Job Description

Chemistry Method Transfer Scientist

INCOG Biopharma Services in Indianapolis, IN is hiring Chemistry Method Transfer Scientist. This individual will be a key member of the INCOG QC laboratory team, and will have a passion for learning, collaborating, and contributing to the success of INCOG’s clients. The Method Transfer Scientist will be dedicated to the success of the QC team, resulting in the production of the highest quality products for clients.

The Method Transfer Scientist will work closely with QC leadership and will develop and lead the program for performing method transfer for analytical and/or microbiological assays from client laboratories into the INCOG QC Laboratories. The Method Transfer Scientist will be committed to operating with a Quality Mindset in every aspect of their role, including attention to detail, on time delivery, and efficiency.

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 for INCOG’s clients.

Job Functions:

• Lead the development and implementation of the INCOG QC Method Transfer program for both analytical and microbiological assays.
• Perform assessments of both incoming client methods and compendial test methods for raw materials, container/closures, API/BDS, in-process, and finished products for suitability with existing INCOG laboratory capabilities to identify if additional chemicals or instruments are required.
• Partner with customers to develop, review, approve, and execute method transfer into the chemistry and/or microbiology laboratory.
• Collaborate with the Quality Team on building laboratory safety program to ensure a safe and quality-minded environment for all personnel working in the laboratory.
• Advocate for clients by collaborating cross-functionally to schedule microbiological sampling, testing, instruments, and personnel to meet customer needs and timelines.
• Support 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.
• Be available to participate in client meetings that may go outside of standard business hours (Monday-Friday 8 AM-5 PM)

Candidate Requirements:

• 5+ years of microbiology, chemistry, or other related experience in GMP manufacturing/GMP QC testing of pharmaceuticals.
• B.S./B.A. in Biology, Microbiology, Biochemistry, or Chemistry
• Experience with using laboratory instrumentation from pH/conductivity meters, osmometers, and density meters to more complicated systems used for UHPLC/HPLC, GC, CE, and icIEF analysis.
• Be available to support routine QC testing for raw materials, API/BDS, container/closures, in-process, finished products, and environmental monitoring as needed, even on alternate shifts.
• Experience with practical implementation of FDA, EMA, and other regulatory authority expectations for Quality Control, particularly related to method development and method transfer.
• Prior leadership experience in GMP QC laboratories supporting pharmaceuticals is preferred but is not essential.

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

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