Overview
Quality Control Microbiology Manager Jobs in Fishers, Indiana, USA at INCOG BioPharma Services
INCOG Biopharma Services in Indianapolis, IN is hiring a 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.
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, 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
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Science, Manufacturing, and Management
Industries
Biotechnology Research, Pharmaceutical Manufacturing, and Medical Equipment Manufacturing
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Title: Quality Control Microbiology Manager
Company: INCOG BioPharma Services
Location: Fishers, Indiana, USA
Category: Quality Assurance – QA/QC, Healthcare (Medical Science, Data Scientist)
