Director - Manufacturing - Pfizer - Andover

Job description
Role Description
Reporting to the Andover Manufacturing Sr Director, the Suite C,D Director will provide overall leadership for manufacturing functions essential for clinical Drug Substance (DS) and commercial Drug Substance (DS) production of FIX and BMP-2 occurring in Suite C,D. Working in partnership with Pharm Sciences and with Site Quality, EVM and Site enabling functions, this Suite Director is accountable for achieving business objectives for the manufacture of various drug substance products per the established Plan of Record in full compliance with government regulations and internal company standards/values. This individual will support and drive the implementation of Network Performance Principles and the use of Operational Excellence tools within their Suite and in collaboration with their Andover Manufacturing Suite A,B and E,F peers. Additionally, this individual will participate with Site wide initiatives, and when relevant collaborate with Bio-manufacturing Sciences Group (BSG), BioTx Pharm Sci, and the Specialty/Biotechnology Operating Unit network.


Responsibilities
*Manage and lead Suite C,D aspects of clinical and commercial DS product manufacturing, including technology transfer, adherence to the production plan of record, clinical requirements plan, cost controls, and maintenance of all manufacturing quality and cGMP standards.

*Continue to advance Suite C,Ds use of Right First Time/Six Sigma problem solving methodologies and lead efforts to advance Operational Excellence tools and innovative solutions to sustainably drive continuous improvement that will excel at meeting Network Performance Principles.


*Collaborate with BioTX Pharm Sci, Technical Services, BSG MS&T, and respective Business Unit to drive process improvement programs to gain improved robustness of Suite C,D tech transfer, and drug substance supply processes, (clinical, FIX, BMP-2 and commercial/launch).

*Develop ways of working that will support and contribute to the site GoalZERO safety efforts and will meet all required environmental and industrial hygiene requirements.


*Partner with Technical Services, BioTx Pharm Sci to support Suite C,D technology transfer of mammalian pre POC, post POC and possible Launch DS processes.

*Support and actively collaborate with Quality, EVM, Site Tech Services and Regulatory to meet the increasing expectations of Board of Health inspections, and when necessary, support filings associated with Suite C,D.

*Serve as member of the Andover Manufacturing Leadership Team and actively champion Manufacturing Organization strategies to drive advancements of the informatics program, promote cross Suite standardization, implementation of flexible work force, and sustainable practice of Sig Sigma and OE principles.

*Lead the budget and resource planning process for Suite C,D manufacturing in conjunction with other functions.

*Responsible for Suite C,D talent planning and development that includes coaching and mentoring, development and performance management.

*Collaborate with Quality & Compliance and Technical Services in technical problem solving, investigations and defining CAPA.

Qualifications
*MS/MA, or B.Sc. Degree in Sciences, Engineering or related field.
*A minimum of 10+ years experience in the Pharmaceutical manufacturing industry.
*Must have administrative, managerial skills, technical report writing, computer, and presentation skills.
*Experience in pharmaceutical manufacturing, process equipment and cleaning qualification/validation.
*A working knowledge of the relevant portions of cGMP regulation is required.
*Good communications and ability to interact across functional and divisional boundaries.
*Demonstrated leadership skills including effective team and individual development.
*Demonstrated ability to operate in a "matrix" organizational environment, transcending organizational boundaries, while leading change and delivering innovative solutions to the business.
*Demonstrated ability to seize accountability, to hold people responsible, and to act decisively.
*Understanding and demonstrated use of Operational Excellence techniques leading to achievement of best in class Network Performance Principles.

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