Pfizer Senior Principal Scientist , Group Lead in St. Louis, Missouri
This position will be part of Pharmaceutical Research and Development. The candidate will lead the development,
scale-up and transfer of parenteral formulations and manufacturing processes for various biologics modalities such as gene
therapies, monoclonal antibodies, antibody drug conjugates, proteins and vaccines. This is a project and people leadership-based position performing formulation and process development activities for biotherapeutic molecules from pre-clinical and Ph I clinical trials through manufacturing process performance qualification, license application and commercialization.
The Senior Principal Scientist, Biotherapeutics Pharmaceutical Research and Development will be responsible for the performance and development of 6-8 colleagues within the group. The candidate will be a member of the leadership team and help influence the formulation and process development strategies across the portfolio.
The Senior Principal Scientist, Biotherapeutics Pharmaceutical Research and Development is responsible for developing parenteral formulations, alternate drug delivery systems, and tech transfer manufacturing processes to enable the successful development of biotherapeutic drug products including gene therapies, prophylactic and therapeutic vaccines and protein-based modalities. The position will involve leading a technical project team that will apply characterization and stability information to develop an appropriate dosage form to meet clinical and commercial needs. The position is responsible for leading the formulation and development activities from pre-clinical and Ph I clinical trials through commercialization.
The candidate is responsible for developing/identifying new technologies and procedures to accelerate the biotherapeutic development process across projects.
- PhD., M.S. with 8-12 years industrial experience, or B.S. with 12 or more years of industrial experience in Pharmacy, Pharmaceutics, Biomedical Eng, Chemical Eng, Biochemistry, Biotechnology, Virology, Biology or equivalent scientific field.
- PhD., M.S. with 8-12 years industrial experience, or B.S. with 12 or more years of industrial experience in biotherapeutic formulation development and scale up.
- Experience in formulation development, pharmaceutics, pharmacy or drug product manufacturing or scale-up of biotherapeutics modalities.
- Experience in leading teams associated with formulation development, pharmaceutics, pharmacy, drug product manufacturing, and scale-up of gene therapy modalities through regulatory filing and commercial launch.
Experience in biotherapeutic parenteral drug product formulation or process development of protein or gene therapy or vaccines.
Experience in leading multidisciplinary technical teams.
Experience in responsibility for performance and development of direct reports.
Working knowledge of regulatory filing process.
Excellent oral and written communication skills.
Experience in leading and developing direct reports and peers across matrix teams.
Excellent leadership skills
Expert understanding and leadership of technical area necessary for biotherapeutic molecule formulation development.
Experience in scale-up and technology transfer of aseptic processes to pilot/commercial scale manufacturing facilities
Solid understanding of thermodynamics and kinetics
Working knowledge of GLP/GMP requirements Experience in authoring regulatory submissions (IND, IMPD, BLA, MAA)
Experience in application of QbD concept in design, execution, and interpretation of formulation and process development experiments.
"Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact."
Other Job Details:
Eligible for Relocation Package: YES
Eligible for Employee Referral Bonus: YES
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Research and Development