Manufacturing Associate Ii, Drug Substance

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...

• Execute work instructions while adhering to procedures and cGMP regulations.
• Perform day to day manufacturing processes for Drug Substance, including but not limited to:
• Adherent and suspension cell culture
• Adhere to Safety & Environmental guidelines/policies as well as cGMP and other applicable regulatory agencies.
• Chromatography and Tangential Flow Filtration
• 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.
• 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.
• Solution preparation
• Operation of Wave and disposable, single use Bio reactors
• Assist in the completion and identification of PPI initiatives and continuous improvements.
• Viral Filtration

How you will get here...

• Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.
• Ability to function in a fast paced, dynamic environment with multiple priorities simultaneously
• Strong planning, organization, and multitasking skills.

Education/Experience

• High school diploma required.
• An equivalent combination of education and experience may be considered
• Bachelor’s degree with 0+ years of cGMP industry experience preferred.
• Biotech program certificate or equivalent and 1+ years of cGMP industry experience preferred.

Knowledge, Skills, Abilities

• Understand the science behind the process with ability to interpret data and inputs.
• Must be fluent in English
• Ability to follow directions & procedures and work in a team environment.
• Ability to apply knowledge of Good Manufacturing processes and the knowledge and skills in pharmaceutical processes, equipment, instrumentation, and procedures.
• 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.
• Understand cleanroom concepts.

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. As 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.

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.

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