Lead Manufacturing Associate - 1st Shift
Thermo Fisher Scientific
Lead Manufacturing Associate supporting cGMP drug product manufacturing operations at Thermo Fisher Scientific's Plainville facility. This role provides day-to-day process leadership, technical guidance, and operational oversight for gene therapy and viral vector contract manufacturing, including aseptic processing, filling, and formulation activities.
Responsibilities
- Provide technical coaching, guidance, and feedback to manufacturing colleagues on process execution and compliance
- Lead day-to-day drug product manufacturing activities including aseptic processing, filling, and formulation
- Coordinate with Manufacturing Supervisor on daily work plans, production priorities, and task assignments
- Identify, troubleshoot, and escalate process, equipment, safety, and quality issues timely
- Support investigations, deviations, CAPAs, and batch record reviews for GMP compliance
Requirements
- Strong technical knowledge of cGMP drug product manufacturing processes
- Experience with aseptic processing, filling, formulation, and visual inspection
- Demonstrated ability to lead, coach, and provide technical guidance to manufacturing teams
- Knowledge of GMP documentation, batch records, SOPs, and regulatory requirements
- Experience identifying, troubleshooting, and escalating process and quality issues
- Ability to work in classified cleanroom environments and operate manufacturing equipment
Vacancy posted 3 days ago
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