Pfizer Senior Associate Scientist, Formulation Development (non PhD) in St. Louis, Missouri
This position will be part of Pharmaceutical Research and Development. The incumbent will be functional team member in formulation and process development, scale-up and transfer of protein therapeutics formulations and manufacturing processes of various biologics modalities such as gene therapies, monoclonal antibodies, antibody drug conjugates, proteins and vaccines.
This position will be responsible for performing basic lab techniques and having a good understanding of analytical characterization techniques including but not limited to DNA analysis, recombinant protein expression, quantitative PCR assays, viral potency and quantification assays as well as protein biophysical and biochemical characterization techniques.
This is a laboratory-based position performing formulation and process development activities specifically for biotherapeutic products from pre-clinical, through clinical manufacturing, manufacturing process performance qualification, license application and commercialization. This position will work within a technical team to develop processes for drug product manufacturing, execute data compilation, present data and write technical reports.
The responsibilities of Associate Scientist position include but are not limited to :
Perform rapid, comprehensive characterization of candidate molecules to determine the stability profile and apply this information to develop an appropriate dosage form to meet clinical and manufacturing needs.
Apply various biophysical, biochemical and gene therapy characterization techniques such as quantitative PCR, viral potency, HPLC (SE-HPLC, IEX, RP-HPLC), SDS-PAGE, Capillary Gel electrophoresis (CGE), imaged Capillary Electrophoresis (iCE), and spectroscopy techniques such as UV.
Assist in the development and scale-up of processes from bench top to pilot scale and, as required, technology transfer to commercial plants.
Interact effectively with a multi-disciplinary team of scientists for formulation optimization and overall candidate progression.
Prepare data summary presentations, compile data and author technical reports.
Have effective communication skills for interacting with laboratory scientists, project managers and colleagues from numerous functions, serving on multi-disciplinary project teams.
Independently lead and evaluate technical problems and offer solutions at tech team level.
Apply learnings to increase productivity.
Integrate and implements prior learnings to new projects.
Leverage knowledge to troubleshoot technical problems.
Represents team but know when to ask for help for critical /strategic tasks.
Trains others, apply knowledge and skills with minimal supervision.
M.S. degree in Pharmaceutics, Chemistry, Chemical/Biochemical Engineering, Pharmacy, Biochemistry, Bioengineering, Biotechnology, Biology or B.S. degree plus 3 years of experience in Pharmaceutics, Chemistry, Chemical/Biochemical Engineering, Pharmacy, Biochemistry, Bioengineering, Biotechnology, Biology
0 to 3 years of industrial experience in parenteral formulation and process development of biotherapeutics.
Functional skill level in performing biotherapeutic analytical techniques.
Functional skill level of scientific report writing.
Basic knowledge of scientific data integrity and compliance processes.
M.S degree in Gene Therapy, Pharmaceutics, Chemistry, Chemical/Biochemical Engineering, Pharmacy, Biochemistry, Bioengineering, Biotechnology, Biology or equivalent with 1-3 years industrial experience or a B.S. degree in Gene therapy plus 3 years of experience in Pharmaceutics, Chemistry, Chemical/Biochemical Engineering, Pharmacy, Biochemistry, Bioengineering, Biotechnology, Biology
Experience in being on teams associated with formulation development, pharmaceutics, pharmacy, drug product manufacturing, and scale-up of gene therapy modalities.
Basic knowledge of formulation design for biotherapeutic modalities.
Excellent oral and written communication skills.
Functional skill level in understanding of biophysical attributes of biotherapeutics.
Basic knowledge of analytical and bio-analytical methods for gene therapies.
Basic knowledge in scale-up and technology transfer of aseptic processes to pilot/commercial scale manufacturing facilities.
Basic knowledge of thermodynamics and kinetics.
Basic knowledge in GLP/GMP requirements.
Basic knowledge of regulatory submissions (IND, IMPD, BLA, MAA).
Other Job Details:
Eligible for Relocation Package: no
Eligible for Employee Referral Bonus: yes
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Research and Development