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. ROLE RESPONSIBILITIES
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 PhaseI 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. BASIC QUALIFICATIONS
- 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.
Other Job Details:
- 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.
- Eligible for Employee Referral Bonus: YES
- Eligible for Relocation: YES
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