Pfizer Senior Scientist, Formulation Development in St. Louis, Missouri
This position will be part of Pharmaceutical Research and Development. The candidate will serve as a subject matter expert in lyophilization process and formulation design and optimization. As part of this role, they will also lead the development, scale-up and transfer of lyophilized parenteral formulations and m anufac turing processes for various biologics modalities such as gene therapies, monoclonal antibodies, antibody drug conjugates, proteins and vaccines.
The Senior Scientist, Lyophilization Formulation & Process Development is responsible for developing lyophilized parenteral formulations, alternate drug delivery systems, and tech transfer manufacturing processes to enable the successful development of biotherapeutic drug products including gene therapies, prophylactic and therapeutic vaccines and protein-based modalities. The position will involve leading a technical project team inside and outside the lab 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 and Phase I clinical trials through commercialization.
As a subject matter expert in lyophilization, the candidate is also responsible for assessing and developing alternative drying technologies for application to sterile injectable products.
B.S. in Chemical or Biochemical Engineering, Pharmaceutical Sciences, Biomedical Engineering or a related field, and 5-8 years industry or equivalent experience.
M.S. in Chemical or Biochemical Engineering, Pharmaceutical Sciences, Biomedical Engineering or a related field, and 3-6 years industry or equivalent experience.
PhD. in Chemical or Biochemical Engineering, Pharmaceutical Sciences, Biomedical Engineering or a related field.
B.S. with 5 or more years of industry experience in lyophilized parenteral and process development of biotherapeutics.
M.S. with 3 or more years of industry experience in lyophilized parenteral and process development of biotherapeutics.
PhD. with 1 to 3 industry experience in lyophilized parenteral and process development of biotherapeutics.
The preferred qualifications of Scientist position include but are not limited to:
Excellent leadership skills.
Expert understanding and leadership of lyophilization process and formulation development for biotherapeutics.
Experience in scale-up and technology transfer of aseptic manufacturing processes, including lyophilization, 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) .
Solid understanding of QbD concept in design, execution, and interpretation of formulation and process development experiments.
Ability to demonstrate autonomy in representing functional area.
Communicates well in written form and verbally across functional areas and large groups.
Other Job Details:
Eligible for Employee Referral Bonus: YES
Eligible for Relocation: YES
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Research and Development