Senior Staff, Manufacturing Technical Operations
Boston, MA
Job Type: Contract | Recruiter: Hillary Bergstrom | Phone: 603-772-2700
Location: Boston, MA (Onsite)
Length: 6+ months
Job Description:
Our client is seeking a highly skilled and experienced Senior Staff, Manufacturing Technical Operations (MTO) to join their team. This position is critical to ensure the smooth operation and compliance of cell manufacturing processes. The ideal candidate will have extensive experience in managing quality records, investigations, and fostering cross-functional collaboration to meet the demands of a fast-paced, clinical manufacturing environment. In this role you will contribute to the success of cutting-edge gene and cell therapies, while working in close partnership with various departments to ensure compliance and continuous improvement.
Essential Duties and Responsibilities (but not limited to):
- Triage and resolve real-time manufacturing issues on the floor, utilizing root cause analysis tools to lead investigations into quality events across cell manufacturing, quality control, material operations, and facility operations.
- Own and manage quality records (deviations, CAPAs, Risk Assessments, and Change Controls) in the electronic Quality Management System (eQMS), ensuring timely completion and adherence to GMP standards.
- Collaborate with subject matter experts (SMEs) to assess immediate corrective actions, containment strategies, and conduct impact assessments.
- Lead cross-functional root cause analysis meetings to drive corrective and preventive actions (CAPAs) through to resolution.
- Track and distribute key performance metrics, support MTO intake and prioritization, and contribute to continuous process improvements and operational compliance.
- Promote and implement MTO and QA-aligned best practices to ensure compliance and enhance operational effectiveness.
- Support the development and training of SOPs and guidelines for MTO activities.
- Undertake other assigned projects to meet departmental needs and clinical timelines.
- Bachelor’s degree (or higher) in Engineering, Science, or a related discipline is required.
- 6+ years of progressive experience in pharmaceutical development and manufacturing, ideally in a clinical or GMP-compliant environment.
- Proven expertise in leading event investigations, managing quality records, and driving corrective actions in a regulated industry.
- Strong technical writing skills with the ability to document investigations, CAPAs, deviations, and risk assessments clearly and thoroughly.
- Excellent planning, organizational, and time management skills, with the ability to balance production and development needs in a fast-paced environment.
- Experience working in a Grade B (cleanroom) manufacturing environment, including gowning and compliance with strict GMP standards.
- Flexibility in schedule to support cell manufacturing clinical hours and timelines.
- Ability to work collaboratively with cross-functional teams and foster a culture of compliance and continuous improvement.
Make this your next career move as one of our many long-term contractors or employees!
- Work as our full-time employee with full benefits (Medical, Dental, Vision, Life, STD, LTD, PTO, etc.) - OR - work as a W2 hourly contractor at a higher pay rate if you don't need the benefit package.
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- Voted ‘Best Staffing Firm to Temp/Contract For’ seven times by Staffing Industry Analysts as well as a ‘Best Company to Work For’ by Forbes, Fortune and Inc. magazine.
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