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Featured Employers
Associate I, MFG Drug Product
Company: Thermo Fisher Scientific
Location: Lexington, MA
Employment Type: Full Time
Date Posted: 01/11/2021
Expire Date: 03/06/2021
Job Categories: Healthcare, Other, Information Technology, Manufacturing and Production, Quality Control, Research & Development, Medical, Environmental
Job Description
Associate I, MFG Drug Product

At Viral Vector Services (VVS) a division of Thermo Fisher Scientific we deliver, from process development through commercial supply, 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

How will you make an impact?

Responsible for cGMP manufacturing of Drug Product as a member of the Thermo Fisher Scientific site in Lexington Massachusetts.

What will you do?

  • Performing basic to complex activities on the fill finish line for production of Drug Product.
  • Performing critical downstream activities in preparation for fill finish of Drug Product.
  • Documentation of all activities in 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 production systems and controls with limited supervision.
  • Equipment preparation activities including parts cleaning, autoclaving, and room clearance.
  • Demonstrates ability to troubleshoot basic mechanical operations.
  • Post-Fill tasks will include visual inspection, secondary packaging, and environmental monitoring.
  • Daily Aseptic processing within a controlled isolator environment and within a BSC.
  • Conducts training for less experienced personnel
  • The incumbent will onboard and support project and Manufacturing activities Monday through Friday, 7:00 AM to 4:00 PM.
  • May require overtime to work evenings, weekends or holidays, as required to meet project/Manufacturing timelines.
  • Work in accordance with site and company EHS programs.
  • Work in accordance with regulations, detailed protocols, Batch Record’s, SOP’s and Work Instructions.
  • Prepare and process components, materials and equipment for aseptic fill finish activities, operate filling equipment and perform aseptic manipulations, able to inspect finished vials and perform labeling activities to support shipment.

How will you get here?

Education

  • Minimum Qualifications - High School diploma and 2-4 year’s industry related experience in cGMP manufacturing.
  • Preferred Qualifications - Bachelor’s Degree with 2-4 years of Drug Product experience in cGMP manufacturing or a High School diploma with 3-5 years of Drug Product experience in cGMP manufacturing.

Experience

  • Drug Product / Fill Finish
  • cGMP
  • Aseptic Processing

Knowledge, Skills, Abilities

  • Independently motivated and can work within a cross-functional team.
  • Must be able to work in a fast-paced environment.
  • A strong attention to detail.
  • 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.

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.

Contact Information
Company Name: Thermo Fisher Scientific
Website: https://thermofisher.contacthr.com/...
Company Description:

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