Senior QC Specialist - Laboratory Manager II

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

Job summary

The University of Pittsburgh School of Dental Medicine is seeking a Senior QC Specialist - Laboratory Manager II to lead analytical method development and validation for cell and gene therapy products. The role emphasizes hands-on molecular biology work, documentation, and cross-functional collaboration in a regulated environment.

The successful candidate will manage day-to-day QC activities, train staff in analytical procedures, and contribute to CAPA, deviations, and regulatory readiness.

Qualifications

• Bachelor's degree required with at least 3 years of QC/analytical experience in cell or gene therapy or related field.
• Experience with analytical method qualification/validation and documentation in a regulated environment is expected.
• Strong writing and documentation skills for SOPs, reports, and regulatory submissions are required.

Responsibilities

• Develop, qualify, validate, and maintain analytical procedures for cell and gene therapy products.
• Perform molecular biology assays (PCR/qPCR) and other analytical workflows and troubleshoot issues.
• Review data for accuracy, traceability, and compliance with procedures and specs.
• Support deviations, CAPAs, change controls, and risk assessments within the QA/QC framework.
• Collaborate with Manufacturing, QA, and product development teams for lifecycle management.

Skills

Molecular biology

Quality control

Analytical methods

Cell culture

Education

Bachelor's degree

Tools

PCR

qPCR

Flow cytometry

Job description

Job Description - Senior QC Specialist - Laboratory Manager II

Job Description - Senior QC Specialist - Laboratory Manager II (26006109)

Senior QC Specialist - Laboratory Manager II

Health Sciences Core Research Facilities - Pennsylvania-Pittsburgh - (26006109)

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

Job Summary

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.

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.

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

The University of Pittsburgh is an equal opportunity employer / disability / veteran.