QC Operations Leader - Site Startup & Tech Transfer

elevatebio; Pittsburgh (Allegheny County); On-site; USD 90,000 - 130,000; Full time

Job summary

ElevateBio is seeking an experienced Quality Control professional for our Pittsburgh facility to drive startup plans and establish QC operations. You will collaborate with MSAT and internal experts to implement procedural changes, digital systems, and business processes aligned to a defined project plan.

The role will help establish a microbiology function, support laboratory start-up, and eventually oversee QC docs, training, investigations, and outsourcing logistics in a GMP environment.

Qualifications

• 8+ years in GMP manufacturing with leadership experience.
• Experience with clean room qualification per ISO 14644.
• Experience with gene and cell therapy test methodologies (qPCR/ddPCR, Flow Cytometry, ELISA).

Responsibilities

• Own quality control procedure revisions to reflect desired business processes.
• Partner with MSAT on plans for initial tech transfer support and program onboarding.
• Assist in development, implementation, and maintenance of laboratory systems in compliance with applicable GMP practices and regulations.
• Support planning and implementation of site training program and implementation of EM and aseptic programs
• Review, trend and present data to senior management
• Oversee laboratory excursions, including; deviations, OOS, OOT and atypical investigations
• Participate in regulatory inspections and facility audits
• Hire, train and mentor staff

Skills

Team leadership

GMP knowledge

Quality systems

Regulatory inspections

Education

Bachelor's degree

Master's degree

PhD

Tools

LIMS

CMMS

QMS

ERP

Job description

ElevateBio is seeking an experienced Quality Control professional for our Pittsburgh facility to drive startup plans and establish QC operations. You will collaborate with MSAT and internal experts to implement procedural changes, digital systems, and business processes aligned to a defined project plan.

The role will help establish a microbiology function, support laboratory start-up, and eventually oversee QC docs, training, investigations, and outsourcing logistics in a GMP environment.