Scientist, Biotherapeutics Pharmaceutical R&D

Pfizer Inc. is seeking a Scientist, Biotherapeutics Pharmaceutical R&D (BTx PhRD) in Andover, MA.

Participate in the development of parenteral formulations for biologics modalities such as monoclonal antibodies, proteins, vaccines, and viral vectors for genomic therapeutics. Perform formulation and manufacturing process development activities for therapeutic biologic products, including gene therapy, prophylactic and therapeutic vaccines as well as therapeutic protein-based modalities ranging from pre-clinical and Ph I clinical trials through manufacturing process performance qualification, license application and commercialization. Perform analytical characterization of candidate formulations by using various biophysical and biochemical characterization techniques. Assist in developing processes for drug product manufacturing. 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. 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 technology transfer to manufacturing plants. Prepare data summary presentations, compile data, and author technical reports and regulatory filings.

Requires: Master's degree (or foreign equivalent) in Pharmaceutics, Chemistry, Chemical Engineering, Biochemical Engineering, Pharmacy, or Biochemistry plus 4 years of experience in job offered or as Research Associate/Senior Research Associate OR a combination of a Bachelor's degree in stated fields plus 6 years of experience or any suitable combination of education, training and/or experience. Also requires 3 years of industry experience with/using the following (which may have been gained concurrently):

• HPLC, Dissolution Apparatus, DSC, NIR, pH, GC, FTIR, SEM and Empower.
• Participate in developing characterization methods for drug substances and drug products for various modalities.
• Work with analytical chemistry, degradation pathways, and design of stability studies.
• Develop analytical methods such as HPLC (IEX, SEC, RP-HPLC), and spectroscopy techniques such as NIR and FTIR.
• Design dissolution studies to evaluated efficacy of drug products such capsules and tablets.
• Develop a fiber optic probe method to track dissolution of drug product in real time.
• Design and execute forced degradation and stability studies to evaluate stability of drug products in various container closure systems.
• Troubleshoot gel formation issue and develop a characterization method using SEM to study the impact of buffer on gelled state of drug substance.
• Contribute towards selection the appropriate formulation, process design, scale up approaches, identify critical parameters by presenting analytical data to key stakeholders.
• Document experiments and results in electronic notebook in accordance to GLP.
• Support authoring of reports and responses regulatory queries and IND/NDA filings.

To apply, go to https://pfizer.wd1.myworkdayjobs.com/PfizerCareers. Scroll down, click "Search jobs," enter "4895291" as the "Keyword," and click "Search." No calls please.

Note: Salary $109,544.00.00 per year

Relocation assistance may be available based on business needs and/or eligibility.

Sunshine Act

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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