Massachusetts Jobs

Manufacturing Associate III, 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 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.

Responsibilities

• Performs as a high-level technician providing mentorship to other technicians and driving daily operations! Provide critical evaluation of processes, including foresight and thinking ahead. Act as a guide to new employees during onboarding process. Has meaningful understanding of the job and applies knowledge and skills to complete a wide range of tasks.

• High Level Skilled: Aseptic Gowning / material flow, Applicable processing equipment, SAP/BLV. Works on assignments that are moderately difficult, requiring judgment in resolving issues or in making recommendations.

• High impact to work. Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines. Maintains compliance status required by company and facility standards.

• Stays up to date on required job training. Maintains up to date training records. Qualified trainer on sophisticated equipment/processes.

• SME on 1 Unit Operation. Acquires samples of batches/products according to SOPs; submits samples to required functional areas for testing and to resolve specific properties. Records/analyzes results and takes appropriate action.

• Responsible for the upkeep of manufacturing equipment. Recognizes equipment and product problems, notifies supervisor and/or troubleshoots errors in order to achieve optimum production levels.

• Review, revise, & author manufacturing batch records. Collaborate with Quality & PD to review & signoff on completed batch records. Be responsible for the batch record reconciliation. Review, revise, & Author WIs/SOPs.

• ·Enforce the Quality Management Systems by living the Quality values every day and holds peers across the site accountable as well. Assist with the timely closure of Nonconformance’s/ CAPAs

• Lead PPI initiatives and continuous improvements.

• Identify and communicate items requiring actions and follow-up decisions. Provide frequent feedback and coaching to others on ways to improve performance. Receives and checks raw materials and formulation deliveries and completes appropriate records in accordance with company procedures (MFP’s/EOP’s/LOP’s/SOP’s).

• Active participant of performance huddles and assist supervisors to plan out and populate process schedules.

• Maintain safety by identifying near misses, safety walkthroughs and assisting with resolution of safety observations. Ensure chemicals are properly stored and labeled.

• 90% of time spent on the floor

How you will get there...

Education/Experience/Equivalency:

• High School Diploma / 3+ years of relevant experience or superior demonstration of skills or background

• Bachelor’s Degree in related field / 1+ years of relevant experience or superior demonstration of skills or background.

Knowledge, Skills & Abilities

• Ability to lead and mentor.

• Understanding of the science behind the process with ability interpret data and inputs.

• Strong communication skills (verbal and written).

• Good autonomous problem-solving skills. Investigative skills.

• Understand cleanroom concepts. Ability to follow directions & procedures and work in team environment.

• Strong attention to detail and drive to accomplish the job timely, accurately and safely the first time is required, as well as the ability to work closely and effectively in a team environment.

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

• Must be fluent in english

• 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.