Manager Lab Operations, PCR
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.What You Will Achieve
The Quality Control Microbiology group is seeking a highly motivated candidate to provide oversight and support to a team focused on PCR-based methods for new products, including mRNA vaccines. The incumbent will oversee a group of direct reports responsible for PCR-based methods for drug substance and drug product samples. The manager will also be responsible for review/approval of investigations, change controls, commitments, and documents and may conduct data review and sample approval activities.
Responsibilities also include ensuring audit readiness, laboratory safety, and compliance to procedures, Pfizer Quality Standards, and regulatory requirements. The incumbent will be responsible for planning and scheduling work to align with company goals and to provide leadership and expertise for areas of oversight in both internal and external audits. The incumbent will lead and develop their team, and work with the team to support continuous improvement initiatives.
- Ensure all aspects of testing (e.g. testing and data review) are planned, scheduled and conducted to meet required timelines.
- Review and approval of GMP documentation such as data, reports, procedures.
- Oversight and review/approval of investigations, CAPAs and change controls. Ensure agreed upon timelines are met.
- Provide leadership and direction to a team of 6-10 analysts with varying levels of experience (both full time employees and contractors). Coach, mentor and develop staff.
- Ensure alignment to all regulations and Pfizer Quality Standards related to area of oversight.
- Responsible for working with other management across QCM and QC
- Responsible to represent their area of oversight in internal and external audits.
- Promote and deliver continuous improvement both in area of oversight and in the QCM department and Quality Organization.
- Accountable for laboratory safety practice adherence.
- Represent the area oversight at meetings and huddles and may represent QC Microbiology as needed.
- Develop and support a continuous improvement culture and oversee/guide staff on CI tools.
- B.S. in microbiology with a minimum of 10 years experience in a GMP regulated environment with 5+ years' experience in aleadership/managementrole within a GMP regulated QC laboratory
- Knowledge and practical application of relevant techniques – PCR based assays and methodology.
- Experience with performing PCR based assay is required.
- Knowledge of GMP compliance requirements for Quality Control Laboratories
- Demonstrated skills in collaboration, attention to detail, and communication skills (written and oral)
- Solid understanding of continuous improvement, and development and/or implementation of best practices in Quality Control Laboratories is required
NICE TO HAVE
- Experience with instrument and method validation is desired.
- Experience with method transfer is desired.
- Experience with LWLIMS, QTS and PDOCs is a plus
Work Location Assignment:Flexible
Normal lifting, sitting, standing and walking requirements to facilitate support of staff in the office and on the floor (laboratory).
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Position is first shift Monday through Friday. Some off hour (night/weekend/holiday) support may be required.
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.
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.Quality Assurance and Control#LI-PFE