Senior QC Specialist - Laboratory Manager II

Responsibilities

• Manage day‑to‑day laboratory operations while ensuring compliance with safety regulations and best practices.
• Adapt, install, and maintain scientific equipment in research laboratories.
• Develop and collaborate on routine projects and procedures, including inventory and equipment management and budget functions.
• Perform cell‑based procedures supporting product development, characterization, and release testing, such as thawing and handling primary human cells and cell therapy products, cell culture and expansion, cell selection and enrichment, activation, transduction, transfection, sample preparation, flow‑cytometry characterization, and functional assays.
• Lead analytical method qualification and validation activities: develop study protocols, establish assay performance criteria, execute studies, analyze results, and prepare qualification or validation reports.
• Support implementation and lifecycle management of analytical procedures in a regulated environment, reviewing analytical data for completeness, accuracy, traceability, and compliance with approved specifications.
• Participate actively in the IMCPL Quality Management System, including support for deviations, laboratory investigations, out‑of‑specification and out‑of‑trend results, corrective and preventive actions, change control, risk assessments, document control, equipment investigations, and continuous‑improvement activities.
• Author, review, and revise controlled documentation such as Standard Operating Procedures, analytical methods, test procedures, batch records, worksheets, specifications, qualification and validation protocols, validation reports, technical reports, investigation reports, and training materials.
• Train laboratory personnel in analytical procedures and participate in analyst competency and proficiency programs.
• Collaborate with Manufacturing, Quality Assurance, investigators, and product development teams to support analytical strategy, product characterization, specification development, manufacturing changes, comparability assessments, and regulatory activities.
• Contribute technical and analytical information for CMC documentation and regulatory submissions.
• Support technology transfer of analytical methods into IMCPL and assist with implementation of new analytical platforms, instrumentation, and laboratory capabilities.
• Participate in inspections, audits, and laboratory readiness activities.
• Develop, optimize, qualify, validate, execute, and maintain analytical procedures for cell and gene therapy product characterization and release, including molecular, cellular, biochemical, and functional assays.
• Perform molecular biology assays such as PCR, qPCR, DNA/RNA analyses, gene‑expression assays, and related procedures.
• Troubleshoot assay performance, investigate atypical results, identify sources of variability, and implement corrective strategies.

Requirements

• Bachelor’s degree (required).
• Minimum of 3 years of relevant experience.
• Combination of education and relevant experience may be considered in lieu of the stated requirements.
• No specific licensure or certification required.

Physical Requirements

• Sitting and standing for long periods at the bench.
• Reading small print on tubes, vials, and other items.
• Walking around campus and between labs, and attending meetings as needed.
• Bending and lifting up to 30 pounds, including handling lab supplies.
• Working under standard laboratory and office lighting conditions.

Schedule

• Monday – Friday, 8:30 a.m. – 5:00 p.m. (schedule set with supervisor).
• On‑campus work arrangement (teams work in office or lab settings).