Job Title: Manufacturing Associate 1

Requisition ID:131267BR

Location: Lexington MA

How will you make an impact?

(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 necessary to help clients deliver innovative gene therapies. Placed in the forefront of our leading and cutting edge Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases

What will you do?

Position Description/Summary

Responsible for cGMP Upstream manufacturing operations at the Viral Vector Services Thermo Fisher Scientific Lexington, MA

What will you do?

Responsibilities:

• Executing aseptic operations within a biosafety cabinet and cleanroom environment.
  Performing operations in an aseptic seed lab, operating Wave bioreactors,
• operating adherent / stir tank bioreactors.
  Good Documentation Practices for all activities within controlled batch documentation (Batch Records, Logbooks, Forms, Etc.)
• 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 / semi-automated production systems and controls with limited supervision.
  Equipment preparation, sanitation and disinfection.
• Demonstrates ability to troubleshoot basic biotechnical operations.
• Work in accordance with site and company EHS programs.
  Work in accordance with regulations, detailed protocols, Batch Record’s, SOP’s and Work Instructions.

  How will you get here?

• Independently motivated and can work within a cross-functional team

• Work Hours
• The position is a 12-hour day rotational shift that may require overtime to work evenings, weekends or holidays, as required to meet project timelines. Requirements:

Education

Minimum Qualifications:

High School diploma and 2-4 years’ industry related experience in cGMP manufacturing.

Preferred Qualifications:

Bachelor’s Degree with 2-4 years of Upstream experience in cGMP manufacturing.
High School diploma with 3-5 years of Upstream experience in cGMP manufacturing.

Experience

• 2-4 years’ industry related experience in cGMP Manufacturing

Knowledge, Skills, Abilities

• Must be able to work in a fast-paced environment.
• A strong attention to detail.
• Solid understanding of aseptic principles.
• Work towards solutions to given problems and operate under cGMP requirements.
• Work cross-functionally with support groups such as Facilities, Engineering, Contamination Control, Quality Control and Quality Assurance.
• Qualify to work in aseptic environments to complete required production activities.
• Maintain facility and room inspection readiness.
• Ability to lift at least 50lbs.
• Ability to aseptically gown and/or sterile gown as needed

Note: This job description is not all-inclusive. Additional duties may be performed, as assigned. It acts as a guideline and is subject to change over time. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here for further assistance.

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 legal protection

At Thermo Fisher Scientific, each one of our 75,000 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.