Manufacturing Technical Operations

The Manufacturing Technical Operations (MTO) team, responsible for independently executing high‑complexity quality records that support cell therapy manufacturing at the Boston site. This role is investigation‑heavy, focusing on Deviations, CAPAs, Change Controls, and Analytical/Quality Control investigations within the electronic Quality Management System (eQMS). The Senior Specialist leads triage, SME coordination, root cause analysis, and drives timely, compliant closure of records in a fast‑paced, highly regulated environment.

Key Responsibilities

• Lead full‑complexity deviation investigations, including triage, data collection, GEMBA walks, and coordination with cross‑functional SMEs.
• Perform advanced root cause analysis using structured methodologies (5‑Why, Fishbone, GEMBA, KT).
• Independently own CAPA records from initiation through closure, ensuring robust effectiveness checks and alignment with compliance expectations.
• Initiate, assess, and execute Change Control records, ensuring accurate impact evaluations and cross‑functional alignment.
• Conduct and support Analytical and QC investigations, including data trending, method performance review, and identification of systemic issues.
• Ensure all quality records meet internal, regulatory, and industry standards for completeness, accuracy, and timeliness.
• Partner closely with Manufacturing, QC, QA, MS&T, Engineering, and Supply Chain to drive investigation closure and continuous improvement.
• Provide subject matter expertise during internal audits, external inspections, and regulatory interactions.
• Identify recurring issues and lead cross‑functional initiatives to strengthen process robustness and reduce deviation frequency.
• Serve as a mentor and technical resource for junior investigators and MTO staff.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, Biotechnology, Project Management, or related field.
• 5–10 years of experience in pharmaceutical, biotechnology, cell therapy, or regulated manufacturing environment.
• Demonstrated ability to independently lead complex investigations and CAPA execution.
• Strong understanding of cGMP, FDA/EMA regulations, and quality systems.
• Experience with electronic Quality Management Systems (eQMS) required.
• Exceptional analytical, problem‑solving, and technical writing skills.
• Ability to operate autonomously in a fast‑paced, dynamic manufacturing environment.
• Proven ability to influence cross‑functional teams and drive timely record closure.
• Preferred Skills
• Experience in cell therapy, biologics, aseptic processing, or advanced therapy manufacturing.
• Proficiency with MES, LIMS, TrackWise, or similar systems.
• Formal training in RCA methodologies (Kepner‑Tregoe, Ishikawa, 5‑Why).
• Experience mentoring or training junior investigators.