The candidate will develop analytical assays and design, plan and execute the qualification and transfer of these assays in support of Vaccine development, including materials release and stability for early phase vaccine programs. The focus of this position is for assay development for nucleic acid and nucleic acid lipid delivery platform formulations utilizing standard analytical techniques such as HPLC, CE, UV-Vis, Mass Spectrometry and other applicable techniques.
- The individual should be able to identify key Vaccine drug substance and drug product attributes and provide hands on support to develop robust assays for routine use with a focus on nucleic acid vaccines
- The individual should be familiar with basic regulatory expectations and the ICH guidelines for method qualification
- Contribute to the selection of the methodology and techniques to be used
- Independently analyze, interpret, provide conclusions and present experimental data internally
- Perform routine sample analysis
- Independently design, plan, and execute assay development, qualification and transfer studies to support the release, stability and characterization of vaccine candidates
- Collaborate with colleagues within Vaccine Research and Development – Bioprocess, Analytical, and Formulation Development and appropriate partner lines
- Author and review laboratory methods and reports
- Keep abreast of scientific/ technological development by participating in scientific meetings/ seminars and through regular scientific review
- As needed, introduce and utilize new technologies and establish those technologies to characterize the vaccines under development Where applicable, perform job responsibilities in compliance with GLP and all other regulatory agency requirements
- PhD in Chemistry, Biochemistry, or related discipline with at least 2 years of academic, pharmaceutical, or biotechnology postdoctoral experience or an MS plus 7 years of related work experience is required.
- Experience in analytical assay development for nucleic acid and nucleic acid lipid delivery platform is essential.
- A strong background in separation-based analytical techniques and method qualification using ICH guidelines is essential. Experience with applying these methodologies to biomolecules, such as nucleic acid is preferred. Proficiency and ability to utilize techniques such as HPLC, CE, and UV-Vis to develop methods to analyze potential vaccine antigens and other vaccine components.
- Proficiency with personal computers including word processing, spreadsheets, PowerPoint and relevant scientific software is desirable. Strong verbal and written communication skills are required.
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.
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.
Other Job Details:
- Eligible for Relocation Package
- Eligible for Employee Referral Bonus