Senior Associate 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 mRNA, LNPs, monoclonal antibodies, proteins, vaccines, and viral vectors for genomic therapeutics. 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.

ROLE RESPONSIBILITIES

The responsibilities of Senior Associate Scientist position include but are not limited to :

• Participate in developing parenteral formulations for biotherapeutic modalities such as mRNA, monoclonal antibodies, proteins, vaccines, 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 Fragment analyser, ribogreen assays, 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 Senior Associate Scientist 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.
• The Senior Associate 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.

BASIC QUALIFICATIONS

• MS degree in appropriate Science & Engineering discipline, with 0-2 years of r ele vant experience in parenteral formulation and process development of protein/peptide/DNA/vaccine therapeutics in the biopharmaceutical industry. or BS degree in appropriate Science & Engineering discipline, with a minimum of 2-4 years of relevant experience in parenteral formulation and process development of protein/peptide/DNA/vaccine therapeutics in the biopharmaceutical industry.
• Examples of appropriate Science & Engineering disciplines include Pharmaceutics, Pharmacy, Chemistry, Biochemistry, Chemical/Biochemical Engineering, or other related discipline
• Experience with biotherapeutics characterization methods such as HPLC (SE-HPLC, IEX, RP-HPLC), Fragment analyser, ribogreen assays, SDS-PAGE, Capillary Gel electrophoresis (CGE), imaged Capillary Electrophoresis (iCE), Spectroscopy techniques such as UV and Fluorescence spectroscopy, Circular Dichroism and FTIR.
• Demonstrated scientific documentation skills

PREFERRED QUALIFICATIONS

• Knowledge of drug development processes for progression of a biological candidate.
• Experience with parenteral drug product processes/unit operations such as buffer exchange, filtration, filling, lyophilization and lyophilization cycle development
• Experience with parenteral manufacturing requirements, container/closure integrity, and clinical and commercial unit operations.
• Knowledge of GMP requirements.

Other Job Details:

• Last Date to Apply for Job:May 14, 2019
• Additional Location Information: Andover, MA
• Eligible for Employee Referral Bonus: Yes

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

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.

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

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

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