Sr. Principal Scientist, Cell Therapy Manufacturing Process
Sr. Principal Scientist, Cell Therapy Manufacturing Process
Org Marketing Statement
All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That’s why, as one of the global leaders in the biopharmaceutical industry, Pfizer is committed to seeking out inspired new talent who share our core values and mission of making the world a healthier place.
Help establish and lead a technical team to develop and characterize clinical-scale manufacturing processes for Chimeric Antigen Receptor T-cell (CART) therapies, produce non-GMP material suitable for IND-enabling Toxicology studies, and tech transfer and support successful GMP manufacturing and release, initially at a CMO. Develop novel processing technologies and approaches (such as alternate transfection/ cell engineering strategies, media development, disposable/ closed production systems, automation), to meet future Cell and Gene Therapy manufacturing needs (increased control/ scalability and reduced costs), and publish in peer reviewed journals. This position will work in close collaboration with key stakeholders including the CART Research group and external CART collaborators.
Responsible for successful development, characterization and execution of state-of-the-art manufacturing processes for lentiviral-based, engineered T-cell therapies – accomplished technical leader who applies extensive scientific and technical experience and business accumen to establish strategies, drive safe and high-quality lab technical work and deliver well-controlled and characterized production processes. Provides creative and pragmatic technical and operational problem-solving options.
Responsible for successful execution of clinical-scale processes for non-GMP, IND-enabling, Toxicology studies that are compatible with/ representative of intended GMP clinical manufacturing; Tech Transfer to GMP facility and support for successful manufacturing and release of GMP material. Experienced process development scientist/ engineer who drives high quality, compliant Cell and Gene Therapy manufacturing procedures, familiar with cGMP manufacturing needs and FDA/ EMA Regulatory expectations
Provides visible, passionate and optimistic organizational/ technical/ personal leadership and actively fosters colleague engagement and development; models and engenders desired values and behaviors, including quality, integrity, respect, collaboration and personal accountability.
Has the 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 CART manufacturing/ characterization technologies and work-processes (such as alternate transfection/ cell engineering strategies, media development, disposable/ closed production systems and automation), and publishes in peer-reviewed journals, as appropriate; 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 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.
EDUCATION AND EXPERIENCE
PhD degree in Molecular Immunology/ Molecular Virology or related field, or Chem. Engineering degree (with appropriate Cell and Gene Therpay focus) - with 10+ years of postgraduate experience in biotech/ biopharma industry required (preferably in the development and characterization of manufacturing processes for cell- or gene-therapies).
Grade level/ position commensurate with experience.
TECHNICAL SKILLS REQUIREMENTS
Relevant and significant experience in some or all of the following areas:
-Process development for GMP manufacturing of cell- or gene-therapies
-T cell molecular biology/ engineering and characterization of primary T cells
-Molecular virology/ engineering and production of recombinant viruses
-Mammalian cell genome engineering
-Familiarity with cGMPs and appropriate Regulatory Guidance documents
PHYSICAL POSITION REQUIREMENTS
Travel to other Pfizer sites (St Louis MO, Andover MA and others) and to support process Tech Transfer to contract manufacturing organizaitons in USA/ EU as appropriate
Equal Employment Opportunity
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.
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