Team Lead - GMP Manufacturing
Job Description
Why Patients Need You
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 Team Lead - GMP Manufacturing is a position within the St. Louis Clinical Manufacturing Facility (SCMF) organization responsible for on the floor leadership and functional management for all areas of operation within the SCMF space. The SCMF is responsible for manufacture of clinical starting materials and Drug Substance derived from microbial and mammalian culture processes.
This position leads technical operations within SCMF during the 3rd shift and will work closely with other members of the SCMF Manufacturing ELT to ensure timely delivery of supply and process scale up commitments.
This position is responsible for identifying operational efficiency improvements and planning and implementing those improvements within the operational area. Must be capable of implementing change to the manufacturing infrastructure to ensure area operational success. Responsible for coaching and developing staff, identifying growth opportunities and mentoring so that all staff can realize their full potential.
How You Will Achieve It
Accountable for operational deliverables across SCMF GMP manufacturing.
Works across areas to integrate manufacturing activities to meet demanding development timelines and objectives and works with other area leaders to ensure that high quality, timely, and achievable project objectives are established and communicated.
Provides a mature and experienced operations perspective for multiple unit operations supporting clinical manufacturing and process scale up approaches.
Broad general knowledge of all unit operations performed in the manufacturing facility.
Ability to guide junior engineers and technicians to make correct decisions during the course of daily operations.
Sets departmental standards that encourage self-motivation and flawless execution with the goal of continuous improvement.
Responsible for planning and developing staff, identifying growth opportunities and mentoring so that all staff can realize their full potential, as well as addressing performance issues appropriately.
Works with the SCMF Operations group to support investigations, validations, and GMP documentation requirements as needed.
Interacts with the Quality Assurance group on a regular basis to ensure adherence to Pfizer standards of GMP manufacturing
BASIC QUALIFICATIONS
Must Have
B.S./M.S. in Chemical/Biochemical Engineering, or Cell Biology, Biochemistry, Microbiology and 3+ years of industry experience.
Extensive practical knowledge in a wide variety of heterologous expression systems with a focus on E. coli and CHO cells - OR - Experience executing relevant recovery and purification processes derived from microbial and/or mammalian production cultures.
2+ years of demonstrated supervision/leadership of operations staff.
3+ years of GMP manufacturing experience.
Excellent oral and written communication skills.
Nice to Have
Direct or matrix management and project management training/experience.
Experience in supporting the scale-up and tech transfer from development laboratory to clinical manufacturing.
PHYSICAL/MENTAL REQUIREMENTS
Must be able to lift 40 lbs and work in a clean room environment.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
3rd Shift Schedule (11:30 PM - 8 AM) - may also work 10-hour days 4 days a week
PHYSICAL/MENTAL REQUIREMENTS
Must be able to lift 40 lbs and work for extended periods without sitting.
Other Job Details
- Last day to apply: November 6, 2024.
- Work Location Assignment:On Premise.
The annual base salary for this position ranges from $88,300.00 to $147,100.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 12.5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
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. This position requires permanent work authorization in the United States.
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.
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