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Manufacturing Associate II, Drug Substance

Thermo Fisher Scientific

Thermo Fisher Scientific

Lexington, MA, USA
Posted on Friday, May 26, 2023

Job Description

Job Title: Manufacturing Associate II, Drug Substance

Location: Lexington, MA

Shift: 12 Hour rotating shift (2/2/3 format) 6:45AM-7:15PM position. Flexible hours are sometimes vital to accommodate project/production demand when required.

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

How will you make an impact?

The successful candidate will operate equipment used to manufacture drug substance in a cleanroom environment and following GMP standards. The Manufacturing Associate will autonomously run equipment, Skids, pumps, Bio-reactors and automated systems and collaborate with team members to ensure it's right the first time and on schedule, while also following SOPs and batch records and recommending opportunities for improvement.

What you will do...

  • Adhere to Safety & Environmental guidelines/policies as well as cGMP and other applicable regulatory agencies
  • Perform manufacturing process operations for Drug Substance, including but not limited to: Solution preparation, Adherent and suspension cell culture, Operation of Wave and disposable, single use Bio reactors, Chromatography and Tangential Flow Filtration & Viral Filtration
  • Execute work instructions while adhering to procedures and cGMP regulations.
  • Assist with manufacturing batch records reconciliation. Complete Preventative Maintenance & work notifications tasks on time.
  • Adhere to the Quality Management Systems by living the Quality values every day and holds peers across the site accountable as well. Assist with the on time closure of Nonconformance’s/ CAPAs and investigations.
  • Assist in the completion and identification of PPI initiatives and continuous improvements.
  • Maintain a culture of safety by identification of near misses, safety walkthroughs and assisting with resolution of safety observations. Ensure chemicals are properly stored and labeled.

How you will get here...


  • Minimum of a High school diploma required
  • Industry experience not required, however cGMP and or clean room experience is preferred

Knowledge, Skills, Abilities

  • Ability to apply knowledge of Good Manufacturing processes and the knowledge and skills in pharmaceutical processes, equipment, instrumentation, and procedures.
  • Ability to follow procedures and work in a team environment.
  • Understand the science behind the process with ability to interpret data and inputs.
  • Understand cleanroom concepts.
  • Ability to regularly stand; use hands to finger, handle, or feel; reach with hands and arms; sit and to talk or hear. Required to walk and stoop, or kneel, crouch approximately 80% of the time. Required to ascend/descend stairs approximately 20% of the time, lift a maximum of 50lbs., and sit for a maximum of 4 hours.
  • Specific vision abilities required by this job include close vision and ability to adjust focus with tasks.
  • Ability to function in a fast paced, dynamic environment with multiple priorities simultaneously
  • Strong planning, organization, and multitasking skills.
  • Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.
  • Must be fluent in English


We offer competitive remuneration, annual incentive plan bonus, healthcare, 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!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. A one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.