Pfizer Principal Scientist, Culture Process Development in St. Louis, Missouri
The Upstream Process Development group of Pfizer in Chesterfield, MO is seeking a highly motivated and energetic scientist/engineer interested in working on the forefront of mRNA cell free synthesis technology including In Vitro Transcription (IVT) process development for mRNA manufacturing to support Pfizer's growing pipeline.
The successful candidate will indirectly lead a multidisciplinary project team that is responsible for the development of mRNA IVT manufacturing processes including: scale-up/scale-down, tech transfer, process characterization, authoring of associated regulatory submissions and leading new technology development initiatives.
It is your strong technical, strategic and organizational leadership that will help to effectively manage a multi-project development portfolio and make strong technical and strategic contributions to ensure efficient and timely execution of CPD deliverables.
Responsible for successful development, characterization and execution of state-of-the-art cell free IVT manufacturing processes for mRNA .
Apply scientific and technical experience and business acumen to establish strategies, drive safe and high-quality lab technical work and deliver well-controlled and characterized mRNA manufacturing processes.
Provides visible, passionate and optimistic organizational, technical and personal leadership to colleagues as well as mentor more junior colleagues in specific lab techniques or processes.
Fosters colleague engagement and models desired values and behaviors, including quality, integrity, respect, collaboration and personal accountability
Uses FDA/EMA Regulatory expectations to drive high quality, compliant manufacturing procedures and outcomes
Contributes to Project, Technical and Strategic Teams as appropriate; reaches across organizational, functional and geographic boundaries to provide appropriate context and communication (in both directions) so as to ensure effective technical and strategic integration at all internal and external interfaces (Research, Bioprocess development, Analytical, Safety, CMOs, Commercial manufacturing, etc.), as appropriate.
Establishes and drives relevant and impactful innovation programs, to enhance mRNA manufacturing/ characterization technologies and work-processes; ensures that innovation strategy is aligned with broader business drivers and current and emerging Regulatory paradigms.
Ensures effective, high-quality, timely and appropriate documentation in electronic laboratory notebooks and internal Technical Reports; contributes to Regulatory Filings and responses to Regulatory questions; presents data/ strategy to scientists and management in appropriate internal and external venues (technical meetings, Project Team meetings, conferences) and publishes in peer-reviewed journals, as appropriate.
Degree in Chemical/Biochemical Engineering, Biotechnology, Biochemistry, Cell Biology, Microbiology or related field
PhD with 3+ years' experience or MS with 9+ years' experience with relevant industry experience focused in the following:
Development and characterization of cell free mRNA manufacturing processes for vaccines and therapeutics
Knowledge in developing cost effective, scalable cell free mRNA manufacturing processes.
Scale-up/ Scale-down of mRNA processes.
Knowledge in In Vitro Transcription processes for manufacturing mRNA
Demonstrated experience with managing multiple projects in parallel, including key participation on multi-disciplinary project teams.
Nice to Have
Experience in authoring INDs, BLA/MAAs and other regulatory documents
Demonstrated experience in process development utilizing quality risk management and quality by design concepts.
Experience in developing mammalian cell culture and microbial processes
Ability to perform mathematical calculations and ability to perform complex data analysis
Capable of carrying out mRNA IVT experiments in the lab
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Travel to other Pfizer sites (St Louis MO, Andover MA and others) and to support process Tech Transfer to contract manufacturing organizations in USA/ Rest of World as appropriate
Other Job Details
Last Date to Apply for Job: March 8, 2021
Eligible for Relocation Package: YES
Eligible for Employee Referral Bonus: YES
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Research and Development