning and selling, proposal and contract negotiation processes, developing and deploying robust value propositions and action plans to assist close deals effectively and maximise margin
- Build and sustain a deep knowledge of the Lonza offerings in the specific technology areas of focus, such as Drug Product Services, in relation to key competitors, to ensure Lonza's value offering is strongly communicated and understood
- Perform Other Duties As Assigned
- Intermediate experience in product development role such as program management, CMC lead, lead technologist for drug candidate in field of technology focus: Viral / gene therapy and/or Cell Therapy, Drug Product Services
- Good command of English, written and verbal
- Demonstrated negotiation and presentation skills
- Strong interpersonal skills. Creative, adaptable, capable of self-motivation and independence
- Customer facing attitude. The ability to build relationships based on trust and long term commitment
- Strong gravitas, particularly in specific technology area of focus
- Leadership skills
- Experience of working in / and / or leading teams
- Has strong personal belief and self-confidence in their ability to effectively communicate technical capabilities in area of focus
- Has drive and desire to learn selling skills
- Has the strength of character to have tough conversation with customer
- Is optimistic and has the tenacity to bounce back from rejection
- Is keen to understand customer motivation and customer value drivers to realise full account potential
- Is comfortable operating with degrees of ambiguity
- Is objective in decision-making and balancing risk
- Demonstrates strong business awareness and commercial acumen in positioning Lonza products/services
- Builds enduring customer relationships based on trust
- Is effective at managing constructive tension during deal-making
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Technical Operations Drug Product Engineer Resume Examples & Samples
- To provide technical support and program management on oral solid dose NPI projects
- Takes ownership of the interface between pharmaceutical process requirements and OSD unit operation equipment
- Must be fluent in data analysis. Routinely extracts relevant information from multivariate production data to deliver process and robustness improvements
- Understands the influence of control systems on processing performance
- Works closely with Industrial Pharmacists, Analytical Scientists and Manufacturing Operations to deliver continuous improvement projects
- Planning and leadership of technical transfers for future product introductions to the site
- Work closely with Global Manufacturing Science and Technology and R&D, on the process development of future NPI products for AbbVie
- Degree in an engineering, science or materials science discipline
- 2 Years experience in development or transfer of Oral Solid Dosage forms
- Experience in new product introductions to pharmaceutical facilities is desirable
- Demonstrated project management skills, including the ability to deliver projects on schedule, within budget, and meeting the predefined quality requirements are required
- Experience in any of the following areas an advantage: tablet compression, encapsulation, wet granulation, roller compaction or tablet coating
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Specialist, Drug Product Manufacturing Resume Examples & Samples
- Identifies areas for Continuous Process Improvement and apply operational excellence tools to reduce process variability and steadily deliver measurable efficiency gains
- Report findings to management team and team members with recommendations for improvement. Research new methods or steps in a process, present findings, and make recommendations to the team, including developing new and revised Standard Operating Procedures, implementing new equipment and/or developing new processes
- Prepare ad hoc reports as requested and maintain/track operational KPIs
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Supervisor, Drug Product Inspection Resume Examples & Samples
- Directly supervises operations and staff within cGMP guidelines including visual inspection, clinical labelling, and packaging
- Interacts and communicates with clients regarding operations. Troubleshoots complex manufacturing process problems and issues
- Oversees review, revisions, and execution of finishing batch records
- Analyzes data and results and provides conclusions and performance metrics
- Responsible for staffing of visual inspection, clinical labelling and packaging operations
- Knowledgeable in Lean Six Sigma process improvement techniques
- Embodies Althea’s cultural values and aligns daily actions with department goals and company culture
- Manages non-exempt Drug Product Inspection staff
- Establishes performance standards, employee coaching and development, determining employee responsibilities, evaluating and managing performance and rewarding as appropriate
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Manager, Drug Product Data Resume Examples & Samples
- Collaborate with Manager, Product Data Communication to coordinate Drug Product Team workflow and achievement of department goals
- Manage the daily activities of the Drug Product Team to ensure the accuracy, completeness, and appropriateness of product data included in the product database; assist with quality assurance of data as needed
- Serve as the team's pharmacy subject matter expert for those questions and issues requiring pharmacy knowledge, expertise, and experience
- Monitor and evaluate state and federal regulations and legislation impacting data within the drug product database; maintain applicable data tables
- Monitor industry and professional trends impacting data within the drug product database and Elsevier drug information strategies
- Actively participate in industry organizations such as NCPDP as it relates to drug data and its application in pharmacy practice, clinical solutions, and industry standards
- Recruit, select, manage, and develop members of the Drug Product Team and immediate reporting staff; coordinate and manage the pharmacy intern program
- Develop and maintain policies and procedures as it relates to population of product data in the Product Editorial Tool
- Coordinate product photo shoots with sales and customers; ensure product images comply with Elsevier standards
- Participate in the development and review of business requirements and business cases for the Product Editorial Tool; interface with Elsevier Technology Services to develop and implement product data enhancements
- Provide support to Sales, Product Management and Marketing on the drug product content and editorial policies
- Other duties or tasks as assigned
- Proficient with Microsoft Office Suite including Windows, Word, Excel and Powerpoint
- Knowledge of Access or SQL is a plus
- Pharmacy school graduate with BS or PharmD degree; advanced degree is a plus
- Minimum 3 years of pharmacy practice experience, preferably in a retail or managed care setting
- Experience reading regulations/legislation and understanding the regulatory process is helpful
- Experience or familiarity with commercial drug databases and their use in pharmacy and other healthcare systems
- General understanding of relational databases and table structures
- Broad understanding of how drugs are aggregated for analytical purposes
- Excellent organization, communication, and interpersonal skills with a customer-oriented focus
- Motivation to work in a fast paced environment; must be capable of handling multiple tasks, working efficiently and meeting deadlines
- Ability to work autonomously as well as collaboratively with the Drug Product Team and other Elsevier or client cross-functional teams
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Director of Sales, Drug Product Resume Examples & Samples
- Ensure that existing accounts are serviced effectively, obtain orders, and establish new accounts by planning and organizing daily work schedule to call on potential clients
- Generate new business leads. Utilize strong interpersonal skills when negotiating contracts and/or bids and building long-term relationships with potential external partners and/or customers
- Assist the Vice President, Sales in identifying market potential by identifying client requirements, defining market, competitors’ share, and competitors’ advantages and weaknesses, forecasting projected business, establishing targeted Company share
- BS/MS in Organic Chemistry or another related scientific discipline preferred
- Minimum of 5 years sales experience in drug product development and/or cGMP manufacturing
- A positive and enthusiastic personality and the energy, drive and stamina to bring projects to a successful conclusion
- Strong commercial and negotiating skills, necessary to promote complex services to sophisticated clients in pharmaceutical and biotechnology R&D areas
- Good interpersonal, communications and presentational skills, capable of identifying appropriate clients and partners, establishing and maintaining the necessary effective business relationships
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Drug Product Manufacturing Associate Resume Examples & Samples
- Acts as the lead in daily operations ensuring all components are in place, operators are trained and all documentation is complete prior to finishing a campaign
- Schedules manufacturing tasks under cGMP guidelines and under the supervision of manufacturing supervisor
- Troubleshoots manufacturing processes that are semi-complex in level under cGMP guidelines and under the supervision of manufacturing supervisor
- Responsible for routine maintenance of production equipment and production suites
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Drug Product Inspection Technician Resume Examples & Samples
- Performs various manufacturing tasks under the guidelines of established SOP’s and cGMP regulations
- Performs visual inspection
- Labels and boxes filled goods
- Prepares and stocks packaging and labeling materials or supplies as needed
- Keeps equipment and production areas clean to comply with regulatory requirements
- Completes equipment documentation as required, including logbooks and binders
- Maintains production records as directed
- Collects and disposes of wastes according to established procedures
- Maintains cGMP environment
- Embodies Althea’s cultural values by aligning daily actions with department goals and company culture
- Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices
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Sales Operations Specialist, Drug Product Resume Examples & Samples
- Function independently to assemble written proposals to address client requests in a clear and concise document. Work closely with Business Development managers/directors to coordinate and ensure consistency of information submitted to individual clients in terms of pricing/verbiage used for similar projects, etc. Utilize and seek to improve company established tools and guidelines to generate pricing/verbiage for client proposals
- Apply judgment in determining whether proposal meets profitability criteria. Seek approval from finance and other business stakeholders as stated in company guidelines
- Review RFP to ensure an understanding of the request. If necessary, confer with the business development managers/directors who may interface with the client directly to ensure clarity of the request
- As necessary, guide and assist Business Development manager/directors and technical staff in the proper entry of bid process documentation in the CRM
- Submit proposals within client-requested timeframe or (if unstated), within AMRI’s standard timeline for prompt response to customer inquiries
- Manage and prioritize multiple proposals in various stages of completion in the bid process. Proactively seek necessary input from technical staff in order to ensure timely proposal submission to the client
- Assist Business Development manager/directors with lead generation and qualification. Generate new business leads using marketing lists, cold email, cold calling, social selling and networking. Qualify leads for increased revenue
- Proactively assist site General Managers and Finance Leaders to synthesize sales and scheduling data into value adding revenue forecast management information
- Work closely with General Manager and VP Sales & Marketing to generate rolling 6 month view of forecasted capacity utilization, identifying sensitivities and providing transparent view of schedule availability to sales organization
- Actively seek out sales & revenue improvement opportunities and support the requests from Senior Manager, Sales Operations & Proposals
- Participate in self development activities and training of others
- Exhibit safety awareness and safe work practices
- Perform other duties as may be reasonably assigned in the course of business
- Minimum B.S. in Business, Marketing, Finance, IT – knowledge of Chemistry, Engineering, or related field is desirable but not essential
- Must have excellent writing skills. Ability to read, analyze, and interpret common scientific, financial reports, and legal documents
- Must have excellent verbal communication skills. Ability to work with a wide variety of constituents to include but not limited to customers, sales team, technical staff, finance, legal, and senior executives
- Must have excellent organizational skills. Ability to prioritize tasks and maintain composure and productivity under periods of high intensity activity and tight deadlines
- Must be able to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
- Must be able to work effectively with diverse cultures represented by global internal staff as well as global customers, mostly by email and phone
- Must be able to perform math such as calculating sums and percentages
- Experience with Microsoft Office, particularly Outlook, Word, Excel, and PowerPoint
- Intuitive interest in business issues and keen desire to learn and ask questions
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Engineer, Drug Product Process Development Resume Examples & Samples
- Member of a dynamic scientifically driven team, dedicated to the development and optimization of robust manufacturing processes for drug products
- With the appropriate level of supervision, execute process development strategies to define manufacturing processes for commercialization
- With the appropriate level of supervision, design and execute complex experiments to characterize drug product manufacturing processes utilizing various technologies
- Apply fundamental engineering principles to characterize and solve process challenges across multiple unit operations, utilizing both experimental and process simulation/modeling approaches
- Utilize appropriate research tools, instrumentation, technologies, and methodologies to support efficient and effective drug product process development
- Support drug product process development/technology transfer to Contract Research/ Manufacturing Organizations
- Contribute to the preparation of CMC regulatory documents
- Assume departmental responsibilities for assigned projects and equipment
- Maintain safety, regulatory, and compliance standards as they relate to the development of pharmaceuticals
- With appropriate level of supervision, prepare technical reports, publications and oral presentations
- With the appropriate level of supervision, demonstrated capability in execution of an experimental program to address issues of process robustness, productivity, and cost, integrating efforts with specialists in other technical disciplines
- Strong interpersonal skills and the ability to work in a fast paced, multidisciplinary environment. Ability to be a contributing member on cross functional assignments. Strong verbal and written communication skills are essential
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Senior Principal Engineer Drug Product TS Resume Examples & Samples
- New product introduction and Process Validation
- Continuous improvement
- Normally requires an advanced degree in a scientific/technical discipline with 12-16 years technical hands-on industry experience in development and/or manufacturing (both highly preferred) or a BS with 14-18 years. Applies expert knowledge of scientific/technical principles & concepts
- Minimum of 10 years technical hands on process engineering experience with one or more of the following: modified release oral solids, liquids, sterile parenteral, ophthalmic and high potency formulations
- Recognized as an expert or leader in their specific field
