QUALITY CONTROL - MANAGER - MICROBIOLOGY (Hybrid/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.

DEPARTMENT DESCRIPTION:

Contamination Control group is focused on providing microbiologic expertise, investigative services, and contamination control leadership. They partner with cross function teams to ensure that the site maintains robust aseptic control over the manufacturing environment. Contamination Control will accomplish this by providing customer support and quality guidance for processing, environmental monitoring, cleaning and disinfection, access and flow, gowning, facilities, and utilities programs.

POSITION DESCRIPTION

In this position you will be expected to lead staff in the prioritization and assignment of daily work, provide technical guidance, and make judgment decisions as to the proper procedures to follow. This will be a cross functional position working closely with QC/QA/Manufacturing/Engineering in both ad-hoc and formal meetings. This role is expected to enhance the presence of contamination control on the production floor and help identify potential issues to ensure continued compliance and an audit readiness state. The primary focus will be to support and maintain a compliant culture that proactively strives for increased contamination control via risk-based assessment.

KEY RESPONSIBILITIES

Management (50%)

• Serve as a role model for fellow employees by acting responsibly, fairly, and honestly in all dealings and exercising sound judgement in performing job functions.
• Manage and develop performance of direct reports by setting clear “SMART” goals, providing timely performance feedback, and holding reports accountable for underperformance.
• Design and execute Department Training Plan(s)
• Provide oversight and leadership to the Contamination Control team to ensure KPIs are consistently met while demonstrating and embodying the PTx leadership values.
• Lead cooperative effort among members of a project team, including projects outside own area of expertise. Includes ability to influence and negotiate with others, as well as owning decisions around complex and/or specialized issues that impact inter-departmental processes.
• Perform inter-departmental presentations with effective expression of ideas, complex quality concepts, and solid rationale.
• Manage the coordination of the activities of the department with responsibility for producing results, including costs, methods, and staffing.

Microbiological Expertise (50%)

• Possess strong technical knowledge of microbiology, critical utilities, and environmental monitoring and testing.
• Provide scientific expertise and support for product investigations, site risk assessments, and continuous facility improvements, etc. to ensure continued compliance with regulations.
• Embrace new tasks and challenges with positivity. Demonstrate flexibility in a fast-paced environment to provide microbiologic and contamination control expertise.
• Perform as a primary participant in inspections conducted by internal and external agencies, including activities such as pre-inspection site audit readiness.
• Maintain ownership of department responsibilities such as site environmental excursion program, annual environmental risk assessments (EMPQ), and quarterly environmental and utility reports.
• Conduct risk assessments pertaining to contamination control (ie. recovered organism assessments).
• Author complex documents such as investigative protocols or technical reports (ie. DET studies).
• Develop content and present at monthly Contamination Control Board meetings.
• Ensure proposed processes improvements and/or CAPA align with current good manufacturing practices and industry practices/regulatory requirements.
• Initiate, design, and lead training courses on microbiological and contamination control topics.
• Own, collaborate, and revise associated Site Standard and SOPs.

REQUIREMENTS

• BS or MS in Microbiology or equivalent, or Strong microbiology background or Life Sciences technical background with a minimum 12 + years of progressively responsible experience in GMP pharmaceutical manufacturing and/or in biopharmaceuticals, biotechnology applications.
• 3 + years of demonstrated people leadership experience.
• Strong analytical, problem solving, and communication skills (verbal and written), and great time management skills. Exhibit motivation and inspiration to build and retain a highly effective team.
• Strong Knowledge of GMP Regulations: Respect the laws and operate within the applicable regulations of the places in which we conduct business, as well as adhering to internal Company policies and procedures.

PTx is committed to the principles of competitive and pay equity for all of our Partners. The current pay range for this position is $109,000.00 to $155,000.00: Offers are made within the base pay range applicable at the time. Your salary will vary depending on several factors including your qualifications and experience.

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.