Scientist - Biologics Drug Product Formulation & Process

About Pfizer
A career at Pfizer offers opportunity, ownership and impact. All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Role Description
This position will be part of Pharmaceutical Research and Development within BioTherapeutics Pharmaceutical Sciences. The Scientist will participate in the development of parenteral formulations for biologics modalities such as monoclonal antibodies, antibody drug conjugates, proteins, vaccines, cell-based therapies and viral vectors for genomic therapeutics. 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, and is responsible for data compilation, data presentations and report writing.
Responsibilities
The responsibilities of the Scientist position include but are not limited to: participate in developing parenteral formulations for biotherapeutic modalities such as monoclonal antibodies, antibody drug conjugates, proteins, vaccines, cell-based therapies and viral vectors for genomic therapeutics; 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), SDS-PAGE, 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. 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. Effective communication skills are desirable for interactions with laboratory scientists, project managers and colleagues from numerous functions, serving on multi-disciplinary project teams.
Qualifications
EDUCATIONAL BACKGROUND: MINIMUM: B.S. in Pharmaceutics, Chemistry, Chemical/Biochemical Engineering, Pharmacy, Biochemistry or equivalent with 6+ years experience DESIRABLE: M.S in Pharmaceutics, Chemistry, Chemical/Biochemical Engineering, Pharmacy, Biochemistry or equivalent with 4+ years experience 2. WORK EXPERIENCE/SKILLS: MINIMUM: 3 years industrial experience in parenteral formulation and process development of protein, peptide, vaccine, viral vector, cell-based or other biologic therapeutics. DESIRABLE: Knowledge of drug development processes for progression of a biological candidate. Technical Skills Requirements: MINIMUM: - Basic knowledge of protein or nucleic acid chemistry, degradation pathways, and stabilization techniques. - Excellent oral and written communication skills. DESIRABLE Technical skills: - Experience with protein analytical methods such as HPLC (SE-HPLC, IEX, RP-HPLC), SDSPAGE, 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.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.


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