QC Manager

Use Your Power for Purpose

Pfizers purpose is to deliver breakthroughs that change patients lives. To ensure patients receive safe potent efficacious and life altering cancer treatments the Bothell Quality Control Laboratory team performs release and stability testing on late phase/commercial antibody and antibody drug conjugate products. This role requires technical expertise in a cGMP laboratory with focus on plate-based methods (ELISA Cytotoxicity Bioassay and Impurity ELISA). The candidate must possess strong interpersonal skills such as communication and collaboration to lead troubleshoot and proactively solve problems and improve efficiency. Working in a fast-paced environment where learning and personal development are actively encouraged you will find the role both challenging and rewarding.

What You Will Achieve

• The selected candidate will serve as a Manager within the Quality Control Stability and Validation group which is currently part of the Analytical R&D organization and will be a part of the North Creek Manufacturing Plant beginning in January of 2026 (Pfizer Global Supply).

• This role involves supervising a team of 5-6 Quality Control Analysts performing plate-based method release and stability testing for late-stage and commercial monoclonal antibodies (mAb) and ADCs (antibody drug conjugates).

• This role oversees critical reagent qualification execution and will collaborate with critical reagent owners within BIS-BOT and PGS.

• The candidate must have experience with materials management sample management and shipping procedures as their group will serve as backup for sample management and perform occasional shipments of critical reagents to other Pfizer sites.

• Responsibilities include engaging with the North Creek Manufacturing Plant BIS-BOT other PGS sites External Supply Operational Quality (ESOQ) Contract Manufacturing Organizations and Regulatory Agencies.

• The candidate must possess comprehensive knowledge and experience in Cytotoxicity Assays Bioassays Binding ELISAs and Impurity ELISAs.

Role Responsibilities:

• Oversee 56 Direct Reports (Quality Control analysts) responsible for execution of plate-based methods for release and stability testing for late phase and commercial products.

• Approving time off and expense reports.

• Completing performance review of staff.

• Perform testing and review of plate-based method release and stability testing.

• Hold team accountable for meeting metrics for testing and review turnaround times.

• Serve as SME for all plate-based methods including ELISA Cytotoxicity Assays Bioassays and Impurity ELISAs for regulatory inspections and audits.

• Serve as SME for Out-Of-Specification Laboratory Investigation Procedure for cell-based methods.

• Serve as SME for Critical/Key Reagent qualification activities.

• Manage Critical/Key Reagent shipments and back-up activities for sample management activities.

• Author and serve in key roles for lab investigations deviations CAPAs and Change Controls.

Qualifications

Must Have

• A BA/BS degree in biology biochemistry immunology molecular biology analytical chemistry or a closely related discipline with 6 to 7 years of experience OR a Masters Degree with 3 to 6 years of experience OR PhD with less that 2 years of experience

• Experience managing personnel in a GMP environment through direct supervision along with collaborative and mentoring skills.

• Proficient knowledge of Laboratory Inventory Management Systems (LIMS) for testing critical reagent inventory and sample receipt/management.

• Experience in critical reagent qualification and lifecycle management activities including shipment of critical reagents.

• Experience in sample management activities including product shipment.

• Proficient knowledge of mAb/ADC plate-based methods including ELISA Cytotoxicity Assays Bioassays and Impurity ELISA.

• Strong written and verbal communication skills proficient time management innovation and adaptability to both independent and team environments within multidisciplinary and fast-paced settings.

• Demonstrated ability to deliver results under pressure and communicate effectively with project teams.

• Direct experience of interacting with regulatory authorities and leading laboratory tours during inspections and audits.

Nice to Have

• Trained in PHP Role for deviations.

• Strong leadership skills and the ability to influence cross-functional teams.

• Working knowledge of gLIMS.

Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers develop and coach others oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

PHYSICAL/MENTAL REQUIREMENTS

• Position requires occasional light lifting and periods of standing sitting or walking.

NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS

• Work Location Assignment: On premise work in a Pfizer site is needed for nature of job role. Position may have flexibility to work remotely from time to time but position is primarily on-site.

The annual base salary for this position ranges from $102900.00 to $171500.00. In addition this position is eligible for participation in Pfizers 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 lifes 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 (). 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.

Quality Assurance and Control