Microbiology Method Transfer Scientist

Microbiology Method Transfer Scientist

INCOG Biopharma Services in Indianapolis, IN is hiring a Microbiology Method Transfer Scientist. We are seeking a highly motivated Microbiology Method Transfer Scientist who will work closely with Quality Control 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 Microbiology 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.

This role will be a key member of the INCOG Quality Control laboratory team who has a passion for learning, collaborating, and contributing to the success of our clients. The Microbiology Method Transfer Scientist will be dedicated to the success of the Quality Control team, resulting in the production of the highest quality products for our clients.

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, we are more than just a contract development and manufacturing organization. A better way to create more meaningful experiences. A better way to create a culture that everyone can thrive and succeed in. At our core, that is who we are—a dedicated team that believes we can always be better.

Join us at INCOG, a world-class CDMO for parenteral injectable drugs, shaping a new future for patients for yourself, our clients, and patients.

Job Functions:

• Test out, redefine and develop new (where necessary) 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.
• 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.
• Maintain a constant state of safety and inspection-readiness in the QC laboratories. Use knowledge of quality principles, cGLPs, cGMPs, and regulatory standards to act as a key point-of-contact for regulatory agencies during inspections and audits.
• 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.
• Utilize various paper and automated systems to manage local QC and site policies, procedures, and technical reports throughout document lifecycles including authoring, reviewing, approving, and retiring.

Candidate Requirements:

• Be available to participate in lab activities and client meetings that may go outside of standard business hours (Monday-Friday 8 AM-5 PM).
• 5+ years of microbiology and other related experience in GMP manufacturing/GMP QC testing of pharmaceuticals & B.S./B.A. in Biology, Microbiology or Biochemistry.
• Experience with practical implementation of FDA, EMA, and other regulatory authority expectations for Quality Control, particularly related method development and method transfer.
• Experience with using laboratory instrumentation.
• Exceptional computer skills evidenced by hands-on work with automated data management and/or data analysis systems (LIMS, JMP, Minitab, etc.).
• Prior leadership experience in GMP QC laboratories supporting pharmaceuticals.

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

Don’t meet all the requirements? Don’t sweat! We’re always looking for an excuse to discuss your next opportunity. You might just surprise yourself…

Lead Candidate wholeheartedly supports Equality and Diversity in employment and opposes all forms of unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.