Quality Control Chemist

2 days ago

Fishers, United States INCOG BioPharma Services Full time

QC Chemist (2nd Shift)


INCOG Biopharma Services in Indianapolis, IN is hiring a Senior QC Chemist. They are seeking a highly motivated individual with a passion for working within a team, a desire to drive Quality processes in a regulated setting and to uphold the integrity of the data generated for clients.


The QC Chemist will work closely with the QC Chemistry Manager and the Quality Control Method Transfer Scientists as well as Project Management and Supply Chain to support development, readiness, and routine testing activities for the Quality Control Chemistry laboratory.


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, 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.


Join the team at INCOG, a world-class CDMO for parenteral injectable drugs, shaping a new future for patients, for yourself, and for INCOG’s clients.


Job Functions:


  • Perform routine chemistry testing on incoming components and raw materials, in-process samples, finished product samples, and stability samples according to validated methods as well as special testing deemed necessary by special testing or protocols.
  • Create/revise SOPs and other relevant documents related to laboratory equipment and/or processes.
  • Participate in the completion of laboratory investigations/deviations and provide SME support where needed.
  • Execute routine laboratory work orders for maintenance and non-critical calibrations.
  • Assist in the development and execution of protocols for method transfers, method validations, stability studies, cleaning validations and any other special testing required from the Quality Control Chemistry laboratory.
  • Assist in training fellow QC and Development personnel on instruments and assays when cross-training is needed.
  • This is a 2nd shift role: 2-11pm


Candidate Requirements:


  • Bachelor’s Degree in Science (Chemistry or Biochemistry).
  • At least 3 years of biopharma industry experience, with at least 2 years of hands-on experience with a GMP environment/Quality Control testing in a regulated environment or other related experience.
  • High proficiency level in operating UHPLC/HPLC, GC, SoloVPE, UV-VIS, TOC, particulate matter analyses, method validation/transfer, and relevant laboratory computer systems with associated data integrity requirements.
  • Experience performing container closure integrity testing (CCIT), and testing/ characterization of biologic (monoclonal antibody, enzyme) and small molecule (peptide, mRNA) products is preferred but is not essential.


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

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