Location

Thermo Fisher Scientific site in Lexington Massachusetts

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 necessary to help clients deliver innovative gene therapies. Placed in the forefront of our leading and cutting edge Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases

How will you make an impact?

This position requires following defined procedures to perform basic to complex operations on the Upstream manufacturing process within a cGMP cleanroom commensurate with the individual’s level of technical expertise, training, and qualification.

Responsibilities include performing basic bioprocess manufacturing activities and operating bioprocessing equipment, meticulous documentation of performance, monitoring of processing equipment, processes, and control systems within a GMP cleanroom.

The Manufacturing Associate is expected to keep the GMP cleanroom in a constant state of inspection readiness and perform routine tasks such as cleaning, waste management, equipment maintenance, materials movement and other duties as assigned to assure the cleanroom and manufacturing systems are clean and inspection-ready at-all-times.

The Manufacturing Associate will adhere to all Safety and Quality standards of the organization contribute to continuous improvement in the areas of Safety, Quality, and Delivery.

What will you do?

Responsibilities

• Perform cGMP manufacturing activities according to standard operating procedures (SOPs) and batch records in accordance with assigned daily tasks and production schedule
• Meticulously maintain facility records, batch records, and process/system records as required throughout the manufacturing process according to GDP standards
• Through strict adherence to manufacturing controls, ensure finished drug substance/drug product and all intermediates comply with applicable regulatory requirements (e.g. FDA, EMA), cGMPs, QA/QC and safety standards
• Ability to learn biopharmaceutical manufacturing processes including but not limited to:
• Performing critical upstream activities drug substance manufacturing.
• Documentation of all activities in Batch Records, Logbooks, Forms, Etc.
• Adheres to the production schedule ensuring on-time delivery and efficient production logistics
• Other activities include keeping the GMP manufacturing facility in a state of inspection readiness, using performance tools (Human Performance), and routine housekeeping activities
• Work in accordance with site and company EHS programs.
• 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.

How will you get here?

Required

• Associate Degree in Life Sciences, Engineering, or Biotechnology or certificate program and one to three years’ industry related experience
• -High School diploma with 3-5 years of Upstream experience in cGMP manufacturing.

Preferred

• Bachelor’s Degree in science field with 1-3 years of Upstream experience
• cGMP Manufacturing experience preferred
• Cleanroom experience preferred
• Experience using SAP preferred

Knowledge, Skills, Abilities

• Strong interpersonal and communications skills; written and oral
• Solid understanding of applicable regulatory requirements
• Strong working knowledge of Microsoft Office
• Ability to deliver high quality documentation paying attention to detail
• The employee must frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds

Work Hours: The position is a 12-hour nighttime rotation after on-boarding is complete.

At Thermo Fisher Scientific, each one of our 75,000 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.

Apply today! http://jobs.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.