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.

Benefits

• 1- year contract with possible extension
• Administrative shift

  Overtime Availability