Pfizer

Senior Scientist, Formulation Development

Posted on: 12 Feb 2021

St Louis, MO

Job Description

Why Patients Need You

Pfizers purpose is to deliver breakthroughs that change patients lives. Research and Development is at the heart of fulfilling Pfizers 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 youll find that everything we do, every day, is in line with an unwavering commitment to quality. This colleague will be part of the Pharmaceutical Research and Development team. In this role, you 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.

It is your dedication that will make Pfizer ready to achieve new milestones and help patients across the globe

How You Will Achieve It

The Senior Scientist 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

* Lead 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

* Lead the formulation and development activities from pre-clinical and Ph I clinical trials through commercialization

* Executing new technologies and procedures to accelerate the biotherapeutic development process across projects

Qualifications

Must-Have

* BS in Degree in in Pharmaceutics, Chemistry, Chemical/Biochemical Engineering, Pharmacy, Biochemistry, Bioengineering, Biotechnology, Biology, Biomedical engineering and 9+ years of industry or equivalent experience

* MS degree in the disciplines above and 7+ or PhD and 1+ years of industry or equivalent experience

Nice-to-Have

* Demonstrated industry experience in parenteral formulation and process development of biotherapeutic

* Demonstrated 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 as well as QbD concept in design, execution, and interpretation of formulation and process development experiments

* Working knowledge of GLP/GMP requirements

* Experience in authoring regulatory submissions (IND, IMPD, BLA, MAA)

* Ability to demonstrate autonomy in representing functional area

Other Job Details

* Eligible for Employee Referral Bonus

* LI-PFE

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 providers 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

Pfizer

New York, New York

Pfizer Inc. develops, manufactures, and sells healthcare products worldwide. It offers medicines and vaccines in various therapeutic areas, including internal medicine, vaccines, oncology, inflammation and immunology, and rare diseases under the Lyrica, Chantix/Champix, Eliquis, Ibrance, Sutent, Xalkori, Inlyta, Xtandi, Enbrel, Xeljanz, Eucrisa, BeneFix, Genotropin, and Refacto AF/Xyntha brands. The company also provides consumer healthcare products that comprise over-the-counter medicines, including dietary supplement products under the Centrum, Caltrate, and Emergen-C names; pain management products under the Advil and ThermaCare names; gastrointestinal products under the Nexium 24HR/Nexium Control and Preparation H names; and respiratory and personal care products under the Robitussin, Advil Cold & Sinus, and ChapStick names. In addition, it offers products that would lose or have lost marketing patent protection; branded generic products; generic sterile injectable products; biosimilars; and anti-infectives under the Lipitor, Premarin family, Norvasc, Lyrica, Celebrex, Viagra, Inflectra/Remsima, Zyvox, Vfend, Revatio, Inspra, Medrol, Sulperazon, Fragmin, Tygacil, Nivestim, and Retacrit, Ixifi Infliximab BS names.

Further, the company is also involved in the contract manufacturing business. It serves wholesalers, retailers, hospitals, clinics, government agencies, pharmacies, and individual provider offices, as well as disease control and prevention centers. The company has collaboration and/or co-promotion agreements with Bristol-Myers Squibb Company, Astellas Pharma US, Inc., and Oncolytics Biotech Inc.; licensing agreement with BionTech AG; strategic alliance with Verily Life Sciences LLC; and collaboration agreements with Pfizer, Merck & Co., Inc., and Eli Lilly & Company, as well as with Merck KGaA and Nektar Therapeutics to develop a therapy for treating pancreatic cancer. Pfizer Inc. was founded in 1849 and is headquartered in New York, New York.

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