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Job Description

Sr. Manufacturing Associate, Drug Product

Location/ Division/ S hift

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.

Locati o n: 5 Commerce Boulevard Plainville, MA

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

No t e : Rotating schedule starts once plant is in production.

How will you make an impact ?

The Sr. Manufacturing Associate, Drug Product operates equipment used to manufacture products. This position will be fully trained to and proficient at manufacturing drug product injectables in a cleanroom environment and will follow GMP standards. A successful candidate will operate the filling line, perform visual inspection, and collaborate with team members on processes as needed. They will support the day to day operation of a cGMP Manufacturing facility and provide input to process improvements.

What vou will do . . .

• Adhere to SOP's, Batch Records, and Work Instructions by living the Quality values every day and holds peers across the site accountable as well.

• SME on at least 1 unit operation: Will become qualified trainer and train new hires within the department.

• Submit work requests through validated maintenance software.

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

• Fully trained on all unit operations associated with the department. Works on assignments that are semi-routine in nature but receives instruction on new processes that are accepted practices.

• Maintains inventory records of raw materials used in batch manufacturing. Keeps accurate and up-to-date batch records and data sheets on batches in process.

• Inspect finished product to assure adherence to specifications such as appearance, foreign substances and packaging or labeling requirements.

• Assist in the completion and identification of PPI initiatives and continuous improvements

• Identify and communicate concerns in a timely manner.

• Maintain a culture of safety by identification of near misses, safety walkthroughs and assisting with resolution of safety observations.

• Performs transactions in SAP in real-time.

• 90% of time spent on the floor in cleanroom environment.

How vou will get th ere.. .

• High School Diploma with 3+ years of experience or outstanding demonstration of skills or background, STEM/Biotechnology certificate preferred.

• Bachelor's Degree in related field with 1+ years of proven experience.

• An equivalent combination of education and experience may be considered.

K n ow l ed g e , S k i ll s & A b il iti es

• 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.

• Must be fluent in English

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.

A pp l y to d ay ! http://jobs . thermofisher.com

"We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, company pension, and a range of employee benefitslThermo 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.