Lead Manufacturing Associate - 1st Shift

Thermo Fisher Scientific•Plainville, MA

1d•$26 - $40•Onsite

About The Position

The Lead, Drug Product Manufacturing provides day-to-day process leadership and technical oversight for cGMP Drug Product manufacturing operations. Working with the Manufacturing Supervisor, the Lead supports safe, compliant, and efficient manufacturing 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 role provides process expertise across Drug Product manufacturing, including aseptic activities, formulation, filling, visual inspection, and associated support activities. It helps ensure work follows approved procedures, batch records, cGMP requirements, safety expectations, and production priorities. The Lead is a technical resource for colleagues, supports training and qualification, identifies and escalates process or compliance concerns, partners with the Supervisor and cross-functional teams to resolve operational issues, and supports technical transfers and implementation of client processes for GMP manufacturing. The position is based in Plainville, Massachusetts, in the Drug Product Division, and follows a Monday–Friday, 7:00 a.m.–3:30 p.m. schedule. Work includes performing Drug Product manufacturing activities in classified cleanroom environments, operating and supporting manufacturing equipment and automated systems, visual inspection of finished products, cleanroom and equipment activities, and accurate completion of GMP documentation. Cleanroom work requires adherence to GMP safety standards and restrictions on items such as hair products, jewelry, makeup, nail polish, perfume, exposed piercings, and facial hair. A high school diploma or equivalent is required. A bachelor's degree in Biochemical studies, Biology, Mechanical Engineering, or Business Administration is preferred. At least three years of work experience in manufacturing, operations, production, a laboratory setting, or a related field is required. Experience in a cGMP environment and cleanroom environment is preferred.

Requirements

High school diploma or equivalent required.
At least 3 years of work experience in a manufacturing, operations, production, laboratory setting, or related field.
Strong working knowledge of cGMP requirements, aseptic manufacturing practices, contamination control, and cleanroom operations.
Ability to independently execute and provide technical guidance for complex manufacturing processes.
Ability to recognize abnormal process conditions, troubleshoot operational issues, and determine when escalation is required.
Ability to coordinate multiple manufacturing activities and priorities in a dynamic production environment.
Strong technical communication skills and ability to provide clear direction during manufacturing execution.
Ability to interpret batch records, SOPs, equipment documentation, and process requirements.
Ability to collaborate effectively with Quality and other cross-functional partners.
Ability to lead through technical expertise and influence without direct people-management authority.
Ability to function in a dynamic environment and balance multiple priorities simultaneously.
Ability to learn new software and tools quickly.
Ability to make decisions and work with minimal to moderate supervision.
Ability to aseptically gown and/or sterile gown as needed.
Ability to write, read, and review written documentation for extended periods; specific vision requirements include close, distance, color, and peripheral vision, depth perception, and ability to adjust focus.
Regularly required to talk and hear; frequently required to sit and stand for extended periods; occasionally required to lift, walk, use hands to finger, handle, or feel, reach with hands and arms, and stoop, kneel, or crouch.

Nice To Haves

Bachelor's degree in Biochemical studies, Biology, Mechanical Engineering, or Business Administration.
Experience in a cGMP environment.
Experience working in a cleanroom environment.

Responsibilities

Provide technical coaching, on-floor guidance, and constructive feedback to manufacturing colleagues; escalate performance, conduct, or personnel concerns to 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 for formulation, filling, aseptic processing, visual inspection, equipment operation, and related manufacturing activities.
Lead or support 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, contributing 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 and production status, and escalate operational constraints.
Support training and qualification of manufacturing colleagues through technical instruction, demonstration, and on-floor guidance.
Verify manufacturing activities follow 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.
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, and other controlled processing equipment.
Operate, monitor, clean, and support troubleshooting of manufacturing equipment and automated systems while following approved procedures, batch records, aseptic techniques, cGMP requirements, and site safety procedures.
Perform visual inspection of finished Drug Product, identify and segregate defects, complete required documentation, and support inspection-related activities in accordance with approved procedures and quality requirements.
Perform 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.
Complete batch records, logbooks, forms, and other GMP documentation accurately and in real time in accordance with Good Documentation Practices.
Collaborate with Manufacturing, Quality, Engineering, Validation, and other cross-functional teams on investigations, deviations, CAPAs, equipment qualifications, process improvements, and continuous improvement initiatives.

Benefits

Competitive pay.
Performance-related bonus where eligible.
Annual merit performance-based increase.
Medical benefits, including a choice of national medical plans and health incentive programs.
Dental insurance and a national vision plan.
Paid time off/annual leave, including at least 120 hours of PTO and 10 paid holidays annually.
Employee referral bonus.
Career advancement opportunities.
Employee assistance and family support programs, including commuter benefits and tuition reimbursement.
Paid parental leave, including 3 weeks for bonding and 8 weeks for caregiver leave.
Accident and life insurance, and short- and long-term disability in accordance with company policy.
401(k) U.S. retirement savings plan.
Employee Stock Purchase Plan offering eligible colleagues the opportunity to purchase company stock at a discount.