Pfizer Scientist, Formulation in Andover, Massachusetts
This position will be part of Pharmaceutical Research and Development group within BioTherapeutics Pharmaceutical Sciences Organization. The Scientist will participate in the development of parenteral formulations for biologics modalities such as monoclonal antibodies, proteins, vaccines, viral vectors for genomic therapeutics, oligonucleotides and various drug delivery modalities.
This is a laboratory-based position performing formulation and process development activities for biologic products from pre-clinical and Ph I clinical trials through manufacturing process performance qualification, license application and commercialization.
This position will be responsible for performing analytical characterization of candidate formulations by using various biophysical and biochemical characterization techniques.
Furthermore, this position will assist in developing processes for drug product manufacturing. The colleague will be responsible for data compilation, data presentations and report writing. The scientist will interact with cross functional development teams working with all levels of employees.
The responsibilities of the Scientist position include but are not limited to: Participate in developing parenteral formulations for biotherapeutic modalities.
Help develop manufacturing processes for these parenteral drug products.
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 needs. This will be achieved by applying various biophysical and biochemical techniques such as HPLC (SE-HPLC, IEX, RP-HPLC), capillary gel electrophoresis (CGE), imaged capillary electrophoresis (iCE), spectroscopy techniques such as UV and fluorescence spectroscopy, circular dichroism and FTIR.
The Scientist will assist in the development and scale-up of drug product manufacturing processes, including liquid filling operations, filtration and lyophilization, from bench top to pilot scale, and, as required, technology transfer to manufacturing plants.
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.
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 presentations, compiling data, and authoring technical reports and regulatory filings associated with his/her work.
Effective communication skills are desirable for interactions with laboratory scientists, project managers and colleagues from numerous functions, serving on multi-disciplinary project teams.
Bachelor's Degree with in Pharmaceutics, Chemistry, Chemical/Biochemical Engineering, Pharmacy, Biochemistry or equivalent with 6+ years experience OR Master's Degree in Pharmaceutics, Chemistry, Chemical/Biochemical Engineering, Pharmacy, Biochemistry or equivalent with 4+ years experience.
3 years industrial experience in parenteral formulation and process development of protein, peptide, vaccine, viral vector, oligonucleotides, other biologic therapeutics.
Basic knowledge of protein or nucleic acid chemistry, degradation pathways, and stabilization techniques.
Excellent oral and written communication skills.
Knowledge of drug development processes for progression of a biological candidate.
Experience with analytical methods such as HPLC (SE-HPLC, IEX, RP-HPLC), Capillary Gel electrophoresis (CGE), imaged Capillary Electrophoresis (iCE), spectroscopy techniques
Familiarity with viral vectors for the delivery of therapeutic nucleic acids.
Familiarity with lyophilization and lyophilization cycle development.
Familiarity with parenteral manufacturing requirements, including media fills, environmental monitoring, container/closure integrity, and commercial unit operations.
Familiarity with GLP/GMP requirements.
Familiarity in scale-up and technology transfer to pilot/commercial scale.
Other Job Details:
Last Date to Apply for Job: October 31, 2020
Eligible for Employee Referral Bonus: YES
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