20.08.24

Microbiology Method Transfer Scientist

  • Permanent
  • USA
  • CDMO

WHO?

INCOG Biopharma Services are seeking a highly motivated Microbiology Method Transfer Scientist who 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.

There is a growing need globally for more CDMOs 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.

Having recently been voted as one of the Best Places To Work in Indiana for the third year in a row, INCOG is the perfect place to continue building your career.

Job Functions:

  • Test out, redefine and develop the INCOG QC Method Transfer program for both analytical and microbiological assays, in particular: endotoxin, bioburden, and sterility testing.
  • 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.
  • 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.
  • This role may require flexibility to work outside of core business hours. (ie. early mornings or later evenings depending on business needs.)

Candidate Requirements:

  • B.S./B.A. in Biology, Microbiology or Biochemistry.
  • 5+ years of microbiology and other related experience in GMP manufacturing/GMP QC testing of pharmaceuticals.
  • 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 method development and method transfer.

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

Reach out to Connor at connor@leadcandidate.com to find out more!

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.

Apply here
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