The primary purpose of this position is to develop analytical assays for protein and conjugate vaccine antigens. Under the supervision of the manager, the incumbent will be responsible for the execution of method qualification and method transfer in support of vaccine materials release and stability testing for early phase vaccine programs. Assays of primary responsibility will include separation-based and spectroscopic-based techniques. Work is expected to be done in a compliant manner according to SOPs and GLP guidelines when applicable.ROLE RESPONSIBILITIES
- This individual should be able to provide hands on experimental support to develop robust analytical assays. This individual should be familiar with basic regulatory expectations around product control strategies and the ICH guidelines for method qualification.
- In this position, the individual will contribute to the design, plan, and execute assay development, qualification and transfer studies to support the release, stability, and characterization of vaccine drug substances and drug products (GLP).
- The candidate will be expected to provide routine sample analysis to support process and formulation development activities. The individual is expected to analyze and interpret experimental data, and provide conclusions.
- The candidate is expected to manages own time to meet agreed targets, and develops plans for short-term work activities on own projects (timelines, work plans, deliverables)
- In this position, the individual is expected to effectively collaborate with colleagues within Vaccine Research and Development Early Bioprocess, Analytical, and Formulation Development (VRD-EBPD) and appropriate partner lines. They will be expected to share and present their work in relevant project based meetings and to author appropriate documents.
- The individual is expected to manage daily, weekly and monthly laboratory activities, such as monitoring of equipment, completion and review of equipment logbooks, periodic laboratory cleaning and managing the laboratory waste, checking PMO status of lab equipment and resolving discrepancies. Manage storage of reagents and test solutions in accordance with departmental procedures.
EEO & Employment Eligibility
- MS in Chemistry, Biochemistry, or related discipline with at least 2 years of academic, pharmaceutical, or biotechnology postdoctoral experience or a BS plus 4 years of related work experience is required. Experience in vaccine analytical assay development is a major plus.
- A strong background in separation-based analytical techniques and qualification using ICH guidelines is essential. Experience with applying these methodologies for biomolecules, such as proteins and conjugates 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.
- Ability to write technical documents, including but not limited to method SOPs, development reports, qualification reports, method transfer protocols and method transfer report.
- Proficiency with personal computers including word processing, spreadsheets, PowerPoint and relevant scientific software is desirable. Strong verbal and written communication skills are required.
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.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.Other Job Details:
- Last Date to Apply for Job: April 30, 2018
- Eligible for Employee Referral Bonus
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.