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Thermo Fisher Scientific Lead Manufacturing Associate, Drug Product in Plainville, Massachusetts

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

How will you make an impact?

As part of Thermo Fisher’s Viral Vector Services organization in Plainville, the Lead Manufacturing Associate of Drug Product is responsible for the formulation, filling, and component preparation activities required for viral vector manufacturing. This position will play a vital role in plant start-up activities in preparation for drug product commercial manufacturing operations. He/she provides cross functional support, operations acumen, and results focus to reliably meet timelines and due dates in a fast-paced production environment.

  • Plainville, MA (5 Commerce Boulevard): In this role you will help support and execute the large capital facility project through the construction of a new state-of-the-art commercial manufacturing facility.

  • Shift: 12/hour rotating shift from 7AM – 7PM or 7PM-7AM

What will you do?

  • Performing basic to complex activities on the fill finish line for production of Drug Product.

  • Documentation of all activities in Batch Records, Logbooks, Forms, Etc.

  • Follows verbal and written procedures in operating production equipment and performing processing steps; accurately completes appropriate production documentation.

  • Identifies, escalates and documents events and subtle variances that deviate from normal operation; participate as needed in investigations.

  • Monitor assigned processes using automated production systems and controls with limited supervision.

  • Equipment preparation activities including, parts cleaning, autoclaving, and room clearance.

  • Demonstrates ability to troubleshoot basic to advanced mechanical operations.

  • Post-Fill tasks will include visual inspection, secondary packaging, and environmental monitoring.

  • Daily Aseptic processing within a controlled isolator environment and within a BSC.

  • Performs batch record review, procedure revisions, and work order generation.

  • Fulfills role of lead trainer on numerous operations and is an area SME.

  • Fulfills the role of Team Lead in the absence of the team supervisor. Responsible for assignment of duties to all team members, ensuring execution of duties, communicating at daily scheduling meetings, and providing technical support as needed.

  • Work in accordance with site and company EHS programs.

  • Work in accordance with regulations, detailed protocols, Batch Record’s, SOP’s and Work Instructions.

  • Prepare and process components, materials and equipment for aseptic fill finish activities, operate filling equipment and perform aseptic manipulations, able to inspect finished vials and perform labeling activities to support shipment.

  • Supports equipment, documentation, investigations and improvement initiatives within manufacturing operations.

How will you get there?

  • High School / GED Required with 2-4 years of related industry work experience. Bachelor’s Degree in Business or Life Sciences is desired.

  • Understands aseptic processing, environmental controls and automated filling systems.

  • Understands inspection of filled vials, labeling and vial reconciliation requirements.

  • Thorough knowledge of cGMP.

  • Ability to function in a fast paced, dynamic environment with multiple priorities simultaneously.

  • Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.

  • Strong planning, organization and multitasking skills.

  • Adhere to all Personal Protective Equipment (PPE) requirements used within cGMP manufacturing.

  • Demonstrated ability to manage cross-functional teams and collaborate across the business. Strong analytical and problem solving skills; great attention to detail and excellent decision making process.

  • Expertise in managing small and medium technical and/or capital projects.

  • Recognize, understand and respond to situations requiring further evaluation and report these events (process, safety, personnel, etc..) to manufacturing or area management.

  • Ability to work 12 hour shifts on a rotating schedule.

PHYSICAL DEMANDS/FACTORS:

While performing the duties of this job, the employee:

  • Gown aseptically and/or sterile gown as needed.

  • 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.

  • 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.

At Thermo Fisher Scientific, each one of our 80,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

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.

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