QC Method Transfer Scientist, Chemistry

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 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.

The Method Transfer Scientist 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 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.

Essential 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.
• Holds self and others accountable for rigorous scientific and quality work standards.
• 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.
  
  

Special Job Requirements:

• Be available to participate in client meetings that may go outside of standard business hours (Monday-Friday 8 AM-5 PM)
• Use applied statistics to analyze and track test results to identify sources of variability and error in laboratory and manufacturing processes.  Use data trends to apply a systematic approach to resolve technical issues, prevent errors, identify improvement opportunities, and implement continuous improvement plans.
• Maintain regulatory intelligence on the regulatory landscape, policies, and pharmaceutical industry trends through continuous education, networking, literature, trade organizations, etc.
• 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.
• 5 years of microbiology, chemistry, or other related experience in GMP manufacturing/GMP QC testing of pharmaceuticals.
• Experience with practical implementation of FDA, EMA, and other regulatory authority expectations for Quality Control, particularly related to method development and method transfer.
• 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.
• Exceptional computer skills evidenced by hands-on work with automated data management and/or data analysis systems (LIMS, OpenLab CDS, ChemStation, etc.).
• Ability to author scientifically sound SOPs, Work Instructions, Transfer Protocols and Summary Reports.
• B.S./B.A. in Biology, Microbiology, Biochemistry, or Chemistry
  
  

Additional Preferences:

• Prior leadership experience in GMP QC laboratories supporting pharmaceuticals.
  
  

Additional info about INCOG BioPharma Services:

At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.

If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.

INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind.  All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.

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