Senior QC Chemist

INCOG BioPharma Services • Fishers, IN

9d • Onsite

About The Position

INCOG is looking for a Senior Quality Control (QC) Chemist that has a passion for working within a team, a desire to drive how a Quality processes in a regulated setting and to uphold the integrity of data generated for clients.

The Senior 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. The Senior QC Chemist will:
Perform routine and batch related testing on in-process, finished product and stability samples as well as 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 but not limited to:
Sample inventory disposition/disposal.
Consumables ordering/inventory.
Preparing instruments for testing.
Laboratory waste management.
The Senior QC Chemist will be crucial in generating ALCOA+ data and upholding our Quality Mindset with skills including 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 Associate QC Chemist will exemplify excellent interpersonal skills and be capable of developing productive, customer-centric working relationships with colleagues, clients, suppliers, and partners. The Senior QC Chemist will thrive in a team environment but can also work autonomously with strong self-management and organizational skills.

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).

Responsibilities

• Assist in the coordination of training and provide training, when necessary, for fellow QC and Development personnel on instruments and assays when cross-training is needed.
• Shepherd 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.
• Ability to set deadlines and prioritize work for self, group members, and support groups involved. Ability to 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 101-250 employees