Principal Scientist, Formulation Development
Posted on Apr 5, 2021 by Pfizer
This position will be part of Pharmaceutical Research and Development which has developed formulations for advancing vaccines for deadly adolescent and adult infections including Meningococcal disease, Staphylococcus aureus and Clostridium difficile. The candidate will lead the formulation development, scale-up and transfer of vaccine modalities. This is a project-based position performing formulation and process development activities for vaccines from pre-clinical and Ph I clinical trials through manufacturing process performance qualification, license application and commercialization.
The Principal Scientist, Biotherapeutics Pharmaceutical Research and Development is responsible for developing parenteral formulations, and tech transfer manufacturing processes to enable the successful development of novel antigen presenting technologies and adjuvant vaccine drug products. The position will involve leading a technical project team that will apply characterization and stability information to develop an appropriate dosage form to meet vaccine 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 also responsible for executing new technologies and procedures to accelerate the biotherapeutic development vaccine processes across projects.
B.S. in Pharmaceutics, Chemistry, Chemical/Biochemical Engineering, Pharmacy, Biochemistry, Bioengineering, Biotechnology, Biology, Biomedical engineering and at least 12 or more years industry or equivalent experience
M.S. in Pharmaceutics, Chemistry, Chemical/Biochemical Engineering, Pharmacy, Biochemistry, Bioengineering, Biotechnology, Biology, Biomedical engineering and at least 8-12 or more years industry or equivalent experience
Ph.D. in Pharmaceutics, Chemistry, Chemical/Biochemical Engineering, Pharmacy, Biochemistry, Bioengineering, Biotechnology, Biology, Biomedical engineering and at least 5-9 or more years industry or equivalent experience.
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 vaccine modalities through regulatory filing and commercial launch.
Experience in biotherapeutic parenteral drug product formulation or process development of 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.
Demonstrates ownership and can see things through (end-to-end).
Sound understanding of when decisions should be made/elevated.
Demonstrates One Pfizer behavior.
Conceives and drives line initiatives, technology development and CMC strategy.
Serves as a mentor and demonstrates ability to serve as a role model.
Influences lines outside of Pharmaceutical Research and Development - can devise and explain strategy, concepts and complex technology to experts and non-experts alike.
Builds effective relationships with cross-functional Pfizer customers (eg, listening skills, demonstrates empathy, conflict resolution).
Benchmarks and stays current with external publications, conferences or meetings.
Scientific contributions recognized outside of Pharmaceutical Research and Development; increased external influence (eg,. publication, consortium, regulatory influence)
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
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