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 in a clean room environment (Remove if not relevant)
Preferred: Experience testing complex electromechanical systems (Remove if not relevant)

Knowledge, Skills, Abilities:

• 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/Factors:

• While performing the duties of this job, the employee:
• 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.
• While performing the duties of this job, the employee is required to write, read/review written documentation for extended periods of time. Specific vision requirements for this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
• Is regularly required to talk and hear. The employee frequently is required to sit and stand for extended periods. The employee is occasionally required to lift, stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and stoop, kneel, or crouch.

What We Offer:

·         Competitive Pay

·         Performance Related Bonus where eligible

·         Annual merit performance-based increase

·         Excellent Benefits

·         Medical benefits

·         Paid Time Off/Annual Leave

·         Employee Referral Bonus

·         Career Advancement Opportunities

Compensation and Benefits:

The hourly pay range estimated for this position based in Massachusetts is $32.00–$40.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (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
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com. 
 
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

I acknowledge that I understand the content of this job description and the expectations of the job position.

Compensation and Benefits

The hourly pay range estimated for this position based in Massachusetts is $26.39–$39.59.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs

• Employee assistance and family support programs, including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (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

• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards