QC Chemistry Method Transfer Scientist

QC Chemistry Method Transfer Scientist

WHO?:

If you’re an experienced QC Chemist or Microbiologist looking to take your next steps, this Method Transfer role is a great opportunity!

This exciting chance to join the team is offered by INCOG Biopharmaceutical Services, who are continuing to build their state of the art sterile injectable CDMO. Having won the Best Places to Work in Indiana 4 years in a row, INCOG is the perfect place to continue building your career!

INCOG Biopharma Services in Indianapolis, IN is hiring a QC Chemistry Method Transfer Scientist who will be working closely with the Senior Director of Quality. They will be instrumental in championing and developing the organization's batch review excellence. This role offers the opportunity to work at INCOG’s state-of-art sterile injectable CDMO during an exciting time of growth, contributing towards a better path to market for life-saving drugs.

WHAT?:

This role involves close collaboration with QC leadership and will provide develop and lead the program for performing method transfer for analytical and/or microbiological assays from client laboratories into the INCOG QC Laboratories.

The role responsibilities are, but are not limited to:

• 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.
• 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.

YOU:

Ideally, candidates will have a Bachelor’s degree in Biology, Microbiology, Biochemistry, or Chemistry, along with 5 years of GMP manufacturing QC testing of pharmaceuticals.

• 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.
• Ability to author scientifically sound SOPs, Work Instructions, Transfer Protocols and Summary Reports
• Prior leadership experience in GMP QC laboratories supporting pharmaceuticals is preferred but not essential

Curious? Send us your resume at apply@leadcandidate.com or you can find more information on our website.

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.