QC Senior Manager, Microbiology

Location
Redmond, WA
Posted
Apr 25, 2022
Ref
REQ-05103
Hotbed
BioForest
Required Education
Bachelors Degree
Position Type
Full time

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 with an emphasis in Microbiology to support the completion of the Facility and Water Qualification activities for our new manufacturing facility in Redmond, WA. The ideal candidate will have Commercial GMP experience, will possess exceptional leadership skills and will be a mentor to our science-based team. The successful candidate will have experience with LIMS implementation, as well as GMP laboratory experience. 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 for the new Commercial manufacturing facility. The ideal candidate has a keen attention to detail, is highly organized in their work and has strong written and verbal communication skills.

Responsibilities:

  • Lead and provide guidance for QC Microbiology testing and method qualification in support of GMP Biologics manufacturing, including in-process and drug substance release testing by Bioburden and Endotoxin techniques
  • Work with team members to support the GMP QC Laboratory operations and build the infrastructure for a Commercial QC Microbiology laboratory
  • Participate in hiring and lead a team of 5 individuals, mentor staff, and promote career development opportunities
  • Manage environmental monitoring activities
  • Assure timely reporting and management of Environmental Monitoring and Water Reports, Quality Control Methods, Standard Operating Procedures (SOPs), and Material Specifications
  • Participate in Quality Management Reviews
  • Work with LIMS team to develop QC templates and workflows to support the Redmond Facility and Utilities systems qualification and other QC laboratory requirements
  • Work with staff to operationalize Vitek MS for microbial ID
  • Introduce rapid bioburden methodology and validate for in-process use

Requirements:

  • BS in Microbiology, Biology, Biochemistry or related field and 8 – 12 years of experience and a minimum of 5+ years of hands-on, industry experience managing a cGMP QC Analytical or Microbiology laboratory
  • Expert understanding of ISO 14644 and USP/EU compendia methods
  • Audit experience
  • Experience working with electronic systems
  • Attention to detail and highly organized
  • Proficient at technical writing including analytical methods, technical summary reports and Standard Operating Procedures


Middle Management