QC Technical Operations Lead, Cell & Gene Therapy

ElevateBio; Waltham (IL); On-site; USD 120,000 - 160,000; Full time

Job summary

ElevateBio is seeking a Quality Control leader for our Pittsburgh facility to drive start-up and qualification efforts for clinical and commercial manufacturing. You will develop and implement GMP-compliant procedures, digital systems, and training programs while building the QC team and supporting tech transfer with MSAT.

The role requires extensive GMP manufacturing experience, strong leadership, and hands-on oversight of documents, investigations, and analytics in a cell/gene therapy

Qualifications

• Bachelor’s degree and at least 8 years of experience, OR Master’s degree with 6 years of experience, OR PhD with at least 4 years of experience.
• Experience supervising teams of people.
• Experience with clean room qualification per ISO 14644.
• Experience with compendial safety testing and rapid methodologies (BacT).
• Experience with gene and cell therapy test methodologies (qPCR/ddPCR, Flow Cytometry, ELISA, cell-based assays).
• Experience working with electronic systems (LIMS, CMMS, QMS, ERP).
• Ability to communicate and work independently with scientific/technical personnel.
• Strong knowledge of GMP, SOPs, and quality system processes.
• Excellent organizational skills.
• Experience in cell and gene therapy manufacturing environment a plus.
• Experience performing laboratory investigations.

Responsibilities

• Own quality control procedure revisions to reflect desired business processes. Support/review other functional documentation including protocols and reports.
• 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

Supervising teams

GMP/SOP knowledge

Communication

Organizational skills

Independent work

Lab investigations

Cell/gene therapy experience

Education

Bachelor’s degree

Master’s degree

PhD

Tools

LIMS

CMMS

QMS

ERP

Job description

ElevateBio is seeking a Quality Control leader for our Pittsburgh facility to drive start-up and qualification efforts for clinical and commercial manufacturing. You will develop and implement GMP-compliant procedures, digital systems, and training programs while building the QC team and supporting tech transfer with MSAT.

The role requires extensive GMP manufacturing experience, strong leadership, and hands-on oversight of documents, investigations, and analytics in a cell/gene therapy