Senior QC Manager - Microbiology

This position is responsible for the daily oversight and leadership for the QC Microbiology lab operations in support of GMP operations, method transfer, validation and method lifecycle activities at Just-Evotec. This includes 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.

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 with 8 years relevant Quality experience and 10 years’ experience in industry, including a minimum of 3 years of hands-on, industry experience managing a cGMP QC Analytical or Microbiology laboratory.
• Expert understanding of cGMP's, FDA, USP, NSF regulations and ISO 14644 and USP/EU compendia methods
• Audit and/or regulatory inspection experience
• Attention to detail and highly organized.
• Proficient at technical writing including microbiological methods, technical summary reports and Standard Operating Procedures
• Travel between Seattle and Redmond sites required.
• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet, and body.
  
  

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 $111,360-$152,425; 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.