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
Skills Required
- Bachelor's degree in Engineering, Life Sciences, Biotechnology, Project Management, or a related field
- 5–10 years of experience in pharmaceutical, biotechnology, cell therapy, or regulated manufacturing
- Experience independently leading complex investigations and CAPA execution
- Strong understanding of cGMP, FDA/EMA regulations, and quality systems
- Experience with electronic Quality Management Systems
- Exceptional analytical, problem-solving, and technical writing skills
- Ability to work autonomously in a fast-paced manufacturing environment
- Ability to influence cross-functional teams and drive timely record closure
- Experience in cell therapy, biologics, aseptic processing, or advanced therapy manufacturing
- Proficiency with MES, LIMS, TrackWise, or similar systems
- Formal training in root cause analysis methodologies such as Kepner-Tregoe, Ishikawa, or 5-Why
- Experience mentoring or training junior investigators
What We Do
BioPharma Consulting JAD Group provides a complete portfolio of technical support and solutions for the FDA regulated industry. We deliver solutions with a flexible cost effective approach to meet your company’s needs. BPC JAD group is a company created to help our customers bridge the gap between their business strategy and results. Our mission is to help our clients succeed by partnering with them and providing value added business solutions on the validation, engineering and compliance fields. We will carry out our mission by creating a long-term partnership with our customers and provide reliable and cost effective technical solutions. BPC JAD Group objective is to deliver reliable tailored solutions; from providing consultation to becoming part of your staff. We will develop customized frameworks to help our customers unlock the hidden value in their plants, facilities, equipment and people with an optimal integration of resources regulations and technology.
