Address
Form of work
SalaryWhy 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 innovative and customer oriented. Whether you are involved in manufacturing, testing, or compliance, your contribution will directly impact patients.
What You Will Achieve
Responsible for planning and coordinating various Manufacturing activities with Process Engineers, Supervisors, and Managers involving multiple site Manufacturing departments.
Duties include managing Manufacturing cGMP documentation system, planning and scheduling batch/buffer activities to support multiple clinical/commercial Manufacturing operations, project manage special projects and manage cGMP sampling plans to support clinical/ commercial programs, products, and projects. Acts as a department liaison between Quality Assurance (QA), Technical Operations, and Site Engineering and Maintenance in planning of batch/buffer preparation, managing cGMP documentation, creation and management of cGMP sampling plans, and equipment maintenance activities involving multiple Manufacturing departments. Proficient at maintaining Manufacturing inventory for consumable items and orders essential non-standard production items using Pfizer enterprise systems.
How You Will Achieve It
- Lead and manage batch/buffer preparation activities to support clinical/commercial Manufacturing involving multiple areas/products.
- Utilize automated systems to plan and monitor production activities (LIMS, Delta V, MES, SAP).
- Interface with management and team leads across Manufacturing departments and Technical Operations to optimize Manufacturing operations schedule based on upstream/downstream processing requirements, equipment, and staffing constraints.
- Re-prioritize and schedule production activities when unplanned disruptions occur in 24x7 operations.
- Decisions must be timely and minimize disruptions to multiple clinical and commercial biologics production areas with limited/shared resources.
- In addition, responsible to lead/facilitate the weekly production planning meeting to ensure the day to day operational plan is communicated and successfully executed.
- Proactively identify and escalate to senior management unplanned programs and projects that disrupt planned production activities in multiple vaccine programs.
- Coordinate the issuance, tracking, and review of batch records and other controlled documents to ensure target product-based cycle times are met. Complete batch scaling calculations in master batch records and author cGMP documents as required to meet plan of record. Strong understanding of cGMPs to assist in the review of Manufacturing records for completeness and accuracy. Support programs and projects that require Manufacturing input/resources.
- Prepare and place purchase orders for supplies and materials necessary for Manufacturing. Resolve invoice, receiving problems, and expediting of orders. Manage and optimize IMEx systems that impact consumables/disposables required for clinical and commercial Manufacturing operations.
- Lead and manage projects and programs that impact production plan of record as assigned by management. Upon assignment of the project/objective, develop an action plan/schedule, present updates, implement, and verify achievement of project objective.
- Train and develop new Manufacturing Planners in area of expertise. Demonstrate proficiency in other Manufacturing areas to backfill and support based on business needs.
Qualifications
Must-Have
- Applicant must have HS Diploma with 6 years of relevant experience; OR an Associate's degree with 4 years of experience; OR a Bachelor's degree with 0-2 years of experience
- Experience with quality records (i.e., batch records, procedures, forms, etc.)
- Work independently as well as in team environment
- Strong communication skills
- Planning and coordinating various Manufacturing activities across multiple areas
- Maintaining Manufacturing inventory for consumable items
- Operations planning and scheduling experience (SAP, Microsoft Project, Word and Excel)
- Purchasing experience
- Mathematical calculating
Nice-to-Have
- Perform complex data analysis with Process Engineers and/or Managers
- Project Management
Physical/Mental Requirements
- Lifting of boxes
- Traveling between buildings on the Sanford campus
Non-Standard Work Schedule, Travel, or Environment Requirements
- This role is standard day Monday through Friday work shift; some off-shift support needed when issues arise.
Other Job Details
- Last day to Apply: March 25th, 2024
- Eligible for Employee Referral Bonus: NO
- Eligible for Relocation Assistance: NO
Work Location Assignment: On Premise
The annual base salary for this position ranges from $64,600.00 to $107,600.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 7.5% of the base salary. 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.
