1+ months

Senior Principal Scientist , Group Lead

St Louis, MO 63103
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This position will be part of Pharmaceutical Research and Development. The candidate will lead the development,

scale-up and transfer of parenteral formulations and manufacturing processes for various biologics modalities such as gene

therapies, monoclonal antibodies, antibody drug conjugates, proteins and vaccines. This is a project and people leadership-based position performing formulation and process development activities for biotherapeutic molecules from pre-clinical and Ph I clinical trials through manufacturing process performance qualification, license application and commercialization.

The Senior Principal Scientist,BiotherapeuticsPharmaceutical Research and Developmentwill be responsible for the performance and development of 6-8 colleagues within the group. The candidate will be a member of the leadership team and help influence the formulation and process development strategies across the portfolio.

The Senior Principal Scientist, Biotherapeutics Pharmaceutical Research and Development is responsible for developing parenteral formulations, alternate drug delivery systems, and tech transfer manufacturing processes to enable the successful development of biotherapeutic drug products includinggene therapies,prophylactic and therapeuticvaccines and protein-based modalities. The position will involve leading a technical project team that will apply characterization and stability information to develop an appropriate dosage form to meet clinical and commercial needs. The position is responsible for leading the formulation and development activities from pre-clinical andPhIclinical trials through commercialization.

The candidate is responsible for developing/identifying new technologies and procedures to accelerate the biotherapeutic development process across projects.

**Educational Background:**


+ PhD., M.S. with 8-12 years industrial experience, or B.S. with 12 or more years of industrial experience in Pharmacy, Pharmaceutics, Biomedical Eng, Chemical Eng, Biochemistry, Biotechnology, Virology, Biology or equivalent scientific field.


+ PhD., M.S. with 8-12 years industrial experience, or B.S. with 12 or more years of industrial experience in biotherapeutic formulation development and scale up.

**Work Experience/skills:**


+ Experience in formulation development, pharmaceutics, pharmacy or drug product manufacturing or scale-up ofbiotherapeutics modalities.


+ Experience in leading teams associated with formulation development, pharmaceutics, pharmacy, drug productmanufacturing, and scale-up of gene therapy modalities through regulatory filing and commercial launch.


+ Experience in biotherapeutic parenteral drug product formulation or process development of protein or gene therapy or vaccines.

+ Experience in leading multidisciplinary technical teams.

+ Experience in responsibility for performance and development of direct reports.

+ Working knowledge of regulatory filing process.


+ Excellent oral and written communication skills.

+ Experience in leading and developing direct reports and peers across matrix teams.

+ Excellent leadership skills

+ Expert understanding and leadership of technical area necessary for biotherapeutic molecule formulation development.

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

+ Solid understanding of thermodynamics and kinetics

+ Working knowledge of GLP/GMP requirements Experience in authoring regulatory submissions (IND, IMPD, BLA, MAA)

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

**"Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve** **meaningful outcomes and create business impact."**

**Other Job Details:**

+ Eligible for Relocation Package: YES

+ 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
Posted: 2021-04-14 Expires: 2021-06-28
Sponsored by:
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Senior Principal Scientist , Group Lead

St Louis, MO 63103

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