Lead Candidate has the privilege of partnering with organisations who are growing something special, making a difference to society through improved patient therapies and care. One such partner, INCOG BioPharma Services are now looking to appoint a QC Microbiology Manager.
Their culture and priorities are different by design: focused on building long-term value for customers, committed to a service-culture mindset, technical excellence, and a collaborative and team-centred approach to doing business.
As they build a world-class CDMO for parenteral injectable drugs, they are in the process of constructing the GMP facility and organization from the ground-up, which provides the opportunity to leverage knowledge gained over multiple careers to "do it right" in all respects.WHAT?
This is where you come in! If you crave the challenge of creating systems from a blank sheet of paper and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you.
The QC Microbiology Manager will play a key role in developing 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).
Working closely with the Director of Quality Control, the role will include the following responsibilities:
- Recruit, build, and lead a team to establish a new 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.
As an experienced pharma professional and subject matter expert on all things Microbiology, you would be expected to possess:
- B.S. in Biochemistry, Biology, or Microbiology
- Minimum of 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.
This is an opportunity to be involved in building a new world-class CDMO for parenteral injectable drugs and shaping a new future for patients for yourself, clients, and patients. INCOG strive to be different, putting the team at the forefront of everything they do and every decision they make.
Based on-site in Fishers, Indiana, this role can't be offered fully remote but is flexible with a hybrid on site/home based split.
Lead Candidate are proud to partner with INCOG on their journey. So if you want to be part of something special from an early stage, please contact one of our Talent Champions today!