Senior Quality Control Microbiology Manager

2 weeks ago

Redmond, United States Just - Evotec Biologics Full time

Senior Quality Control Microbiology 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 Microbiology Manger, you will be responsible for the daily oversight for the QC Microbiology 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 microbiology 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 has a keen attention to detail, is highly organized in their work and strong written and verbal communication skills.

Responsibilities: Provide hands-on leadership for the QC Microbiology 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 Microbiology 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 bioburden, endotoxin testing, growth promotion, Gram staining, biological indicators, TOC, conductivity, microbial identification and plate reading. Provide microbial SME support for microbial investigations and microbiological/aseptic related challenges. Collaborate with Contamination Control Team by providing Environmental and Utility monitoring data and supporting investigations, trend analysis and report generation. Manage all aspects of the Microbiology 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 Microbiology/Environmental Monitoring related matters. Establish and publish Key Performance Indicators (KPI) to track cGMP compliance for QC Microbiology. 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 Microbiology, Biology, Biochemistry or related field and a minimum of 15+ years of relevant experience within the pharmaceutical industry and a minimum of 8+ years of hands-on, industry experience managing a cGMP QC laboratory. Direct leadership experience required. Expert understanding of cGMP's, FDA, USP, NSF regulations and ISO 14644 and USP/EU compendia methods Audit and/or regulatory inspection experience Experience deploying and working with electronic systems preferred. Attention to detail and highly organized. Proficient at technical writing including microbiological methods, technical summary reports and Standard Operating Procedures

Physical Requirements: Travel between Seattle and Redmond site required. Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet, and body.

The base pay range for this position at commencement of employment is expected to be $120,000 to $145,000; 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. #J-18808-Ljbffr

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