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

Lead Manufacturing Associate, Drug Product

Location / Division / Shift

At Viral Vector Services (VVS) a division of Thermo Fisher Scientific we deliver, from process development through commercial supply, we offer the expertise and resources vital to help clients deliver innovative gene therapies. Placed in the forefront of our leading- and innovative Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases.

Location: 5 Commerce Boulevard Plainville, MA

Shift: Day Shift Schedule: 12-Hour Rotating Shift (2/2/3 format) 7AM-7PM

Note: Rotating schedule starts once plant is in production

How will you make an impact?

The Lead Manufacturing Associate, Drug Product is an associate with a high level of technical expertise and experience. A viable candidate will independently perform routine operations commensurate with their experience and training. They support the day to day operation of a cGMP Manufacturing facility and improvement projects. They regularly own the training of other associates. This individual works collaboratively with the team as needed to complete the tasks assigned.

What you will do...

  • Lead up to 3-6 team members in the compliance execution of manufacturing activities.

  • Act as a high-level technician on the floor as needed. Performing sophisticated activities to include formulation, filtration, filling, visual inspection, labeling, and packaging.

  • Ensure compliance to following written procedures in operation of production equipment and performing processing steps.

  • Ensure team is practicing safe work habits and adheres to safety procedures and guidelines.

  • Complete aseptic operations within biosafety cabinets, filling lines, and cleanroom environments.

  • Accurately document activities in Batch Records, Logbooks, Forms, etc using good documentation practices.

  • Identify deviations to the processes and initiate quality records in compliance software.

  • Ability to perform basic troubleshooting and communicate issues per department guidelines.

  • Become a SME and qualified trainer on all operations.

  • Support continuous improvement in process operations and systems.

  • Review, revise, & author manufacturing batch records, SOPs, and work instructions.

  • Submit work requests through validated maintenance software.

  • Support investigations/activities with cross-functional teams as needed.

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

  • Involvement in commissioning, qualification, and validation of manufacturing equipment.

  • Lead tier meetings within department and communicate issues when appropriate.

How you will get there...

  • High School Diploma/GED with 5+ years experience or outstanding demonstration of skills, STEM/Biotechnology certificate preferred.

  • Bachelor's Degree in related field with 3+ years of proven experience.

  • Experience with working in clean or sterile environments, cleanrooms preferred.

Knowledge, Skills & Abilities

  • Strong interpersonal and communication skills (both verbal and written).

  • Strong attention to detail and strive to accomplish the job timely, accurately, and safely the first time is required.

  • Must have the ability to aseptically gown into the Manufacturing areas daily.

  • Will be regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; sit and to talk or hear.

  • Will be required to walk and stoop, or kneel, crouch.

  • May be required to lift, push, or pull up to 50 lbs.

  • Will be expected to meet the specific vision abilities required by this job which include close vision and ability to adjust focus with tasks.

At Thermo Fisher Scientific, each one of our 120,000+ 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.

“We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, company pension, and a range of employee benefits!

Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.”

“Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.

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.