Lead Manufacturing Associate - 1st Shift

Schedule

First Shift (Days), Monday–Friday, 7:00 am–3:30 pm.

Environmental Conditions

• Adherence to all Good Manufacturing Practices (GMP) and Safety Standards.
• Cleanroom environment: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, or facial hair permitted.

About the Role

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 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 role spans formulation, filling, aseptic processing, visual inspection, and associated support activities, ensuring all work follows approved procedures, batch records, cGMP requirements, safety expectations, and production priorities. The Lead also supports technical transfers and implementation of client processes for GMP manufacturing.

Responsibilities

• 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 to the Manufacturing Supervisor as appropriate.
• Deliver 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 floor.
• Serve as a primary technical resource for formulation, filling, aseptic processing, visual inspection, equipment operation, and associated manufacturing activities.
• Lead or support execution of critical and complex process steps per 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; 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 through technical instruction, demonstration, and on‑the‑floor guidance.
• Verify manufacturing activities comply with approved procedures; 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 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 troubleshoot manufacturing equipment and automated systems per 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 per 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 per 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.

Requirements

Education

• High school diploma or equivalent required.
• Bachelor’s degree in Biochemical, Biology, Mechanical Engineering, Business Administration, or related field preferred.

Experience

• Minimum 3 years of work experience in a manufacturing, operations, production, lab setting, or related field (required).
• Experience in a cGMP environment (preferred).
• Experience working in a cleanroom environment (preferred).
• Experience testing complex electromechanical systems (preferred).

Skills

• Strong working knowledge of cGMP requirements, aseptic manufacturing practices, contamination control, and cleanroom operations.
• Demonstrated 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.
• Demonstrated ability to collaborate effectively with Quality and other cross‑functional partners.
• Ability to lead through technical expertise and influence without direct people‑management authority.

Physical Demands

• 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.
• Extended periods of writing, reading, and reviewing written documentation.
• Specific vision requirements: close vision, distance vision, color vision, 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, stand, walk, use hands to finger, handle, or feel, reach with hands and arms, and stoop, kneel, or crouch.

Benefits & Compensation

• Hourly pay range: $32.00–$40.00 (Massachusetts estimate); also noted as $26.39–$39.59 in a separate compensation section.
• Variable annual bonus based on company, team, and/or individual performance per company policy.
• Comprehensive Total Rewards package including:
  • Choice of national medical