A Senior Principal Scientist/ Group Leader position is available within the Culture Process Development (CPD) group in Bioprocess R&D (BRD). The successful applicant will lead a group of scientists and engineers responsible for the development of scalable culture processes for the clinical/ commercial manufacture of proteins and other biologicals,. She/He will be expected to provide strong technical, strategic and organizational leadership, effectively manage a multi-project development portfolio and make strong technical and strategic contributions to multi-disciplinary/ cross-functional development project teams so as to ensure efficient and timely execution of CPD deliverables.
- Responsible for successful development, characterization and execution of state-of-the-art manufacturing processes for mammalian and microbial cultures– accomplished technical leader who applies extensive scientific and technical experience and business acumen to establish strategies, drive safe and high-quality lab technical work and deliver well-controlled and characterized manufacturing processes. Provides creative and pragmatic technical and operational problem-solving options. Experienced (cGMP) manufacturing operations leader familiar with FDA/ EMA Regulatory expectations, who drives high quality, compliant manufacturing procedures and outcomes.
- Provides visible, passionate and optimistic organizational/ technical/ personal leadership and actively fosters colleague engagement; models and engenders desired values and behaviors, including quality, integrity, respect, collaboration and personal accountability.
- Has the ability and mastery (technical and interpersonal skills, awareness of functional area deliverables and business/ Regulatory context) to train/ mentor more junior colleagues in specific lab techniques or processes.
- Establishes and drives relevant and impactful innovation programs, to enhance upstream manufacturing/ characterization technologies and work-processes; ensures that innovation strategy is aligned with broader business drivers and current and emerging Regulatory paradigms.
- 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.
- 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.
- Contributes to safe, efficient, effective and harmonious lab environment through personal responsibility/ accountability – ensures appropriate cleanliness and status/ operability of shared or assigned lab space or equipment; strong lab citizen and collaborative team player; approaches the job with energy and commitment; demonstrates initiative – identifies what needs to be done and makes it happen.
PhD degree in Chemical/BiochemicalEngineering, Biotechnology, Cell Biology, Microbiology or related field, - with 6+ years of postgraduate experience in biotech/ biopharma industry in the development and characterization of mammalian cell culture/ microbial fermentation processes for therapeutic proteins and monoclonal antibodies
Relevant and substantial experience in some or all of the following areas:
- Expert knowledge in developing cost effective, scalable culture processes
- Scale-up/ Scale-down of bioreactor processes
- Demonstrated supervision / leadership of high caliber scientists and ability to mentor junior staff and peers
- Demonstrated experience with managing multiple projects in parallel, including key participation on multi-disciplinary project teams.
- Experience in authoring INDs, BLA/MAAs and other regulatory documents
- Demonstrated experience in process development utilizing quality risk management and quality by design concepts.
- Knowledge of stem cells/ cell therapy process development a plus
Ability to perform mathematical calculations and ability to perform complex data analysis; Capable of carrying out cell culture experiments in the lab
Work Schedule/Travel: Travel to other Pfizer sites (Andover MA and others) and to support process Tech Transfer to contract manufacturing organizations in USA/ Rest of World as appropriate