Manufacturing Associate II, Drug Product

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Job Title: Manufacturing Associate II, Drug Product

Location/Division Specific Information

Location: Lexington, MA

Shift Schedule/Hours: Monday – Friday 7:00 AM – 4:00 PM 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 you will make an impact…

The successful candidate will operate equipment used to manufacture drug product injectables in a cleanroom environment and following GMP standards. The Manufacturing Associate will autonomously run equipment, pumps, 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…

• Follow Safety & Environmental guidelines/policies as well as cGMP and other applicable regulatory agencies.
• Perform day to day manufacturing processes for Drug Product, including but not limited to:
• Final Formulation/Sterile Filtration
• Fill/Finish
• Visual Inspection
• Labeling
• Carry out work instructions while adhering to procedures and cGMP regulations.
• Inspect finished product to assure adherence to specifications such as appearance, foreign substances and packaging or labeling requirements as required.
• Perform manufacturing batch records reconciliation. Complete Preventative Maintenance & work notifications tasks on time.
• Support 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.
• Identify and complete continuous improvement opportunities.
• Maintain a strong safety culture by identification of near misses, safety walkthroughs and assisting with resolution of safety observations. Ensure chemicals are accurately stored and labeled.

How you will get here…

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

Education/Experience

• Bachelor’s degree with 0-3 years of cGMP industry experience
• Biotech program certificate or equivalent and 1-4 years of cGMP industry experience.
• High school diploma and 3-5 years of cGMP industry experience.

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 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 shift. Required to ascend/descend stairs approximately 20% of the time, lift max 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.
• Must be fluent in English

What we offer…

Excellent Benefit Package:

• Check out our benefits – Our Total Rewards
• Medical, Dental, & Vision benefits-effective Day 1
• Paid Time Off & Holidays
• Opportunities for career growth

At Thermo Fisher Scientific, each one of our 100,000 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.

Salary : $40 - $0