The Senior Scientist, Biotherapeutics Pharmaceutical R&D (BTx PhRD), is a laboratory based position for performing formulation and manufacturing process development activities of therapeutic biologic drug products including cell and gene therapy, prophylactic and therapeutic vaccines as well as therapeutic protein-based modalities ranging from pre-clinical and Ph I clinical trials through commercialization. The position will involve use of innovative and modern techniques to develop and characterize dosage forms with appropriate stability profiles and develop associated manufacturing processes to meet project needs. Data generated by the incumbent will be utilized to nominate dosage forms, support clinical trial applications, scale-up and enable transfer of manufacturing processes, and to support product licensure related activities in accordance with ICH guidances Q8 and Q9. The incumbent will author written documentation and regulatory filings associated with his/her work, and will participate in technology transfer activities to manufacturing sites. The Senior Scientist, BTx PhRD, must be able to interact effectively with a multidisciplinary team of scientists and engineers for formulation and process optimization and overall product development. Effective communication skills are essential for interactions with laboratory scientists, project managers and colleagues from numerous functions, serving on multidisciplinary project teams.
PhD. with 0-3 years, M.S. with 7+ years, or B.S. with more than 10 years of industrial experience in Pharmacy, Pharmaceutics, Biomedical Engineering, Chemical Engineering, Biochemistry, Biotechnology, Virology, Biology or equivalent.
Newly qualified Ph.D. or 7+ years with M.S. or B.S with more than 10 years of industrial experience in formulation development, pharmaceutics, pharmacy, drug product manufacturing, and scale-up.
Knowledge of process development and formulation techniques of any of the following: Protein, cell and gene therapy, vaccine oligonucleotide
Experience in biotherapeutic parenteral drug product formulation or process development of protein/peptide, vaccines or oligonucleotide therapeutics.
Excellent oral and written communication skills and ability to mentor junior staff and peers across matrix teams.
Understanding of biophysical attributes of biotherapeutics
Knowledge of analytical and bio-analytical methods for biologics
Experience in vaccine formulation and process development
Experience in scale-up and technology transfer of aseptic processes to pilot/commercial scale manufacturing facilities.
Theoretical and practical knowledge of lyophilization and lyophilization cycle development.
Experience working with cells and virus.
Solid understanding of thermodynamics and kinetics.
Familiarity with GLP/GMP requirements.
Experience in authoring regulatory submissions (IND, IMPD, BLA, MAA).
Familiarity with combination product development and design control.
Experience in application of QbD concept in design, execution, and interpretation of formulation and process development experiments.
Knowledge of ICH Q8 and Q9 guidance.
Familiarity with Intellectual Property (IP).
3 openings. Employer will assist with relocation costs.
Internal Number: 4744590
About Pfizer, Inc
Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.