Microbiology Method Transfer Scientist

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.

WHAT?

• Test out, redefine and develop the INCOG QC Method Transfer program for both analytical and microbiological assays. Perform assessments of both incoming client and compendial test methods for raw materials, container/closures, API/BDS, in-process, and finished products for suitability with existing lab capabilities to identify if additional chemicals or instruments are required.
• Schedule microbiological sampling, testing, instruments, and personnel to meet customer needs and timelines.
• Support lab investigations using troubleshooting tools to identify errors, and exercise rapid decision making to implement CAPAs during OOS/OOT and other NC events. Utilize paper and automated systems to manage QC/Site policies, procedures, and reports throughout document lifecycles.

YOU!

The ideal candidate will have a BS/BA in Biology, Microbiology, or Biochemistry, as well as:

• 5+ years of microbiology/ other related experience in GMP manufacturing/ GMP QC testing of pharmaceuticals
• Experience with practical implementation of FDA, EMA, and other regulatory expectations for QC, particularly related to method development and transfer
• Leadership experience in GMP QC labs supporting pharmaceuticals
• Availability to participate in lab activities and client meetings that may go outside of standard business hours (M-F 8 am-5 pm)

WHY INCOG?

• Paid time off, based on tenure, as well as 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

Interested? Send us your resume at apply@leadcandidate.com or you can find the full job specification here: Microbiology Method Transfer Scientist – INCOG.

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.