1+ months

Senior Scientist, Formulation Development

St Louis, MO 63103
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This position will be part of Pharmaceutical Research and Development. The incumbent will participate in the development, scale-up and transfer of parenteral formulations and manufacturing processes for various biologics modalities such as monoclonal antibodies, antibody drug conjugates, proteins and vaccines. 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.


The Senior Scientist, Biotherapeutics Pharmaceutical R&D (BTx PhRD), is a laboratory based position for performing formulation and manufacturing process development activities of therapeutic biologic drug products including cell and gene therapy, prophylactic and therapeutic vaccines as well as therapeutic protein-based modalities ranging from pre-clinical and Ph I clinical trials through commercialization. The position will involve use of innovative and modern techniques to develop and characterize dosage forms with appropriate stability profiles and develop associated manufacturing processes to meet project needs. 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 in accordance with ICH guidances Q8 and Q9. The incumbent will author written documentation and regulatory filings associated with his/her work, and will participate in technology transfer activities to manufacturing sites. The Senior Scientist, BTx PhRD, must be able to interact effectively with a multidisciplinary team of scientists and engineers for formulation and process optimization and overall product development. Effective communication skills are essential for interactions with laboratory scientists, project managers and colleagues from numerous functions, serving on multi-disciplinary project teams.


**Educational Background**


PhD. with 0-3 years, M.S.with 7+ years, or B.S. with more than 10 years of industrial experience in Pharmacy, Pharmaceutics, Biomedical Eng, Chemical Eng, Biochemistry, Biotechnology, Virology, Biology or equivalent.


PhD. with 0-3 years, M.S.with 7+ years, or B.S. with more than 10 years of industrial experience in Pharmacy, Pharmaceutics, Chemical Eng, Biochemistry, Biotechnology or equivalent. Experience in biologics or vaccines drug product development desired.

**Work Experience/skills**

Minimum: Newly qualified Ph.D. or 7+ years with M.S. or B.S with more than 10 years of industrial experience in formulation development, pharmaceutics, pharmacy, drug product manufacturing, and scale-up.

Desirable: Knowledge of drug development processes for progression of a biological candidate.

**Technical Skills**


+ Knowledge of process development and formulation techniques of any of the following:

+ cell and gene therapy

+ vaccine

+ oligonucleotide

+ Experience in biotherapeutic parenteral drug product formulation or process development of protein/peptide, vaccines or oligonucleotide therapeutics


+ Excellent oral and written communication skills and ability to mentor junior staff and peers across matrix teams

+ Leadership skills

+ Understanding of biophysical attributes of biotherapeutics

+ Knowledge of analytical and bio-analytical methods for biologics

+ Experience in vaccine formulation and process development

+ Experience in scale-up and technology transfer of aseptic processes to pilot/commercial scale manufacturing facilities

+ Theoretical and practical knowledge of lyophilization and lyophilization cycle development

+ Experience working with cells and virus

+ Solid understanding of thermodynamics and kinetics

+ Familiarity with GLP/GMP requirements

+ Experience in authoring regulatory submissions (IND, IMPD, BLA, MAA)

+ Familiarity with combination product development and design control

+ Experience in application of QbD concept in design, execution, and interpretation of formulation and process development experiments

+ Knowledge of ICH Q8 and Q9 guidance

+ Familiarity with Intellectual Property (IP)


The Senior Scientist will interact with:

+ Laboratory scientists

+ Colleagues from numerous functions on multidisciplinary projects

**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.

+ Eligible for Relocation Package: YES

+ Eligible for Employee Referral Bonus: YES


N (Other) (United States of America)

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Posted: 2019-08-16 Expires: 2020-02-20

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Senior Scientist, Formulation Development

St Louis, MO 63103

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