Overview
Quality Control Chemistry Manager Jobs in Fishers, Indiana, USA at INCOG BioPharma Services
QC Chemistry Manager
INCOG Biopharma Services in Indianapolis, IN is hiring a 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.
Job Functions:
Lead, build, and foster a diverse team to establish and maintain the GMP QC Chemistry laboratory.
Train, support, and maintain an engaged workforce 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, 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
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Title: Quality Control Chemistry Manager
Company: INCOG BioPharma Services
Location: Fishers, Indiana, USA
Category: Quality Assurance – QA/QC (Quality Control / Manager, QA Specialist / Manager, Quality Technician/ Inspector)
