# Manufacturing Technical Operations

**Company:** [BioPharma Consulting JAD Group](null/companies/pScfjBzGATtPx3geL93jwD.md)
**Location:** Boston, United States
**Workplace:** on site
**Employment type:** Contract

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## Description

The Manufacturing Technical Operations (MTO) team, responsible for driving the most complex, cross‑functional, and high‑visibility quality investigations supporting cell therapy manufacturing at the Boston site. This role is **heavily focused on investigations**, including Deviations, CAPAs, Change Controls, and Analytical/Quality Control investigations within the electronic Quality Management System (eQMS). The Expert Lead ensures rigorous triage, advanced root cause analysis, SME alignment, and timely, compliant closure of records in a fast‑paced, highly regulated environment.

**Key Responsibilities**

-   Lead **high‑complexity deviation investigations**, including triage, data mining, GEMBA walks, and coordination with multidisciplinary SMEs.
-   Drive advanced **root cause analysis** using structured methodologies (5‑Why, Ishikawa, KT, GEMBA) to identify systemic issues and prevent recurrence.
-   Own and execute **complex CAPAs**, ensuring robust effectiveness checks, cross‑functional alignment, and sustainable long‑term solutions.
-   Initiate and guide **Change Control** records, ensuring accurate impact assessments, risk evaluations, and implementation strategies.
-   Lead **Analytical and QC investigations**, including method performance review, data trending, and identification of quality risks.
-   Ensure all quality records meet internal, regulatory, and industry standards for completeness, accuracy, and timeliness.
-   Serve as a senior technical authority during internal audits, external inspections, and regulatory interactions.
-   Partner with Manufacturing, QC, QA, MS&T, Engineering, and Supply Chain to resolve complex issues and strengthen process robustness.
-   Identify patterns and recurring deviations, leading cross‑functional initiatives to reduce variability and improve manufacturing reliability.
-   Mentor junior and mid‑level investigators, providing coaching on investigation strategy, documentation quality, and compliance expectations.

## Requirements

-   Bachelor’s degree in **Engineering**, **Life Sciences**, **Biotechnology**, **Project Management**, or related field.

-   **10+ years** of experience in pharmaceutical, biotechnology, cell therapy, or regulated manufacturing environment.
-   Proven ability to independently lead **high‑complexity investigations** and CAPAs in a fast‑paced environment.
-   Deep understanding of **cGMP**, FDA/EMA regulations, and quality systems.
-   Extensive experience with electronic Quality Management Systems (eQMS).
-   Exceptional analytical, problem‑solving, and technical writing skills.
-   Strong leadership presence with the ability to influence and guide cross‑functional teams.
-   Demonstrated ability to manage multiple high‑visibility records simultaneously while meeting aggressive timelines.

**Preferred Skills**

-   Experience in cell therapy, biologics, aseptic processing, or advanced therapy manufacturing.
-   Proficiency with MES, LIMS, TrackWise, or similar systems.
-   Formal training in advanced RCA methodologies (Kepner‑Tregoe, Ishikawa, 5‑Why).
-   Experience mentoring and developing investigation talent.

## Benefits

-   12-month contract with possible extension
-   Administrative shift
-   Overtime availability