What are the responsibilities and job description for the Quality Control Microbiology Manager position at INCOG BioPharma Services?
QC Microbiology Manager
INCOG Biopharma Services in Indianapolis, IN is hiring an Quality Control Microbiology Manager. They are seeking a QC Microbiology Manager that has a passion for leading people, and has familiarity with transformational, situational, and servant leadership concepts. The Manager will support continuous personal and professional development of QC microbiology staff through meaningful goal setting, performance management, and career development plans.
The QC Microbiology Manager will work closely with the Director of QC and will develop and maintain the program for performing microbiological in-process, release, and stability testing of parenteral injectable products and the requisite supporting testing (e.g. environmental monitoring, cleaning validation, incoming QC). The Manager will be influential in championing and developing INCOG’s Quality Mindset through ingrained quality with skills including attention to detail, on time delivery, and efficiency into the Quality Control organization you will continue to build.
There is a growing need globally for more CDMOs (contract development and manufacturing organization) in the pharmaceutical industry to provide comprehensive services from drug development through drug manufacturing.
At INCOG, they are more than just a CDMO. A better way to create more meaningful experiences. A better way to create a culture that everyone can thrive and succeed in. At their core, that is who they are—a dedicated team that believes they can always be better.
Join the team at INCOG, a world-class CDMO for parenteral injectable drugs, shaping a new future for patients, for yourself, and INCOG’s clients.
Job Functions:
- Lead, build, and foster a diverse team to establish and maintain the GMP QC Microbiology laboratory.
- Train, support, and maintain an engaged workforce competent in microbiological testing required to support a state-of-the-art aseptic drug product manufacturing facility.
- Lead through coaching, mentoring, and maintaining at-the-bench presence in the laboratory to ensure rigorous scientific and quality work standards.
- Lead development of a world-class QC platform by leveraging expertise to establish a robust environmental monitoring program and develop laboratory processes that adhere to procedures and regulatory requirements for the evaluation of microbiological aspects of drug products, excipients, and process materials. This minimally includes tests for sterility, endotoxin, and bioburden.
- Advocate for clients by collaborating cross-functionally to schedule microbiological sampling, testing, instruments, and personnel to meet customer needs and timelines. As the SME, maintain a state of constant inspection-readiness in the QC laboratories, and act as a key point-of-contact for regulatory agencies during inspections and audits.
- Lead laboratory investigations using troubleshooting tools to identify errors, and exercise rapid decision making to implement corrective actions during OOS/OOT and other non-conformance events.
Candidate Requirements:
- B.S. in Biochemistry, Biology, or Microbiology
- At least 5 years of biopharma industry experience, of which at least 2 years have been in a role tied to microbiology testing for aseptic drug products.
- Experience with practical implementation of FDA, EMA, and other regulatory authority expectations for Quality Control. First-hand experience participating in and/or hosting audits/inspections related to Quality Control
- Demonstrated experience with microbiology suitability development work and USP/EP microbiology requirements.
Additional Preferences:
- Advanced Degree
- Experience with Kaizen, Six Sigma, and/or Lean principles
- Experience in an isolator-based aseptic drug product manufacturing facility
- 2 years of experience as a people leader or supervisor
Why INCOG?
- Paid time off, based on tenure
- 11 paid holidays
- 401(k) plan with company match up, vested immediately
- Choice of health & wellness plans
- FSA and HSA options
- Onsite wellness facility
- Employee engagement activities; food trucks, monthly luncheons, fundraising events, team building competitions, offsite celebrations
