Position Description/Summary

Responsible for cGMP manufacturing upstream operations at the Thermo Fisher Scientific Lexington site.

Responsibilities include:

• Performing basic to complex activities in seed train, bioreactor, clarification and hTFF.
• Executing aseptic operations within Biosafety cabinet and cleanroom environment.
• Performing pipetting, pouring, seeding and harvesting of adherent cell lines using tissue flasks and cell stacks.
• Preparation of growth and production media.
• Performing critical upstream activities utilizing iCELLis bioreactor platform.
• 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, sanitization and disinfection.
• Demonstrates ability to troubleshoot basic mechanical operations.
• Conducts training for less experienced personnel
• Work in accordance with site and company EHS programs.
• Work in accordance with regulations, detailed protocols, Batch Record’s, SOP’s and Work Instructions.

  Work Hours:

• The incumbent will onboard and support project activities Monday through Friday, 8:00 AM to 5:00 PM. The position will transition to 7:00 PM to 7:00 AM 12-hour day time rotation as the site becomes operational.
• May require overtime to work evenings, weekends or holidays, as required to meet project timelines.

  Requirements:

• 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.

  Knowledge, Skill and Requirements

  Minimum Qualifications:

• Bachelor’s Degree with 1-3 years of industry related experience in cGMP manufacturing.
• High School diploma and 2-4 years’ industry related experience in cGMP manufacturing.
• Independently motivated and can work within a cross-functional team

  Preferred Qualifications:

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

  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.