Senior Chemist

About the position

The Senior Quality Control (QC) Chemist at INCOG BioPharma is responsible for ensuring the integrity of data generated in a regulated laboratory setting. This role involves collaboration with various teams to support development and routine testing activities, while upholding quality standards and Good Documentation Practices (GDP). The Senior QC Chemist will perform testing on in-process and finished products, assist in method verification, and manage laboratory operations, all while fostering a culture of quality excellence.

Responsibilities

• Perform routine and batch related testing on in-process, finished product and stability samples.
• Support developmental study testing for MSAT.
• Assist Method Transfer group in generating low-complexity and/or compendial method verification protocols and summary reports.
• Assist in testing of incoming materials requiring QC testing.
• Create/revise SOPs and other relevant documents related to laboratory equipment and/or processes.
• Create Change Controls to bring in new laboratory instruments for GxP use.
• Participate in and drive laboratory investigations/deviations and provide SME support where needed.
• Execute routine laboratory work orders for maintenance and non-critical calibrations.
• Drive day-to-day tasks within the laboratory including sample inventory disposition/disposal, consumables ordering/inventory, preparing instruments for testing, and laboratory waste management.

Requirements

• Bachelor's Degree in Science (Chemistry or Biochemistry Preferred).
• Minimum of 4+ years of pharma/biopharma industry experience, with at least 3 years of hands-on experience with a GMP/GDP environment/Quality Control testing in a regulated environment.
• Proficiency in operating UHPLC/HPLC, GC, CE, ELISA, icIEF, SoloVPE, UV-VIS, TOC, particulate matter analyses, method validation/transfer, and relevant laboratory computer systems with associated data integrity requirements.
• Possesses a working knowledge, understanding and experience with practical implementation of FDA, EMA, and other regulatory authority expectations for Quality Control.
• Exceptional computer skills evidenced by hands-on work with automated data management and/or data analysis systems (LIMS, QMS, etc.).
• Experience in authoring/performing/driving laboratory investigations to GxP standards.

Nice-to-haves

• Ability to work in a regulated environment as indicated by a minimum of 2+ years of working in a GMP laboratory, clean room, or other regulated facility.
• Experience with Continuous improvement, Six Sigma, and/or Lean principles.
• Experience with building processes and procedures.
• Experience in performing testing and/or characterization of biologic (monoclonal antibody, enzyme) and small molecule (peptide, mRNA) products.
• Experience performing container closure integrity testing (CCIT).

Benefits

• Equal Opportunity Employer
• Commitment to a service-culture mindset
• Collaborative and team-centered approach