Perform cell-based procedures that support product development, characterization, and release testing. Activities may include thawing and handling of primary human cells and cell therapy products, cell culture and expansion, cell selection and enrichment, activation, transduction, transfection, sample preparation, flow cytometry-based characterization, and functional assays. Participate in or lead analytical method qualification and validation activities. Develop study protocols, establish appropriate assay performance criteria, execute studies, analyze results, and prepare qualification or validation reports. Depending on the intended use of the assay, studies may include evaluation of accuracy, precision, specificity, sensitivity, linearity, range, robustness, system suitability, limits of detection or quantitation, and appropriate controls and reference materials. Support implementation and lifecycle management of analytical procedures in a regulated environment. Review analytical data for completeness, accuracy, traceability, and compliance with approved procedures, specifications, and acceptance criteria. Participate actively in the IMCPL Quality Management System. Responsibilities will include support for deviations, laboratory investigations, out-of-specification and out-of-trend results, corrective and preventive actions, change control, risk assessments, document control, equipment-related investigations, and continuous improvement activities. Author, review, and revise controlled documentation including Standard Operating Procedures, analytical methods, test procedures, batch records, worksheets, specifications, qualification and validation protocols, validation reports, technical reports, investigation reports, and training materials. Documentation must be clear, scientifically accurate, reproducible, and appropriate for a regulated cell and gene therapy environment. Train laboratory personnel in analytical procedures. Participate in analyst competency and proficiency programs, support qualification of staff for independent assay execution, and help maintain consistent analytical performance across the laboratory. 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. The Senior QC Specialist may contribute technical and analytical information used in 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, laboratory readiness
Manages day-to-day laboratory operations while ensuring compliance with safety regulations and best practices. Works with, adapts, and installs scientific equipment in research laboratories. Develops and collaborates on routine projects and procedures. Manages inventory and equipment and performs budget functions.
The Senior QC Specialist will support the development, qualification, validation, execution, and lifecycle management of analytical procedures used for the characterization and release of cell and gene therapy products at the Immunologic Monitoring and Cellular Products Laboratory (IMCPL). The position requires a strong foundation in molecular biology and hands-on experience with analytical and cell-based methods used to assess product safety, identity, purity, impurities, potency, biological activity, and other relevant quality attributes. This is a hands-on laboratory role that combines routine and non-routine QC testing with analytical development, troubleshooting, documentation, investigation, training, and quality-system responsibilities. The successful candidate will work closely with Quality Control, Quality Assurance, Manufacturing, and product development teams and will be expected to understand the relationship between assay performance, manufacturing processes, product quality, and clinical release. Develop, optimize, qualify, validate, execute, and maintain analytical procedures supporting cell and gene therapy products. Assays may include molecular, cellular, biochemical, and functional methods used to evaluate safety, identity, purity, process- and product-related impurities, potency, biological activity, gene or transgene expression, vector- or genome-related attributes, residual materials, stability, and product comparability.
Perform molecular biology assays including PCR, qPCR, DNA- and RNA-based analyses, gene-expression assays, and related analytical procedures. Troubleshoot assay performance, investigate atypical results, identify sources of analytical variability, and implement appropriate corrective strategies.
Sitting and standing for long periods at the bench. Reading small print on tubes, vials and other things. Walking around campus and between labs and walking to attend meetings when necessary. Bending and lifting up to 30 pounds. Bending and lifting to put away lab supplies. Working under standard laboratory and office lighting.
The University of Pittsburgh is an equal opportunity employer / disability / veteran.
Job Details
- Assignment Category: Full-time regular
- Job Classification: Staff.Laboratory Manager II
- Job Family: Research
- Job Sub-Family: Laboratory
- Campus: Pittsburgh
- Minimum Education Level Required: Bachelor's Degree
- Minimum Years of Experience Required: 3
- Substitution in lieu of education or experience: Combination of education and relevant experience will be considered in lieu of education and/ or experience requirement.
- Additional details about Required Licensure/Certification: NA
- Work Schedule: Monday - Friday, 8:30 a.m. - 5:00 p.m., schedule as set with supervisor
- Work Arrangement: On-Campus: Teams that work on campus, in an office, or in a lab.
- Hiring Range: TBD Based Upon Qualifications
- Relocation Offered: No
- Visa Sponsorship Provided: No
- Background Check: For position finalists, employment with the University will require successful completion of a background check
- Child Protection Clearances: Not Applicable
- Required Documents: Resume, Cover Letter
- Optional Documents: Not Applicable