Senior QC Specialist - Laboratory Manager II

University of Pittsburgh; Pittsburgh (Allegheny County); On-site; USD 90,000 - 120,000; Full time

Job summary

The University of Pittsburgh's IMCPL Laboratory seeks a Senior QC Specialist to develop, qualify, validate, and maintain analytical procedures for cell and gene therapy products. This on-campus role requires a strong molecular biology background and hands-on assay work in a regulated environment.

The position involves PCR/qPCR and DNA/RNA analyses, troubleshooting and documentation, training of staff, and collaboration with QA, Manufacturing, and product development to ensure product safety,

Qualifications

• Strong foundation in molecular biology and hands-on experience with analytical and cell-based methods used to assess safety, identity, purity, impurities, potency, and biological activity.
• Experience with analytical development, troubleshooting, documentation, investigation, training, and quality-system responsibilities.
• Ability to develop, qualify, validate, and maintain analytical procedures for cell and gene therapy products.

Responsibilities

• Develop, optimize, qualify, validate, execute, and maintain analytical procedures for cell and gene therapy products.
• Perform molecular biology assays including PCR, qPCR, DNA- and RNA-based analyses and related procedures.
• Collaborate with Quality Control, Quality Assurance, Manufacturing, and product development teams to support regulatory activities and lifecycle management.

Skills

Molecular biology

Analytical methods

Cell-based assays

Troubleshooting

Documentation

Training

Quality systems

Education

Bachelor's Degree

Tools

PCR

qPCR

Job description

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.

Health Sciences Core Research Facilities

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

Essential 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.

Physical Effort

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.

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

Will this position accept 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.

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