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You've just received life changing news...cancer! The doctor recommends several rounds of chemotherapy. Unfortunately, chemotherapy not only targets the cancerous cells but the healthy tissues as well. During chemotherapy treatments, you experience fatigue, immunosuppression to other diseases, nausea/vomiting, hair loss, and other symptoms. What if there was a way to deliver that cytotoxic drug directly to the cancerous cells and not indiscriminately to healthy cells across the body, significantly reducing the adverse effects observed with chemotherapy? Pfizer is at the forefront of antibody-drug conjugates (ADCs) biotherapeutic development. ADCs attach a cytotoxic drug (monomethyl auristatin E or MMAE) directly to an antibody which is released upon uptake into the tumor-expressing cell killing it. This novel technology significantly minimizes the impact to healthy cells, thus reducing the toxic effects observed in chemotherapy and being a far more effective way to treat patients and increase survivability to life altering diagnosis.

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 position will support the Pfizer Sanford, NC Quality Operations department by performing Quality Control activities associated with clinical and/or commercial product, raw materials, and validation. Key responsibilities are performing GMP tasks associated with maintaining compliant Quality Control and Stability laboratories; testing, analyzing, interpreting, and trending results; and creating, reviewing and approving documentation.

Individual should have knowledge of current Good Manufacturing Practices (cGMP), Laboratory Information Management System (LIMS), Microsoft Office™ applications specifically Word and Excel, analytical techniques and instrumentation, Lean Six Sigma concepts, and Lean Labs.

In this role, you will:

• Acts safely and follows all EH&S safety requirements for site and QC laboratories.

• Be recognized as a "go-to" person or Subject Matter Expert for a specific subject area and are considered capable of supporting audits and investigations, reviewing/approving technical content to ensure scientific merit and compliance to regulations and Pfizer policy and standards.

• Excellent written and verbal communication skills

• Ability to identify issues, present complex problems with possible solutions, and actively take a leadership role to resolve issues.

• Ability to solve highly complex mathematical problems and situation-dependent problems using convoluted information.

• Ability to receive feedback from management and colleagues and take accountability for actions and personal development.

• Aptitude for good decision making based on procedures, guidance, and experience.

• Awareness to know their own limitations and seek senior scientist or management guidance when appropriate.

• Desire to ensure correctness and accuracy in tasks and documentation.

• Fitness of functioning as a team member and performing independent work with minor guidance

• Willingness to use personal skills and knowledge to achieve individual and company goals and objectives.

• Understanding of own area of function and knowledge of other cross functional areas

• Able to create, review, and approve test method and/or equipment validation records with limited guidance/coaching.

• Understands the importance of feedback and receives feedback well from management and other colleagues.

• Makes good decisions based on knowledge of quality systems and technical experience.

• Recognizes the impact of procedural changes that may impact future quality tasks and decisions.

• Able to review working instructions for technical content within own subject area and reference to applicable GMPs and regulatory expectations.

• Responsible for personal timelines and seeks advice if conflicts arise.

• Interacts with business lines and shares information with team; capable of influencing and negotiating with business lines.

• Ability to communicate effectively with good interpersonal skills.

• Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.

• Lead efforts to improve process performance, procedures and reporting to meet changing quality and regulatory compliance.

• Able to create, review, and approve compliant test methods and training materials.

• Perform tasks associated with maintaining Current Good Manufacturing Practices (part of GxP), compliant Quality Control, and Stability laboratories.

• Support preparation of reagents, receipt, storage and handling of reagents.

• Perform testing including but not limited to clinical and/or commercial product, raw materials, validation, stability, and Environment Monitoring samples.

• Support detailing requirements for Laboratory Information Management System builds, building, testing and managing its Master Data changes.

• Review and authorize all laboratory data and have an extensive overall knowledge of all laboratory operations.

• Serve on cross functional teams to represent Quality Control and facilitate communications and activities/projects.

• Perform various inspections of laboratories and surrounding office area as assigned and prepare a report.

• Participate in out-of-specification and failure investigations and recommend corrective actions and demonstrate problem solving abilities.

• Train junior colleagues and may develop training plans and/or oversee training activities for groups.

Here Is What You Need (Minimum Requirements)

• Applicant must have a Bachelors with at least 9 years of experience OR Masters with more than 4 years of experience or a PhD with 0+ years of experience.

• Demonstrated experience in manufacturing, quality or engineering experience in the biotech or pharmaceutical industry.

• Fundamental understanding/use of laboratory instrumentation function and analytical testing focused on analytical methods (e.g. HPLC/UPLC, iCIEF/Maurice, Purity/PA800+, plate-based methods)

• Experience with Laboratory Information Management System (LIMS) and Data review

• Aptitude for good decision making based on procedures, guidance, and experience.

• Effective communication skills

• Knowledge of Microsoft Office applications, specifically Word and Excel

• Excellent effective written and verbal communication and interpersonal skills

• Ability to work in a team environment.

Bonus Points If You Have (Preferred Requirements)

• Experience defending laboratory practices in regulatory audits and Quality Operations

• Relevant experience in biotherapeutics (antibodies, vaccines, and gene therapy)

PHYSICAL/MENTAL REQUIREMENTS

• Ability to lift 30 lbs, stand for 2 to 3 hours at a time, sit for 2 to 3 hours at a time, walk long distances and bend to obtain items from lower shelving/cabinets.

• Intellectual capability to perform complex mathematical problems and perform complex data analysis.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Work schedule is second shift (3:00 pm to 11:30 pm) but can include weekdays and/or weekend days as appropriate for assigned tasks/activities. Minimal flexibility in work schedule to cover business needs. Minimal off-shift work to ensure business needs are met.

• Non-existent to minimal travel.

• Must be able to wear appropriate PPE (e.g., lab coat, safety glasses, non-porous shoes, gloves, etc.)

• Work Location Assignment: On Premise

OTHER JOB DETAILS

• Last Date to Apply for Job: April 11, 2025

• Referral Bonus Eligibility: YES

• Eligible for Relocation Package: NO

The annual base salary for this position ranges from $96,300.00 to $160,500.00. 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.

Quality Assurance and Control

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