Manager, QC Microbiology

A renowned biopharmaceutical organization is looking to hire a strong microbiology leader that'll be responsible for leading key activities within the microbiology team and provide oversight of the QC Microbiology team including managing the training of junior microbiology staff and the qualification and validation of new assays to name a few. If you're interested in utilizing your leadership skills and microbiology expertise to lead an exciting team, please apply in and read the below for more information:

• Responsible for planning and prioritizing resource allocation for the quality control microbiology laboratory to meet testing requirements for product release, raw materials, utilities, and in-process samples.
• Oversee the QC Microbiology testing area including bioburden and endotoxin, and other microbiology testing areas.
• Manage the transfer of assays from the development group, qualify and validate new assays, and implement assays for quality control purposes to support manufacturing and marketing of the products.
• Conduct laboratory investigations related to product testing and compile reports to support product filings with regulatory agencies.
• Review and release test results, ensuring full cGMP compliance in laboratory operations.
• Prepare documents (IND, BLA, and MAA) to support regulatory filings.
• Collaborate with other QC groups to ensure timelines are met for release, technical transfers, stability, and in-process testing.
• Conduct laboratory investigations related to product testing.
• Compile reports to support product filings with regulatory agencies.
• Review and release test results.
• Ensure compliance with laws, regulations, guidelines, procedures, and practices governing microbiological QC testing, including departmental and corporate standard operating procedures and safety procedures.
• Promote technical and professional growth of QC analysts, encouraging excellence and continuous improvement in their performance.
• Collaborate effectively within the Quality Control groups and other departments.

Key Qualifications

• Bachelor's Degree in Microbiology or related field of study; Master's Degree in Microbiology or related field of study is preferred
• Minimum of 7 years of Microbiology experience in the pharma/biotech industry
• Minimum five (5) years in a team leadership role or supervisor experience
• Previous experience managing Microbiology staff including providing training
• Must have experience working within a cGMP environment
• Proficient in the validation/qualification of microbiological techniques