Pfizer Principal Scientist in Chesterfield, Missouri
A career at Pfizer offers opportunity, ownership and impact.All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
The Culture Process Development (CPD) group of Pfizer in Chesterfield, MO is seeking a highly motivated and energetic scientist/engineer interested in working on the forefront of cell culture bioreactor process development. The CPD Principal Scientist will work with a larger team of scientists responsible for the development of new technologies, scale-up/scale-down, characterization of mammalian and/or microbial culture processes, late stage process development/tech transfer to manufacturing sites and associated regulatory filing activities. The successful applicant will be expected to effectively lead a multidisciplinary project team that is 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 scientific and technical experience and business acumen to establish strategies, drive safe and high-quality lab technical work and deliver well-controlled and characterized late stage 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 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. 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 upstream 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. 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 with 5 or MS with 10 years' experience with degree in Chemical/Biochemical Engineering, Biotechnology, Biochemistry, Cell Biology, Microbiology or related field, with relevant experience in biotech/ biopharma industry focused in the development and characterization of mammalian cell culture 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 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. PHYSICAL/MENTAL REQUIREMENTS Ability to perform mathematical calculations and ability to perform complex data analysis; Capable of carrying out cell culture 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#LI-SA1
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
Principal Scientist Chesterfield, Missouri 1048617-1852