Expert Science & Technology - Quality Control, Information Technology

Role Summary

Expert Science & Technology to join our team and help deliver high-quality solutions that support the management of data, analytical equipment and computerized system specialist. Responsible to support, maintain, update and troubleshoot GMP analytical equipment related items for Cell and Gene Therapies, and assist with site projects within tight timelines following guidelines and compliance. Knowledge of GxP regulations is recommended. Located onsite in East Hanover, NJ.

Responsibilities

• Acts as the SME for GxP lab systems for all analytical instruments in the analytical labs in TRD CGT (e.g., Flow cytometer, ddPCR, UPL, NGS, Empower).
• Ensures GxP lab systems are in compliance with regulatory requirements (21 CFR Part 11, Annex 11).
• Manage and continuously improve GxP lab systems/processes and support data integrity initiatives related to GxP lab systems.
• Collaborate with Analytical Development, Operations, IT, Engineering, and Validation to support GxP lab system lifecycle management from concept to retirement.
• Author, review, and approve corrective actions to protocols, investigations, non-conformance, CAPAs, and other records related to GxP lab systems.
• Review and lead improvements to existing lab systems; develop SOPs and training related to GxP lab systems.
• Represent GxP lab systems in meetings; track follow-up items through to completion.
• Plan and lead large GxP system projects (e.g., LIMS implementation and lab instrument qualification).
• Other related duties as assigned; Monday‚ÄìFriday with potential weekend support.

Qualifications

• Required: Bachelor‚Äôs degree; preferred in Biology, Biochemistry, Molecular Biology, Immunology, or related field.
• Required: minimum 3 years of industry experience in automation/digitalization projects and Pharmaceuticals.
• Required: experience in instrument administration, preferably in CGT.
• Required: strong knowledge of regulatory requirements and industry standards (GxP, FDA 21 CFR Part 11, EU Annex 11).
• Required: experience with validation lifecycle documentation (URS, FRS, DS, IQ, OQ, PQ, and traceability matrices).
• Required: working knowledge in SQL, Java, or other LIMS programming language.
• Required: experience in lifecycle management of GxP lab systems.

Desired Qualifications

• LIMS administration a plus.
• Experience working with AAV, LVV and cell therapy analytics preferred.