Pfizer

Scientist, Formulation

Employer
Pfizer
Location
Andover, Massachusetts
Salary
Competitive
Posted
November 16 2020
Ref
4789709
Position Type
Full Time
Organization Type
Pharma
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.

ROLE RESPONSIBILITIES

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.

BASIC QUALIFICATIONS
  • 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.


PREFERRED QUALIFICATIONS
  • Knowledge of drug development processes for progression of a biological candidate.
  • Experience withanalytical 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.


ADDITIONAL OFFER DETAILS
  • 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.

Research and Development

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