• Job Description

  Req#: 4899583

  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 innovative and customer oriented. Whether you are involved in manufacturing, testing, or compliance, your contribution will directly impact patients.

  What You Will Achieve

  You will be a member of Pfizer’s dedicated and highly effective Quality Control Team. As a Technical Manager QC Microbiology, you will provide microbiological subject-matter expertise and support a team of microbiologists responsible for microbiological testing activities associated with the manufacturing operations in the Sanford Vaccines and Gene Therapy programs. Major responsibilities will include troubleshooting microbiological assays, providing subject matter expertise during investigations, supporting audits and inspections, ensuring testing is scheduled, performed, reviewed, and approved to meet manufacturing, disposition, and supply needs; and liaising with operations, QA, and other stakeholders on testing status and results. This is an individual contributor role.

  How You Will Achieve It

  • Recognized as a Subject Matter Expert having extensive technical knowledge of microbiological assays and instrumentation used within QC Microbiology

  • Supports cell banking and associated testing activities.

  • Supports audits and inspections; reviews/approves technical content ensuring both scientific merit and compliance to regulatory agency regulations and Pfizer policy and standards

  • Manages multiple projects/ongoing work activities (timelines, work plans, project deliverables) of moderate complexity .

  • Can execute work independently and make decisions with incomplete instructions/information.

  • Can lead teams through ambiguous situations.

  • Responsible for knowing, understanding, and acting in accordance with Pfizer’s values.

  • Encourages accountability and ownership.

  • Ensures team is operating in a manner consistent with cGMPs.

  • Knows and follows all EH&S safety requirements for site and QC laboratories; leads safety initiatives and encourages others to act safely

  • Excellent written and verbal communication and interpersonal skills; established relationships within business lines

  • Identifies issues, presents complex problems with possible solutions, and actively takes leadership role to resolve

  • Receives and acts on feedback from management and other colleagues, takes accountability for actions and personal development

  • Engages with a wide range of co-workers, customers and management within the Network to gather the input and background knowledge needed to complete assignments

  • Consistent correctness and accuracy in tasks, activities, decisions, and documentation; detail oriented behavior

  • Good judgment and correct decision making based on expert knowledge of Pfizer procedures, policy and standards; quality systems knowledge; technical experience; and industry guidance / regulatory authority regulations

  • Decision making that includes impact awareness on future quality and compliance as well as impact on own work group, department, and site

  • Represents Quality Control on site and network teams/forums/summits that support sustaining or improving site or network operations; influences and negotiates with business lines and shares information obtained with Quality Operations

  • Acts as an influential change agent fostering continuous improvement behaviors in others

  • Proactively identifies, takes remedial action, and/or seeks advice when a personal, project, team, department, or Network goal/deliverable is off schedule

  • Delivers large and complex high business impact projects/activities/changes on schedule

  • Holistically reviews and approves laboratory data, and have an extensive overall knowledge of laboratory operations

  • Designs, executes, reviews, and approves compliant test method transfer and validation protocols and reports and equipment qualification/computer validation records; assist with protocol non-conformance evaluations

  • Identities and seek out external resources (e.g. PDA, ISPE) to build or enhance understanding of scientific discipline; actively supports training of staff; understands the importance of and mentors and coaches junior colleagues

  • Demonstrates strong investigative or technological orientation with independence for design of projects/studies and makes significant independent contributions to the development/improvement/trouble shooting of methodology including new technologies and automation

  • Independently handles complex investigations and determine associated CAPA with minimal guidance

  • Details requirements for LIMS builds and/or building and testing new LIMS builds and LIMS Master Data changes

  • Knowledge of US, EU, and ROW cGMP; pharmacopeias; ICH guidelines; and microbiology techniques and instrumentation, Laboratory Information Management System (LIMS); Global Quality Tracking System (TrackWiseTM application); Microsoft Office™ applications specifically Word, Excel, and PowerPoint; statistical software such as JMPTM and Minitab; Lean Six Sigma concepts; Lean Labs; project management tools including stakeholder management; formal Quality Change Control, Investigations, and Documentation systems, and Quality Risk Management including risk assessments.

  Qualifications

  Must-Have

  • High School Diploma (or equivalent) and ten years of relevant experience;

  • OR a relevant Associate's degree with eight years of relevant experience;

  • OR a relevant Bachelor’s degree with at least five years of relevant experience;

  • OR a relevant Master’s degree with at least three years of relevant experience;

  • OR a relevant Ph.D. with 0-2 years of relevant experience.

  • Experience in Pharmaceutical Quality Control/Quality Operations

  • Pharmaceutical microbiological testing experience and extensive Good Manufacturing Practice knowledge

  • Experience developing, optimizing, and troubleshooting microbiological assays.

  • Experience in auditing with Good Manufacturing Practices {also cGMP} regulated industries

  • Highly motivated, organized and able to work effectively in a demanding environment with flexibility to changing priorities

  • Continuous improvement and development / implementation of best practices in Quality Operations or manufacturing

  • Reasoning ability, including strong analytical and problem-solving abilities

  • Strong verbal and written communication skills

  • Strong planning & organizing skills

  Nice-to-Have

  • Knowledge of electronic systems including Laboratory Information Management System Application

  • QRM Facilitation Experience

  • Investigation Quality Approval

  • Cell banking experience

  PHYSICAL/MENTAL REQUIREMENTS

  • Ability to analyze complex data and evaluate microbiological results

  • Basic computer skills, such as data entry with a high level of attention to detail

  • Long periods of standing, walking, and/or sitting

  • Occasional lifting (less than 35 lbs.) and reaching

  • Extended time working at a computer

  • Potential requirement to pass near vision and colorblindness tests

  NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

  • Primarily first shift Monday - Friday.

  • Off-shift, weekend, and/or Holiday hours may be required to meet business and/or customer needs.

  • Possibility of cross-site support. Travel <>

  • This is an on-site position.

  Other Job Details:

  • Last day to Apply: Feb 9th, 2024

  • Eligible for Relocation Assistance: YES

  • Work Location Assignment: On premise

  The annual base salary for this position ranges from $109,400.00 to $182,300.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 15.0% 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.

  Quality Assurance and Control

  #LI-PFE

• About the company

  At Pfizer we know that great things happen anywhere people come together with one shared goal. And the greatest rewards are sometimes where you least expect them. The future of medicine is happening at Pfizer.

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