Senior Scientist - Drug Product Design and Development

Why 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

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 includinggene therapies,prophylactic and therapeuticvaccines 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 andPhaseIclinical trials through commercialization.

The candidate is also responsible for executing new technologies and procedures to accelerate the biotherapeutic development process across projects.

Qualifications

Must-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

Nice-to-Have

• 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: October 1, 2021
• Eligible for Employee Referral Bonus
• Eligible for Relocation Package
• #LI-PFE

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 Act

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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

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