Hiring company: Pfizer
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
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. 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
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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.