MANAGER/SENIOR MANAGER, QUALITY CONTROL OPERATIONS (DOE) (Hybrid/Onsite)

Partner Therapeutics is the 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.

POSITION OVERVIEW

The Quality Control (QC) Operations group oversees and is responsible for operational support of the lab-based testing related to the manufacturing and release of Leukine. This role will have significant experience in QC and be able to provide QC operational guidance related to QC lab activities which align with cGMP and other compliance requirements. These activities include owning the Sample Management, Release/CoA, LIMS, Stability, APR/trending, Equipment/Software commissioning, and other QC operational programs for the entire QC department at a product dedicated BDS/API manufacturing site in Lynnwood, WA.

KEY RESPONSIBILITIES

This is a key QC leadership position that is responsible for the QC Operations group that provides leadership to support the lab-based QC testing groups that produce cGMP testing results.

• Manage the day-to-day tasks of the QC Operations group responsible for performing sample management, release/CoA testing, stability, trend analysis, equipment/software commissioning and other operational functions for the QC department.
• The ideal candidate will have GMP/GxP laboratory experience, experience with computer system validation or equipment qualification and strong project management/leadership skills.
• Develop direct reports by setting clear “SMART” goals, providing timely performance feedback
• Align department and individual goals with site/functional goals and priorities. Ensure that the capabilities and capacity are in place to meet all departmental commitments and performance targets.
• Drive implementation and own the new LIMS/ELN system (Waters Nugenesis) which is expected to go-live Q2 2023 to ensure testing results are reported appropriately and efficiently.
• Author, review and approve procedures, risk assessments, protocols, reports, and other deliverable supporting a GMP operations.
• Ensure completion of change controls, investigations, and CAPA records within agreed timelines.
• Provide QC subject matter expertise to support audits/inspections, investigations and departmental initiatives.
• Ensure that the QC Operations group maintains compliance with health authority regulations and requirements.
• Effectively lead QC teams and support interacting with other groups such as Quality/QA, Manufacturing, Validation, Engineering, Materials, Finance and HR.
• Represent the functional QC area in meetings and compliance activities and other duties

QUALIFICATIONS

• 10+ years relevant cGMP/QC experience
• Bachelor’s degree in science related field or related discipline
• 3+ years demonstrated supervisor/management experience. Preferred skills in coaching/leading remote/hybrid staff.
• Knowledge of the compendial and regulatory requirements for QC laboratories.
• Technical expertise in either equipment/software commissioning OR release/stability/LIMS AND a desire to learn/grow into other areas.
• Demonstrated ability to work productively with QA and other stakeholders.
• Experience supporting internal and external health authorities audits and inspections.
• Strong interpersonal and professional skills to interact and build relationships with other departments and staff.
• Excellent written and verbal communication skills
• Project management experience desired
• Proven accomplishments in implementing a large system/project (ex. LIMS) strongly preferred

PTx is committed to the principles of competitive and pay equity for all of our Partners. The current pay range for this position for a Senior manager is $140,000.00 to $180,000.00. Manager Level is $109,000 - $155,000. 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.
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.

Job Type: Full-time

Pay: $140,000.00 - $180,000.00 per year

Please Note :
cpscodex.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, cpscodex.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, Site.com is the ideal place to find your next job.