Pfizer

Principal Scientist, Formulation

Employer
Pfizer
Location
Chesterfield, Missouri
Salary
Competitive
Posted
November 16 2020
Ref
4794880
Position Type
Full Time
Organization Type
Pharma
ROLE SUMMARY

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 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.

ROLE RESPONSIBILITIES

The 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.

BASIC QUALIFICATIONS
  • PhD., M.S. with 5 or more years or more industrial experience, or Bachelor's/Master's Degree with 10 or more years of industrial experience in Pharmacy, Pharmaceutics, Biomedical Eng, Chemical Eng, Biochemistry, Biotechnology, Virology, Biology or equivalent scientific field.
  • Experience in formulation development, pharmaceutics, pharmacy or drug product manufacturing or scale-up of biotherapeutics modalities
  • Experience in biotherapeutic parenteral drug product formulation or process development of protein or gene therapy or vaccines.


PREFERRED QUALIFICATIONS
  • PhD., M.S. with 5 or more years industrial experience, or B.S. with 10 or more years of industrial experience in biotherapeutic formulation development and scale up.
  • Experience in leading teams associated with formulation development, pharmaceutics, pharmacy, drug product manufacturing, and scale-up of gene therapy modalities through regulatory filing and commercial launch.
  • 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.
  • Demonstrates ownership and can see things through (end-to-end).
  • Sound understanding of when decisions should be made / elevated.
  • Demonstrates One Pfizer behavior
  • Conceives and drives line initiatives, technology development and CMC strategy.
  • Serves as a mentor and demonstrates ability to serve as a role model.
  • Influences lines outside of Pharmaceutical Research and Development - can devise and explain strategy, concepts and complex technology to experts and non-experts alike.
  • Builds effective relationships with cross-functional Pfizer customers (e.g., listening skills, demonstrates empathy, conflict resolution).
  • Benchmarks and stays current with external publications, conferences or meetings.
  • Scientific contributions recognized outside of Pharmaceutical Research and Development; increased external influence (e.g,. publication, consortium, regulatory influence).


Other Job Details:
  • Last Date to Apply for Job: November 27, 2020
  • Eligible for Relocation Package: YES
  • Eligible for Employee Referral Bonus: YES


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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

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