Senior Scientist, Formulation

ROLE SUMMARY
This position will be part of Pharmaceutical Research and Development. The incumbent will participate in the development of parenteral formulation for biologics modalities such as monoclonal antibodies, antibody drug conjugates, proteins, vaccines, oligonucleotides, and viral vectors for genomic therapeutics. The incumbent will have a focus in the development of the dose preparation and handling instructions used by pharmacies and patients. This position will be responsible for performing analytical characterization of candidate molecules by using various biophysical and biochemical characterization techniques. Furthermore, this position will assist in developing processes for drug product manufacturing, responsible for data compilation, data presentations and report writing and gain understanding of how pharmacies prepare investigational and commercial products. This colleague will have an opportunity to work at the interface between various departments.

ROLE RESPONSIBILITIES

• The incumbent will assist in the development of dosage and administration instructions, responding to clinical and commercial queries relevant to dosing and handling, understanding and implementing current and future clinical guidance's.
• The Senior Scientist must be able to interact effectively with a multi-disciplinary team of scientists across departments/groups for the overall clinical and commercial development of overall pipeline.
• Participate in developing parenteral formulations for biotherapeutic modalities such as monoclonal antibodies, antibody drug conjugates, proteins, vaccines, oligonucleotides, and viral vectors for genomic therapeutics. 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), SDSPAGE, 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 drug product processes from bench top to pilot scale and, as required, technology transfer to commercial plants. Examples of drug product processes are fluid transport, sterilizing filtration and lyophilization.
• 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.
• Mentoring colleagues.

BASIC QUALIFICATIONS

• PhD with 0-3 years of experience, Master's Degree with 4-8 years of experience or Bachelor's Degree with 9+ years of experience with a degree in Pharmaceutics, Chemistry, Chemical/Biochemical Engineering, Pharmacy, Biochemistry, or closely related field
• Excellent verbal and written communication skills are required.
• Strong leader behaviors and the ability to collaborate and mentor others.
• Experience in parenteral formulation and process development of protein, peptide, vaccine, viral vector, or other biological therapeutics.
• Strong working knowledge of the drug development process for the progression of biological therapeutics. Experience with biotherapeutics analytical methods such as HPLC (SE-HPLC, IEX, RP-HPLC), SDS-PAGE, Capillary Gel electrophoresis (CGE), imaged Capillary Electrophoresis (iCE), spectroscopy techniques
• Self-motivated and able to work effectively as part of a cross-functional team.
• Ability to multitask priorities to align with project objectives.

PREFERRED QUALIFICATIONS

• Familiarity with dosing and handling administration techniques.
• Familiarity with clinical pharmacy guidance's/practices.
• Excellent documentation skills.
• Familiarity with GMP requirements.
• Working knowledge of HPLC (SE-HPLC, IEX, RP-HPLC), SDS-PAGE, Capillary Gel electrophoresis (CGE), imaged Capillary Electrophoresis (iCE), spectroscopy techniques is highly desirable.

OTHER DETAILS

• Last Date to Apply: November 25, 2020
• Eligible for Employee Referral Bonus: Yes
• #LI-PFE

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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.

Research and Development