Senior Manufacturing Associate, Drug Substance

Position Title: Senior Manufacturing Associate, Drug Substance (Days)

Location: Lexington, MA

Shift: Day Shift Schedule: 12 Hour Rotating Shift (2/2/3 format) 6:45AM-7:15PM

Thermo Fisher Scientific’s Viral Vector Services (VVS) is a rapidly growing, dynamic gene therapy Contract Development and Manufacturing Organization (CDMO) that is seeking sharp individuals to bring the highest quality processes, products and testing to our clients. Our employees are committed to making a difference in our organization, for our client partners and the patients we serve. We are looking for top talent with proven competencies and strong character to join our team and help lead our organization into the future!

How will you make an impact?

The successful candidate will perform process operations, train new associates, maintain process areas in an inspection ready state and ensure proper stocking of materials to adhere to the production schedule, including discrete critical process steps. The Senior Associate will be expected to coach and mentor new associates in their area of operations and provide training as needed. The Senior Associate will be expected to support and facilitate on floor technical transfer of client processes for GMP manufacturing and support continuous improvement initiatives. The Senior Associate will support and encourage a culture of safety by adhering to site safety standards and the reporting of KPI’s.

What will you do?

• Provide process and technical leadership in the 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
• Review executed records and ensure compliance with cGMP requirements.
• Write and review operational SOP’s, work instruction and production batch records.
• Execute process operations and ensure adherence to production schedule.
• Support and encourage site safety initiatives and ensure safe work environment is maintained.
• Follows verbal and written procedures in operating production equipment and performing processing steps accurately completes appropriate production documentation.
• Identifies, escalates and documents events and subtle variances that deviate from normal operation participate as needed in investigations.
• Monitor processes using automated production systems and controls with limited supervision.
• Prepare, sanitize, and disinfect equipment as required for process operations.
• Troubleshoot basic mechanical operations.
• Conduct training for less experienced personnel.
• Fulfill role of lead trainer on numerous operations and is an area SME.
• Fulfill the role of Team Lead in the absence of the team supervisor.

How you will get here...

Education

Bachelor’s degree (Science, Technology, Engineering, or Math) Equivalent combinations of education, training, and relevant work experience may be considered HS diploma/ GED with additional relevant experience will be considered

Experience/Skills

• Minimum of 2 years of experience in pharmaceuticals manufacturing.
• Demonstrated ability to lead process operations (i.e. adherence to process schedule, assignment of tasks, process leadership, cross shift communication, and ability to trouble shoot equipment issues with oversight from area management, QA and other support groups).
• Thorough knowledge of cGMPs.
• Strong interpersonal and communications skills written and oral.
• Ability to function in a fast paced, dynamic environment with multiple priorities simultaneously.
• Ability to make decisions and work with minimal to moderate supervision.
• Able to adhere to all Personal Protective Equipment (PPE) requirements used within cGMP manufacturing.
• Able to lift at least 30 lbs and stand for several hours.
• Must be fluent in English

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.

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.

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Salary : $40 - $0