Partner Therapeutics · 19 hours ago
Supervisor, Quality Control-Analytical Testing
Greater Seattle Area
Full-time
Onsite
Senior Level
$92K/yr - $122K/yr
6+ years expPartner Therapeutics is a company focused on pharmaceutical manufacturing and quality control. The Supervisor, Quality Control-Analytical Testing will oversee the daily operations of the QC lab, ensuring compliance with regulations and supporting the testing needs of various departments while leading a diverse team to meet performance targets.
BiotechnologyHealth CareMedicalMedical DeviceTherapeutics
Responsibilities
Oversight of daily operations of QC PT/CB lab, supporting testing service needs for Manufacturing, Validation, Engineering & other Quality groups as needed
Supports safe, efficient, functional and compliant laboratories testing operations developed in accordance with site, corporate, and regulatory guidelines
Provides analytical expertise and support for product investigations, continuous improvements, etc. to ensure continued compliance with regulations
Develops and implements Quality Control laboratory systems that support metrics / data trending, management review, subcontractor qualification and audits for Leukine testing
Oversight of departmental training program
Oversight of departmental deviations/CAPA, change controls and laboratory investigations
Supports execution and continuous improvement for Drug Product, Bulk Drug Substance, In-Process and Raw Materials program(s)
Oversees sampling and laboratory testing execution ensuring timely results produced meet quality standards and requirements
Identifies and prioritizes implementation of opportunities to improve Quality processes and practices
Works collaboratively with inter-department and cross-functional teams to lead improvement implementations in a timely, effective and compliant manner
Reviews emerging and updated regulations and guidelines, stays current on industry trends and develop and implement gap remediation strategies with guidance from QC Manager, as necessary
Reviews and audits documentation to ensure accuracy, specifications and GMP Compliance
Participates in the development and prioritization of the Organization’s/Site’s Life Cycle Management Plan
Leads by example and promotes PTx’s core Values: Learn, Prepare, Innovate, Collaborate, Lead to continually improve the quality culture at PTx
Adheres to all applicable regulations and requirements including compliance with internal SOPs, GMP, Health and Safety, WISHA/OSHA, regulatory compliance, company policies, and employment-related laws and statutes
Successfully completes all mandatory Quality and Compliance training within required timeframes
Provides leadership and direction to the QC-Analytical Testing team and support teams to ensure KPIs are consistently met while demonstrating and embodying PTx leadership values
Establishes individual goals and objectives in alignment with department goals and priorities. Identifies performance improvement targets and metrics. Ensures capabilities and capacity are in place to effectively deliver on all departmental commitments and performance targets
Recommends and allocates resources - human, technical, etc. - to fulfill near term goals and commitments while building towards sustainable excellence
Builds, develops, inspires, motivates, and leads a diverse, professional team. Sustains high performance that is strongly aligned and coordinated with other functional groups across the organization; ensures Partner engagement by creating a culture of inclusion, execution, and an environment within which they can excel and continuously improve
Works pro-actively and in close collaboration with upline Leadership Team and People & Culture to recruit, hire, grow, and retain a diverse team of talent
Manages and develops the performance of direct reports by setting clear SMART goals, provides and seeks timely performance feedback, recognizes and rewards high achievers, and holds team members accountable for underperformance. Leads by example and promotes PTx’s core Values: Learn, Prepare, Innovate, Collaborate, Lead to continually improve the Quality Culture at PTx
Meets consistently with all Direct Reports in the GOOD 1:1 format and as a team to ensure 2-way updates, conversations, and alignment on goals and priorities are clear and reinforced regularly
Through active leadership and coaching, while embracing PTx’s Values and Behaviors, holds Team accountable for compliance to all safety and quality regulations, ensures all team members directly or indirectly support cGMP activities, and have the necessary education, knowledge, and skills to perform their job in accordance with applicable procedures and regulations
Pro-actively creates opportunities to develop their Team, including ensuring career paths have been developed for Partners (as needed), and enhances the Team through cross-training others, identifying competency gaps, etc
Qualification
Required
Effective scientific / technical knowledge with QC laboratory testing (e.g., wet chemistry assays, purity assays, and potency assays); Experience troubleshooting and investigating assay and equipment issues
Familiarity with USP and global compendial regulations
Skilled at managing projects with some oversight
Resourceful with proven ability to lead, manage and leverage an internal network of stakeholders and team members to plan and resolve issues. Strong relationship management and interpersonal skills required to quickly gain confidence of stakeholders and team members
Strong critical thinking, analytical, and problem-solving skills with the proven ability to formulate solutions to propel the organization forward
Possesses strong organizational and prioritization skills to maintain a high level of productivity and priority-setting in order to complete assignments on-time and on-budget. Demonstrated ability to delegate successfully
Excellent soft skills including a bias towards action, the ability and willingness to give and receive constructive feedback, is comfortable working within a diverse team and across multiple functions, exhibits a consistently constructive attitude, and is adaptable and at ease with handling unexpected changes and challenges
Proven ability to lead teams and/or projects effectively and to ensure GMP compliance while operating in an evolving, complex and dynamic environment
Experience implementing continuous improvement projects
Demonstrated commitment to fostering the professional growth and development of others; this could include training others on specific technical skills, mentoring, participating in workgroups that enhance development of others, etc
Knowledge of standard interviewing protocols; recent experience participating in the hiring process as an interviewer or hiring manager
Strong leadership skills included a demonstrated ability to drive accountability and build a departmental culture of trust, compliance, efficiency, and continuous improvement
Proven ability to enhance engagement by driving an environment within which individuals and teams can excel and continuously improve
Skilled at active listening, conflict resolution, and team building
Interactive training in essential people skills
Highschool diploma or GED
6+ years progressively responsible, relevant experience in an FDA regulated environment required. BA/BS degree or equivalent in related field may substitute for 2 years of relevant professional experience
1+ years of experience in a People Leadership or “Lead” role. People Leadership qualification includes experience in recruiting, making hiring decisions, setting SMART Goals, growing high performers, and addressing performance concerns. “Lead” qualification includes time in a formal Lead role, and/or leading project teams, and/or collateral activity teams, and participating on interview panels over an equal period of time
Preferred
Practical understanding of principles of project management; formal project management training a plus
Recent experience with workforce planning
Software application experience with Smartsheet, MS Project, and SharePoint
Previous experience participating in internal and external audits and inspections, including providing subject matter expertise and direct responses to agency regulators
Formal interview training
Formal people leadership training including development of giving-and-receiving-feedback skills
Company
Partner Therapeutics
PTx is a biopharmaceutical company committed to the development and commercialization of therapies that improve the treatment of cancer.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$60M2018-02-01Series A· $60M
Leadership Team
Martha Katz
Associate Director, New Product Planning and Operations Management at Partner Therapeutics
Sanjeev Ahuja, MD, MBA, FACP
Chief Development Officer: Neurology, Critical Care and Health Security
Recent News
MarketScreener
2025-10-23
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