Pfizer Scientist, Formulation Development in St. Louis, Missouri
This position will be part of Pharmaceutical Research and Development. The incumbent will participate in the formulation and process development, scale-up and transfer of protein therapeutics formulations and manufacturing processes. This position will be responsible for performing analytical characterization of candidate molecules by using various biophysical and biochemical characterization techniques. This is a laboratory-based position performing formulation and process development activities specifically for protein therapeutics products from pre-clinical and Ph I clinical trials through manufacturing process performance qualification, license application and commercialization. Furthermore, this position will assist in developing processes for drug product manufacturing, responsible for data compilation, data presentations and report writing.
The responsibilities of Scientist position include but are not limited to :
Participate in developing parenteral formulations for biotherapeutic modalities such as monoclonal antibodies, antibody drug conjugates, proteins and vaccines. Participate in developing and defining novel formulations for protein therapeutics products. This position will be responsible to assist in developing manufacturing processes (under general supervision).
Perform rapid, comprehensive characterization of candidate molecules to determine the stability profile and applying this information to develop an appropriate dosage form to meet clinical needs. This will be achieved by applying various biophysical and biochemical techniques such as HPLC (SE-HPLC, IEX, RP-HPLC), SDS-PAGE, Capillary Gel electrophoresis (CGE), imaged Capillary Electrophoresis (iCE), Spectroscopy techniques such as UV and Fluorescence spectroscopy, Circular Dichroism and FTIR.
The incumbent will assist in the development and scale-up of processes from bench top to pilot scale and, as required, technology transfer to commercial plants.
The Scientist must be able to interact effectively
with a multi-disciplinary team of scientists for formulation optimization and overall candidate progression.
This position will be responsible for preparing data summary presentation, compiling data and authoring technical reports.
Effective communication skills are desirable for interactions with laboratory scientists, project managers and colleagues from numerous functions, serving on multi-disciplinary project teams.
M.S. with more than 3 years experience or B.S. with more than 6 years of experience or Pharmaceutics, Chemistry, Chemical/Biochemical Engineering, Pharmacy, Biochemistry, Bioengineering, Biotechnology, Biology or equivalent with 0-3 years' experience
0 to 3 years industrial experience in parenteral formulation and process development of biotherapeutics.
Familiarity with proteins and analytical techniques
Working knowledge of formulation and process considerations for biotherapeutics including cell and gene therapy, vaccines, monoclonal antibodies, etc.
Familiarity with GLP/GMP requirements
Familiarity in scale-up and technology transfer to pilot/commercial scale
Knowledge of considerations for protein structure and stability considerations
Eligible for Employee Referral Bonus: Yes
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EEO & Employment Eligibility
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Research and Development