1+ months

Senior Scientist, Formulation Development

Pfizer
St Louis, MO 63103
**Wh** **y Patients Need You**



Pfizer's purpose is to deliver breakthroughs that change patients' lives. Research and Development is at the heart of fulfilling Pfizer's purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best in class medicines to patients around the world.



**What You Will Achieve**



As a Senior Scientist, you will be at the center of our operations and you'll find that everything we do, every day, is in line with an unwavering commitment to quality. You will be part of the Pharmaceutical Research and Development team that is focusing on utilizing genes as medicines to treat rare genetic diseases. The candidate will lead formulation development, scale-up, and transfer of gene therapy adeno associated virus (AAV) modalities. This is a project-based position performing formulation and process development activities for gene therapies from pre-clinical and Ph I clinical trials through manufacturing process performance qualification, license application and commercialization. You will be recognized as a technical expert and a scientific contributor. With your deep knowledge of the discipline, your decisions will impact the success of projects. You will be a critical member of our team developing formulations that ensure the stability of AAV-based therapeutics. You will be using your scientific judgment to adapt standard methods and techniques by applying prior work experience. You will be forecasting and planning resource requirements for your project team. Your creativity in developing novel processes and new ideas will be used frequently. You will undertake mentoring activities to guide team members. It is your innovative scientific temperament that will help in making Pfizer ready to achieve new milestones and help patients across the globe.



**How You Will Achieve It**



+ Contribute and influence at the project team level.

+ Interface with, provide formulation knowledge and expertise, and communicate the interpretation and implication of results to drug discovery teams and Pharmaceutical Science project teams.

+ Conduct solid state physical and chemical characterization of small molecules of pharmaceutical relevance, including particle characterization and solid state characterization.

+ Lead and plan formulation/process development assignments and activities to meet established project goals and timelines.

+ Maintain an awareness of and contribute to current scientific literature.



**Qualifications**



**Must-Have**



Minimum:



+ B.S. in Pharmaceutics, Chemistry, Chemical/Biochemical.

+ Engineering, Pharmacy, Biochemistry, Bioengineering, Biotechnology, Biology, Biomedical engineering and at least 9 years industry or equivalent experience.

+ M.S. in Pharmaceutics, Chemistry, Chemical/ Biochemical, Engineering, Pharmacy, Biochemistry, Bioengineering, Biotechnology, Biology, Biomedical engineering and at least 7 years industry or equivalent experience.

+ PhD. in Pharmaceutics, Chemistry, Chemical/Biochemical Engineering, Pharmacy, Biochemistry, Bioengineering, Biotechnology, Biology, Biomedical engineering.



**Nice-to-Have**



+ B.S. with 9 or more years of industry experience in parenteral formulation and process development of biotherapeutics.

+ M.S. with 7 or more years of industry experience in parenteral formulation and process development of biotherapeutics.

+ PhD. with 1 to 3 years of industry experience in gene therapy formulation and process development of biotherapeutics.



**Preferred qualifications**



+ 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) .

+ 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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Posted: 2021-03-29 Expires: 2021-05-28

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Senior Scientist, Formulation Development

Pfizer
St Louis, MO 63103

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