SUPERVISOR, QUALITY CONTROL MICROBIOLOGY (Onsite)

SUPERVISOR, QUALITY CONTROL MICROBIOLOGY (Onsite)

Partner Therapeutics (PTx) is a commercial biopharmaceutical company committed to improving the lives of patients with cancer and other serious diseases. Our dedicated team brings a rigorous approach to science, establishes deep partnerships with medical and scientific communities, and works tirelessly to expand potential treatment options and address unmet medical needs for our patients.

POSITION DESCRIPTION

The PTx Microbiology group in Quality Control (QC) is responsible for environmental monitoring, testing, and reporting results that support the ability to maintain robust aseptic control over the biologics manufacturing facility located in Lynnwood, WA.  The ideal candidate will lead a dedicated team of Microbiologists in the prioritization, assignment, and peer review of daily work.  This person will also provide technical guidance and make decisions that pertain to their immediate area of expertise. This is a highly collaborative, cross-functional position that works closely with QA, Manufacturing, Validation, Facilities and Engineering departments.

PRIMARY RESPONSIBILITIES

Supervision

• Supervise direct reports by setting clear “SMART” goals and providing timely performance feedback.
• Provide oversight and leadership to the QC Microbiology team to ensure reliable and cGMP compliant operations.
• Perform/oversee product and facility testing, review/interpret data, and report results to internal customers such as QC Management, Manufacturing, and Validation.

• Lead change controls, investigations, and complete CAPAs in support of GMP operations.
• Support preparation of quarterly and annual reports, trend investigations, statements of quality, and other applicable reports.
• Establish personnel training plans and periodically assess suitability based on staff performance and capability.
• Facilitate onboarding and qualification of laboratory equipment and GMP software systems.
• Collaborate with site functional areas to support manufacturing and site goals, objectives, and timelines. Represent area of responsibility at meetings and in audits.
• Perform as a subject matter expert in inspections and audits, including activities such as readiness preparations, inspection responses and after-action reviews.
• Demonstrate flexibility in the daily prioritization of a fast-paced environment.
• Write/revise SOPs related to test methods and other processes, as well as technical documents including test methods, validation documents, and deviations.
• Author, review, own, collaborate, and complete records (Technical Reports, Protocols, Deviations, Excursions, CAPAs) in a timely manner.

• Robust technical knowledge of microbiology, critical utilities, pharmaceutical manufacturing environments, environmental monitoring, and QC microbiological testing.
• Strong analytical, problem solving, organizational, and time management skills required. Exhibit motivation and inspiration to build and retain a highly effective team. 
• Proven ability to recognize patterns/trends and experience proposing solutions to improve compliance or efficiency, or to support investigational root cause.
• Excellent verbal and written communication skills (English language) required.
• Ability to work collaboratively with inter-department and cross-functional teams to advance initiatives in a timely, effective, and compliant manner. 
• Capability to perform gowning for aseptic manufacturing areas.

Education and Experience

• S. in Microbiology preferred or directly relevant and equivalent degree 
• 5 years of experience in cGMP pharmaceutical manufacturing.
• The ideal candidate must have successful, practical experience of microbiology, critical utilities, pharmaceutical manufacturing environments, environmental monitoring, and QC microbiological testing.
• 2 years of supervisory experience
• Strong knowledge of cGMP regulations, ICH guidelines, and industry standards.  

To ensure we are able to consistently provide Leukine to patients around the world and in support of our friends, families, and neighbors, Partner Therapeutics requires all current and future employees to be fully vaccinated against COVID-19.  We require evidence of COVID-19 vaccination prior to hire, subject to reasonable accommodation and other requirements of applicable federal, state, and local law.    

In addition to medical, dental, vision, FSA/DCA, HRA, disability, and life insurance coverage, all full-time, regular Partners enjoy a casual, and Hybrid or Remote workplace program for many roles.  We offer a terrific compensation/benefits/perks package which includes pre-IPO options, annual cash bonuses, 401k matching, free parking or Seattle-area ORCA pass, tuition assistance, plus rewards for achievement and contribution. To support a healthy work-life balance we also provide a gym subsidy, wellness participation programs, and a generous vacation, sick, and holiday paid time off program in addition to a paid shutdown between the Christmas and New Year’s holidays.

Partner Therapeutics is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, sex, age, national origin, veteran status, marital status, sexual orientation, gender identity, disability or any other category prohibited by local, state or federal law. This policy applies to all aspects of employment, including recruitment, placement, promotion, transfer, demotion, compensation, benefits, social and recreational activities, and termination.