Lead Manufacturing Associate - 1st Shift

Work Schedule First Shift (Days) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office Job Description As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Every day, our colleagues bring our Mission to life by helping our customers make the world healthier, cleaner and safer. Through our work, we support solutions to some of the world’s toughest challenges, from advancing life-saving therapies and protecting the environment to helping ensure the safety of our food supply. At Thermo Fisher Scientific, your work has a real impact. You’ll be part of a global team committed to scientific progress, customer success, and improving the lives of patients, while also receiving the resources and support needed to achieve your individual career goals. Thermo Fisher Scientific Viral Vector Services (VVS) / Drug Product Division (DPD) is a dynamic and growing gene therapy contract development and manufacturing organization. Our colleagues are committed to making a difference for our organization, our client partners, and the patients we serve. We are looking for talented individuals with strong technical capabilities, demonstrated competencies, and a commitment to our values to join our team and help shape the future of our organization. Location / Division / Shift Location/Division Specific Information: Plainville, MA Business Unit : Drug Product Division Schedule: M-F 7:00am to 3:30pm How Will You Make an Impact? The Lead, Drug Product Manufacturing provides day-to-day process leadership and technical oversight for cGMP Drug Product manufacturing operations. Working in coordination with the Manufacturing Supervisor, the Lead supports safe, compliant, and efficient execution of manufacturing activities by providing technical guidance, coordinating workflow, maintaining process readiness, and serving as a primary point of contact for operational issues on the manufacturing floor. The Lead will provide process expertise across Drug Product manufacturing operations, including critical process steps, aseptic activities, formulation, filling, visual inspection, and associated support activities. The Lead will help ensure manufacturing activities are performed in accordance with approved procedures, batch records, cGMP requirements, safety expectations, and production priorities. The Lead serves as a technical resource for manufacturing colleagues, supports training and qualification activities, identifies and escalates process or compliance concerns, and partners with the Supervisor and cross-functional teams to resolve operational issues. The Lead will also support technical transfers and implementation of client processes for GMP manufacturing. What will you do? Provide technical coaching, on-the-floor guidance, and constructive feedback to manufacturing colleagues to support consistent process execution, training, and compliance. Escalate performance, conduct, or personnel concerns the Manufacturing Supervisor as appropriate. Provide day-to-day process leadership and technical direction for Drug Product manufacturing activities. Partner with the Manufacturing Supervisor to coordinate daily work plans, communicate production priorities, support task assignments, maintain Tier 1 operational status, and provide process leadership on and off the manufacturing floor. Serve as a primary technical resource on the manufacturing floor for formulation, filling, aseptic processing, visual inspection, equipment operation, and associated manufacturing activities. Lead or support execution of critical and complex process steps in accordance with approved batch records, SOPs, cGMP requirements, and site safety procedures. Identify, troubleshoot, and escalate process, equipment, documentation, safety, and quality issues in a timely manner. Support initiation, investigation, and resolution of deviations and CAPAs and contribute technical input to investigations and root-cause analysis. Review batch records, SOPs, forms, work instructions, and other manufacturing documentation to support operational readiness and campaign execution. Support development and revision of SOPs, batch records, work instructions, and other GMP documentation. Maintain Tier 1 priorities, production status, and escalation of operational constraints. Support training and qualification of manufacturing colleagues by providing technical instruction, demonstration, and on-the-floor guidance. Verify that manufacturing activities are being executed in accordance with approved procedures and escalate compliance concerns to the Supervisor or Quality as appropriate. Identify and implement process improvements that enhance safety, quality, efficiency, Right First-Time performance, and operational reliability. Partner with Quality, Engineering, Validation, MSAT/Process Development, Supply Chain, and other functions to support manufacturing execution, equipment qualification, investigations, and continuous improvement. Support technical transfer and introduction of new client processes into GMP manufacturing. Represent Drug Product Manufacturing in operational or client meetings as a technical delegate when appropriate. A Day in the Life: Lead, coordinate, and when required directly perform Drug Product manufacturing activities in classified cleanroom environments, including aseptic setup, material preparation, formulation support, filling, and related operations using isolators, biosafety cabinets (BSCs), and other controlled processing equipment. Operate, monitor, clean, and support troubleshooting of manufacturing equipment and automated systems while following approved SOPs, batch records, aseptic techniques, cGMP requirements, and site safety procedures. Perform visual inspection of finished Drug Product, including identification and segregation of defects, completion of required documentation, and support of inspection-related activities in accordance with approved procedures and quality requirements. Execute routine cleanroom and equipment activities such as cleaning, disinfection, line clearance, component preparation, environmental monitoring support, and material transfers while maintaining proper gowning and contamination-control practices. Accurately complete batch records, logbooks, forms, and other GMP documentation in real time and in accordance with Good Documentation Practices (GDP). Collaborate with Manufacturing, Quality, Engineering, Validation, and other cross-functional teams to support investigations, deviations, CAPAs, equipment qualifications, process improvements, and continuous improvement initiatives. Education: High school diploma or equivalent required. Bachelor’s degree: Biochemical, Biology, Mechanical Engineering, Business Administration preferred Experience: Required: Minimum of 3 years of work experience in a manufacturing, operations, production, lab setting or related field Preferred: Experience in a cGMP environment Preferred: Experience working