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?
- 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.
Work Hours: The position is a 12-hour nighttime rotation after on-boarding is complete.
How will you get here?
- Must be able to make decisions for moderately complex GMP manufacturing activities including process performance with minimal to moderate supervision.
- Must be able to recognize, understand and respond to situations requiring further evaluation and report these events (process, safety, personnel, etc..) to senior operators or area management.
- Must be able to provide effective written or verbal communication to peers, senior associates, and area management within their operational group .
- Must be able to understand operational documents for GMP compliance, accuracy and completeness.
- Must safely perform activities on the shift in order to prevent releases, accidents and injuries.
Education and Qualifications:
- Bachelor’s Degree in science field with 0-1 years of Upstream experience
- Associate Degree in Life Sciences, Engineering, or Biotechnology or certificate program and 1-2 years’ of Upstream experience
- Solid understanding of applicable regulatory requirements.
- High School Diploma / minimum 1+ years of relevant experience or superior demonstration of skill sets or background
- Strong interpersonal and communications skills; written and oral
- 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.
- Ability to aseptically gown and/or sterile gown as needed.
- 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 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.