Senior Manager, QC Technical Operations (Biotech)

Location: On-site in Pittsburgh, Pennsylvania, United States

Company

Technology-driven biotech company providing integrated technologies, end-to-end services, and manufacturing expertise for advanced therapies from design through commercialization.

What you will do

• Lead quality control procedure revisions and review related protocols, reports, and functional documentation.
• Partner with MSAT on technology transfer support and program onboarding.
• Develop and maintain laboratory systems, training programs, environmental monitoring, and aseptic programs in accordance with GMP requirements.
• Review, trend, and present quality data to senior management.
• Oversee deviations, out-of-specification, out-of-trend, atypical, and other laboratory investigations.
• Participate in regulatory inspections and facility audits while hiring, training, and mentoring QC staff.

Requirements

• Bachelor’s degree with at least 8 years of experience, Master’s degree with at least 6 years, or PhD with at least 4 years.
• Extensive experience in a GMP manufacturing facility and experience supervising teams.
• Experience with clean room qualification under ISO 14644 and compendial safety testing, including rapid methodologies such as BacT.
• Experience with gene and cell therapy testing, including qPCR, ddPCR, flow cytometry, ELISA, and cell-based assays.
• Experience with LIMS, CMMS, QMS, and ERP systems, plus strong knowledge of GMP, SOPs, quality systems, and laboratory investigations.
• Ability to work on site in Pittsburgh and work nights, weekends, and holidays as needed.

Culture & Benefits

• Collaborative work with internal subject matter experts, core teams, and external project partners.
• Opportunity to help establish a new QC and microbiology function for clinical and commercial manufacturing.
• Physical work includes standing, walking, bending, lifting 15–20 pounds, and working in PPE.
• Reasonable accommodations are available for qualified individuals with disabilities.