Quality Control Bioassay Manager

Just is seeking a highly motivated individual who desires a significant opportunity to improve worldwide access to biotherapeutics. We are looking for someone to join a fast paced, collaborative, and multidisciplinary team. This individual will join the Quality Control management team supporting the GMP manufacturing facilities in Redmond, WA and Seattle, WA. As the QC Bioassay Manager, you will be responsible for the daily oversight for the QC Bioassay lab operations in support of routine GMP operations, method transfer, validation and method lifecycle activities at Just-Evotec. The ideal candidate will have commercial GMP experience, will possess exceptional leadership skills and be a mentor to our science-based bioassay team.  Responsibilities will include in-process and drug substance sample testing, training of laboratory staff, GMP document authoring / revision, providing oversight in support of GMP operations and spearheading initiatives to build infrastructure and processes across both Washington state facilities. The ideal candidate will have significant experience in cell-based methods with strong data analysis skills. Experience with immunoassay and qPCR method execution is required.

Responsibilities:

• Provide hands-on leadership for the QC Bioassay lab operations; management of daily/weekly/monthly activities of staff and operational oversight of group, data review, schedule, and training.
• Oversee multiple QC analysts and direct management of individuals, including goal setting, performance feedback, skills development, and mentoring.
• Lead and provide guidance for QC Bioassay testing and method qualification in support of GMP Biologics manufacturing, including in-process, stability, drug substance and drug product release testing by techniques such as cell-based assays, ELISA, and qPCR.
• Collaborate with Analytical Development to generate and approve protocols, reports, and other technical documents required for the qualification and transfer of bioassay methods.
• Collaborate with Quality Assurance, Manufacturing, Material Management, and other functions to ensure internal timelines, testing TAT and team milestones are achieved. 
• Oversee laboratory investigations, deviations, OOS, and CAPAs
• Create, maintain, and revise QC Bioassay SOPs, methods and associated documents.
• Manage all aspects of the Bioassay labs including the ordering supplies and maintaining laboratory equipment and lab spaces.
• Support client audit/inspection readiness plans and interact with regulatory agencies during inspections on Bioassay related matters.
• Establish and publish Key Performance Indicators (KPI) to track cGMP compliance for QC Bioassay. Capture metric information for use in continuous improvement of areas of responsibility.
• Participate in daily and weekly operation meetings and Quality Management Reviews.

Requirements:

• BS in Biochemistry, molecular / cellular biology or chemistry with a minimum of 10+ years of relevant experience within the pharmaceutical industry and a minimum of 8+ years of hands-on, industry experience managing a cGMP QC laboratory.
• Experience in the validation and transfer of release potency and impurity methods (cell-based assays, immunoassays, and qPCR).
• Direct leadership experience required.
• Extensive knowledge of regulatory requirements and guidelines (ICH, CFR, FDA) as they relate to drug substance and drug product release / stability testing.

Physical Requirements:

• Travel between Seattle and Redmond sites required.

This job description is intended to describe the general content of the job, and to identify the essential functions of and requirements for the performance of this job.  It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Because job requirements evolve with the changing needs of Just-Evotec Biologics business, this description is subject to change and may be modified at any time, whether formally or informally.

The base pay range for this position at commencement of employment is expected to be $91,560 to $130,800;  Base salary offered may vary depending on individual’s skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits.

Evotec (US) Inc. is an Equal Opportunity Employer.  All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.