Senior Scientist, Formulation Development
- Employer
- Pfizer
- Location
- Chesterfield, Missouri
- Salary
- Competitive
- Closing date
- May 10, 2021
View more
- Discipline
- Health Sciences, Drug Development
- Position Type
- Full Time
- Job Type
- Senior Scientist
- Organization Type
- All Industry, Pharma
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ROLE SUMMARY
This position will be part of Pharmaceutical Research and Development which has developed formulations for advancing vaccines for deadly adolescent and adult infections including Meningococcal disease, Staphylococcus aureus and Clostridium difficile . The candidate will lead the formulation development, scale-up and transfer of vaccine modalities. This is a project-based position performing formulation and process development activities for vaccines from pre-clinical and Ph I clinical trials through manufacturing process performance qualification, license application and commercialization
ROLE RESPONSIBILITIES
The Senior Scientist, Biotherapeutics Pharmaceutical Research and Development is responsible for developing parenteral formulations, and tech transfer manufacturing processes to enable the successful development of novel antigen presenting technologies and adjuvant vaccine drug products. 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 vaccine 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 also responsible for executing new technologies and procedures to accelerate the biotherapeutic development v accine processes across projects.
BASIC QUALIFICATIONS
Minimum:
PREFERRED QUALIFICATIONS
PREFERRED QUALIFICATIONS
Other Job Details:
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
#LI-PFE
This position will be part of Pharmaceutical Research and Development which has developed formulations for advancing vaccines for deadly adolescent and adult infections including Meningococcal disease, Staphylococcus aureus and Clostridium difficile . The candidate will lead the formulation development, scale-up and transfer of vaccine modalities. This is a project-based position performing formulation and process development activities for vaccines from pre-clinical and Ph I clinical trials through manufacturing process performance qualification, license application and commercialization
ROLE RESPONSIBILITIES
The Senior Scientist, Biotherapeutics Pharmaceutical Research and Development is responsible for developing parenteral formulations, and tech transfer manufacturing processes to enable the successful development of novel antigen presenting technologies and adjuvant vaccine drug products. 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 vaccine 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 also responsible for executing new technologies and procedures to accelerate the biotherapeutic development v accine processes across projects.
BASIC QUALIFICATIONS
Minimum:
- B.S. in Pharmaceutics, Chemistry, Chemical/Biochemical Engineering,Pharmacy,Biochemistry,Bioengineering,Biotechnology,Biology, Biomedical engineeringand at least 9 years industry or equivalent experience.
- M.S. in Pharmaceutics, Chemistry, Chemical/Biochemical,Engineering,Pharmacy,Biochemistry,Bioengineering,Biotechnology,Biology, Biomedical engineeringand at least 7 years industry or equivalent experience.
- PhD. in Pharmaceutics, Chemistry, Chemical/Biochemical Engineering,Pharmacy, Biochemistry,Bioengineering,Biotechnology,Biology, Biomedical engineering.
PREFERRED QUALIFICATIONS
- B.S. with 9 or more years of industry experience in parenteral formulation andprocess development ofbiotherapeutics.
- M.S. with 7 or more years of industry experience in parenteral formulation andprocess development ofbiotherapeutics.
- PhD. with 1 to 3 years of industry experience in gene therapy formulation andprocess development ofbiotherapeutics.
PREFERRED QUALIFICATIONS
- Excellent leadership skills .
- Expert understanding and leadership of technical area necessary for biothera peutic 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) .
- 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 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
#LI-PFE
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