Lead Manufacturing Associate - 1st Shift

Thermo Fisher Scientific•Plainville, MA

17h•Onsite

About The Position

The Lead, Drug Product Manufacturing provides day-to-day process leadership and technical oversight for cGMP Drug Product manufacturing operations. In coordination 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 covers critical process steps and related activities, including aseptic processing, formulation, filling, visual inspection, and equipment operation. The Lead helps ensure work follows approved procedures, batch records, cGMP requirements, safety expectations, and production priorities. The Lead also supports colleague training and qualification, identifies and escalates process or compliance concerns, collaborates with cross-functional teams to resolve issues, and supports technical transfers and implementation of client processes for GMP manufacturing. The position is based in Plainville, Massachusetts, within the Drug Product Division, and is scheduled Monday through Friday from 7:00 a.m. to 3:30 p.m. Work includes coordinating and performing manufacturing activities in classified cleanrooms, using isolators, biosafety cabinets, and other controlled processing equipment. Activities include material preparation, formulation support, filling, visual inspection, cleaning and disinfection, line clearance, component preparation, environmental monitoring support, material transfers, equipment monitoring and troubleshooting, and accurate real-time GMP documentation. The role requires a high school diploma or equivalent and at least three years of work experience in manufacturing, operations, production, a laboratory setting, or a related field. A bachelor’s degree in Biochemistry, Biology, Mechanical Engineering, or Business Administration is preferred. Experience in cGMP and cleanroom environments is also preferred. The position requires strong knowledge of cGMP, aseptic manufacturing, contamination control, and cleanroom operations, as well as the ability to guide complex processes, troubleshoot issues, coordinate competing priorities, interpret manufacturing documentation, and collaborate across functions. The employee must be able to work in a dynamic environment, manage multiple priorities, learn software and tools quickly, make decisions with minimal to moderate supervision, and aseptically or sterile gown as needed. Duties involve extended periods of reading and reviewing documentation, sitting and standing, and occasional lifting, walking, reaching, handling objects, and stooping, kneeling, or crouching. Cleanroom standards prohibit hair products, jewelry, makeup, nail polish, perfume, exposed piercings, and facial hair. The posting lists hourly compensation ranges of $32.00–$40.00 and, elsewhere, $26.39–$39.59; the position may also be eligible for a variable annual performance bonus. Benefits include health and dental plans, vision coverage, PTO, paid holidays, parental leave, disability and life insurance, retirement savings, an employee stock purchase plan, commuter benefits, tuition reimbursement, and employee assistance and family support programs.

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 balance multiple priorities, learn new software and tools quickly, and make decisions with minimal to moderate supervision.
Ability to aseptically gown or sterile gown as needed.
Ability to read and review written documentation for extended periods.
Vision requirements include close, distance, color, peripheral, and 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 handle or feel, reach, and stoop, kneel, or crouch.
Must adhere to GMP and safety standards, including cleanroom restrictions on hair products, jewelry, makeup, nail polish, perfume, exposed piercings, and facial hair.

Nice To Haves

Bachelor’s degree in Biochemistry, Biology, Mechanical Engineering, or Business Administration.
Experience in a cGMP environment.
Experience working in a cleanroom environment.
Experience testing complex electromechanical systems.

Responsibilities

Provide day-to-day technical leadership and direction for Drug Product manufacturing activities.
Coach colleagues on the manufacturing floor, provide constructive feedback, and support training and qualification.
Coordinate with the Manufacturing Supervisor on daily work plans, production priorities, task assignments, Tier 1 operational status, and escalation of constraints.
Serve as a technical resource for formulation, filling, aseptic processing, visual inspection, equipment operation, and related activities.
Lead or support critical and complex process steps in accordance with batch records, SOPs, cGMP requirements, and site safety procedures.
Identify, troubleshoot, and escalate process, equipment, documentation, safety, and quality issues.
Support initiation, investigation, and resolution of deviations and CAPAs, and contribute technical input to root-cause analysis.
Review and support development or revision of batch records, SOPs, forms, work instructions, and other GMP documentation.
Verify that manufacturing work follows approved procedures and escalate compliance concerns to the Supervisor or Quality.
Identify and implement process improvements in safety, quality, efficiency, Right First-Time performance, and operational reliability.
Partner with Quality, Engineering, Validation, MSAT/Process Development, Supply Chain, and other functions on manufacturing execution, investigations, equipment qualification, and continuous improvement.
Support technical transfer and introduction of new client processes into GMP manufacturing.
Represent Drug Product Manufacturing as a technical delegate in operational or client meetings when appropriate.
Coordinate and perform cleanroom manufacturing work, including aseptic setup, material preparation, formulation support, filling, and related operations using isolators, biosafety cabinets, and controlled processing equipment.
Operate, monitor, clean, and help troubleshoot manufacturing equipment and automated systems.
Perform visual inspection of finished Drug Product, identify and segregate defects, complete required documentation, and support inspection activities.
Perform cleanroom and equipment activities such as cleaning, disinfection, line clearance, component preparation, environmental monitoring support, and material transfers while maintaining gowning and contamination-control practices.
Complete batch records, logbooks, forms, and other GMP documentation accurately and in real time.

Benefits

Competitive pay.
Performance-related bonus where eligible and potential variable annual bonus based on company, team, and/or individual performance.
Annual merit performance-based increase.
Medical, dental, and vision plans, including health incentive programs.
Paid time off of at least 120 hours and 10 paid holidays annually.
Paid parental leave, including bonding and caregiver leave.
Accident and life insurance, and short- and long-term disability coverage.
Employee assistance and family support programs.
Commuter benefits.
Tuition reimbursement.
Competitive 401(k) retirement savings plan.
Employee stock purchase plan with an opportunity for eligible colleagues to purchase company stock at a discount.
Employee referral bonus.
Career advancement opportunities.