Principal Scientist - Analytical Characterization

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

You will be responsible for supporting analytical characterization of viral vaccine strain change activities within the Vaccine Research and Development - Early Bioprocess Development group. You will lead the analytical team to support the DNA template, RNA drug substance and LNP drug product production and characterization to enable strain changes as required. You will provide leadership, scientific and technical support for the team of analytical scientists, as well as work with multifunctional teams outside of their reporting structure.

How You Will Achieve It

• Effectively plan for and execute timely analytical release and characterization of DNA template, RNA drug substance and LNP drug product to support viral vaccine strain change.
• Provide technical guidance to the analytical team to bridge and update analytical assays to support strain change activities.
• Plan and execute initial method performance evaluation using applicable guidelines with a high degree of independence.
• Lead the team in generating pAb critical reagents and establish material quality and assay suitability to support strain change activities.
• Partner with the Early Bioprocess development strain change team throughout the year to actively de-risk campaigns to deliver quality materials on-time and right first time. Communicates effectively to the stakeholders regarding potential delays or material quality issues.
• Publish all required documents (CoAs, updated analytical methods, method verification reports, etc.) to support the manufacturing campaigns.
• Provide management and supervision of colleagues, the group budget, laboratories, and compliance.

Qualifications

Must-Have

• PhD in Chemistry, Biochemistry, or a related discipline with a minimum of 4 years of related analytical chemistry experience in an academic, pharmaceutical, or biotechnology environment, or an MS with a minimum of 9 years of related work experience, or a Bachelor's Degree with a minimum of 12 years of related work experience.
• Biochemical, biophysical, and biological assay experience
• Experience overseeing the work of and training Scientists
• Strong verbal and written communication skills
• Strong documentation, technical writing and presentation skills

Nice-to-Have

• Experience releasing high quality materials in industry (pre-clinical, clinical, commercial)
• Experience leading a team
• Experience using analytical techniques to characterize DNA, mRNA or LNP and deep understanding of the quality attributes of an RNA LNP vaccine
• Working knowledge of establishing suitable polyclonal antibodies for assay use

PHYSICAL/MENTAL REQUIREMENTS

• Standard laboratory conditions - sitting, standing, primarily lab based
• Ability to perform mathematical calculations and ability to perform complex data analysis

Relocation support available

Work Location Assignment:On Premise

Relocation assistance may be available based on business needs and/or eligibility.

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

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