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Quality Control Chemist Summary:

INCOG is seeking a Quality Control (QC) Chemist with a passion for working within a team, a desire to drive Quality processes in a regulated setting, and a commitment to upholding the integrity of data generated for clients.

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

This role is crucial in generating ALCOA+ data and upholding our Quality Mindset through attention to detail, on-time delivery, and commitment to Quality excellence. Strict adherence to Good Documentation Practices (GDP) is required as Good Manufacturing Practice (GMP) testing is performed.

Excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences is critical in this role. The QC Chemist will exemplify excellent interpersonal skills and be capable of developing productive, customer-centric working relationships with colleagues, clients, suppliers, and partners. The QC Chemist will thrive in a team environment but can also work autonomously with strong self-management and organizational skills.

Essential Job Functions:

• 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
• Assist in sampling and testing of incoming materials requiring QC testing as needed
• 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
• Perform basic troubleshooting activities with respect to methods/assays, equipment malfunctions, and investigations (Deviations and OOS)
• Execute routine laboratory work orders for maintenance and non-critical calibrations
• Perform minor preventative maintenance on QC laboratory instrumentation as needed using written SOPs or assist vendors with access to systems/materials when vendor performs maintenance
• Execute day-to-day tasks within the laboratory including sample inventory disposition/disposal, consumables ordering/inventory, preparing instruments for testing, and laboratory waste management
• Assist in the control and management of laboratory waste in cooperation with relevant EH&S standards
• 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
• 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
• Review and approve analytical testing procedures and protocols as needed
• Assist in training fellow QC and Development personnel on instruments and assays when cross-training is needed
• Assist in the professional support and development of QC Chemistry Technician staff within the QC laboratory
• Be team-oriented and willing to act as both a facilitator of special projects and a contributor to special projects when needed
• 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

Special Job Requirements:

• This position will support primarily third shift (11:00pm-7:30am)
• 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
• Excellent 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, JMP, Minitab, etc.)

Additional Preferences:

• 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)

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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