Senior Scientist – Drug Product Design and Development
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
This position will be part of Pharmaceutical Research and Development which is working on using genes as medicines to treat rare genetic diseases, is developing formulations for advancing vaccines for deadly adolescent and adult infections and is progressing antibody based therapies for rare diseases and oncology. 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.How You Will Achieve It
The Senior 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 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.
The candidate is also responsible for executing new technologies and procedures to accelerate the biotherapeutic development process across projects.QualificationsMust-Have
- Bachelor's Degree & 9+ years of relevant experience
- Master's Degree & 7+ years of relevant experience
- PhD & 0+ years of relevant experience
- Experience conducting solid state physical and chemical characterization of small molecules of pharmaceutical relevance, including particle characterization and solid state characterization
- Experience in one or more of the areas, including Formulation Development, Materials Science, Biopharmaceutics, Physical Chemistry
- Strong interest and motivation to learn new concepts is expected
- Good organizational skills, the ability to work independently, and excellent oral and written communication skills
- Strong written and oral communication skills and the use of MS Office
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.
Additional Posting Information
- Last Date to Apply for Job: November 1, 2021
- Eligible for Employee Referral Bonus
- Eligible for Relocation Package
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.Sunshine ActPfizer 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 EligibilityPfizer 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