Associate QC Chemist, 3rd Shift

About the role

The QC Chemist plays a pivotal role in supporting development, readiness, and routine testing activities for the Quality Control Chemistry laboratory. They are responsible for generating ALCOA+ data and upholding the Quality Mindset through attention to detail, on-time delivery, and commitment to Quality excellence.

Responsibilities

• Perform routine and batch-related testing on incoming components, raw materials, in-process samples, finished product, and stability samples according to validated methods as well as special testing deemed necessary by protocols
• Create/revise SOPs and other relevant documents related to laboratory equipment and/or processes
• Assist in the completion of laboratory investigations/deviations and provide SME support where needed
• Execute routine laboratory work orders for maintenance and non-critical calibrations
• Perform basic troubleshooting activities with respect to methods/assays, equipment malfunctions, and investigations (Deviations and OOS)
• Support internal and external customers to ensure proper and timely execution of all aspects of the clinical/commercial analytical method life cycle across clients
• Conduct periodic reviews of analytical test procedures and SOPs as required
• Aid in the professional support and development of QC Chemistry Technician staff within the QC laboratory
• Set deadlines and prioritize work for self, group members, and support groups involved
• Review/approve work performed by coworkers for accuracy and alignment with procedures
• Collaborate with internal departments and teams to resolve quality issues regarding facility, products manufactured, and released
• Identify, evaluate, and implement continuous business process improvements

Requirements

• Bachelor's Degree in Science (Chemistry or Biochemistry)
• Minimum of 3+ years of biopharma industry experience, with at least 2 years of hands-on experience in 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
• Exceptional computer skills evidenced by hands-on work with automated data management and/or data analysis systems (LIMS, JMP, Minitab, etc.)

Qualifications

• Excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences
• 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)

Skills

• Strong attention to detail
• Ability to work independently and as part of a team
• Excellent interpersonal skills
• Proficiency in laboratory equipment and assays

Benefits

At INCOG BioPharma, we offer a competitive benefits package that includes:

• Health insurance
• Retirement savings plan
• Flexible work schedule
• Professional development opportunities

Pay

Competitive salary commensurate with experience

Schedule

This position supports primarily third shift (11 pm to 7:30 am)