Lead Formulation Technician

Work Schedule

Environmental Conditions

Job Description

Lead Manufacturing Associate Support Services

Location / Division / Shift

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

Location:5 Commerce Boulevard Plainville MA
Shift:Day Shift Schedule: 12-Hour Rotating Shift (2/2/3 format) 7AM-7PM Current Interim schedule is M-F: 6:30- 3:30PM
Note: Rotating schedule starts once plant is in production

How will you make an impact

The Lead Manufacturing Associate Support Services is an associate with a high level of technical expertise and experience. A viable candidate will independently perform routine operations commensurate with their experience and training. They support the day-to-day operation of a cGMP Manufacturing facility and improvement projects. They regularly own the training of other associates. This individual works collaboratively with the team as needed to complete the tasks assigned.

What you will do...

• Lead up to 6 team members in the compliance execution of manufacturing activities.
• Act as a high-level technician on the floor as needed. Performing sophisticated activities to include Weigh and Dispense Solution Prep and Autoclave operations.
• Ensure compliance to following written procedures in operation of production equipment and performing processing steps.
• Ensure team is practicing safe work habits and adheres to safety procedures and guidelines.
• Complete aseptic operations within biosafety cabinets.
• Accurately document activities in Batch Records Logbooks Forms etc using good documentation practices.
• Identify deviations to the processes and initiate quality records in compliance software.
• Ability to perform basic troubleshooting and communicate issues per department guidelines.
• Become a SME and qualified trainer on all operations.
• Support continuous improvement in process operations and systems.
• Review revise & author manufacturing batch records SOPs and work instructions.
• Submit work requests through validated maintenance software.
• Support investigations/activities with cross-functional teams as needed.
• Monitor processes using automated production systems and controls with limited supervision.
• Involvement in commissioning qualification and validation of manufacturing equipment.
• Lead tier meetings within department and communicate issues when appropriate.

How you will get there...

• High School Diploma/GED with 5 years experience or outstanding demonstration of skills STEM/Biotechnology certificate preferred.
• Bachelors Degree in related field with 3 years of proven experience.
• Experience with working in clean or sterile environments cleanrooms preferred.

Knowledge Skills & Abilities

• Strong interpersonal and communication skills (both verbal and written).
• Strong attention to detail and strive to accomplish the job timely accurately and safely the first time is required.
• Must have the ability to aseptically gown into the Manufacturing areas daily.
• Will be regularly required to stand; use hands to finger handle or feel; reach with hands and arms; sit and to talk or hear.
• Will be required to walk and stoop or kneel crouch.
• May be required to lift push or pull up to 50 lbs.
• Will be expected to meet the specific vision abilities required by this job which include close vision and ability to adjust focus with tasks.

At Thermo Fisher Scientific each one of our 120000 extraordinary minds has a unique story to tell. Join us and contribute to our singular missionenabling our customers to make the world healthier cleaner and safer.

We offer competitive remuneration annual incentive plan bonus scheme healthcare company pension 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.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate based on race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other legally protected status.