What are the responsibilities and job description for the Quality Control Chemistry Manager position at INCOG BioPharma Services?
QC Chemistry Manager
INCOG Biopharma Services in Indianapolis, IN is hiring an Quality Control Chemistry Manager. They are seeking a QC Chemistry Manager that has a passion for leading people, and is familiar with transformational, situational, and servant leadership concepts. The Manager will support continuous personal and professional development of QC Chemistry staff through meaningful goal setting, performance management, and career development plans.
The QC Chemistry Manager will work closely with the Director of QC and will lead strategy and direction of the QC Chemistry group to partner cross-functionally to identify analytical needs, solve complex problems, and deliver solutions for various routine and non-routine processes. 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 help 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 Chemistry laboratory.
- Train, support, and maintain an engaged work force competent in both theory and application of analytical, separation, and physical sciences 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 chemistry platform by leveraging expertise to establish and launch instrumentation and laboratory workflows that adhere to procedures and regulatory requirements for the evaluation of chemical and physical properties of drug products, excipients, and process materials. This minimally includes tests for HPLC, GC, UV-VIS, TOC, particulate matter, FTIR, wet chemistry (e.g. pH, conductivity, osmometry, etc.), drug product lot release testing, stability testing, analytical method transfer, and analytical method validation.
- Prioritize and coordinate resources for QC Chemistry testing to balance client needs and production timelines with development work.
- Serve as a site subject matter expert on analytical and physical chemistry testing, laboratory instruments, laboratory and testing compliance, current Good Laboratory Practices (cGLPs), and current Good Manufacturing Practices (cGMPs). Maintain a state of constant inspection-readiness in the QC Chemistry 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 or Chemistry.
- At least 5 years of biopharma industry experience, of which at least 2 years have been in a role of hands-on experience with Quality Control testing in a regulated environment.
- First-hand experience participating in and/or hosting audits/inspections related to Quality Control.
Additional Preferences:
- Advanced Degree.
- Experience performing container closure integrity testing (CCIT).
- 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
