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Thermo Fisher Scientific Senior Manufacturing Associate, Downstream Nights in Lexington, Massachusetts

Location: Lexington MA

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

How will you make an impact?

This position requires following defined procedures to perform basic to complex operations on the Downstream manufacturing process within a cGMP cleanroom commensurate with the individual's level of technical expertise, training, and qualification.

Responsibilities include performing basic bioprocess manufacturing activities and operating bioprocessing equipment, meticulous documentation of performance, monitoring of processing equipment, processes, and control systems within a GMP cleanroom.

The Sr Manufacturing Associate is expected to Fulfill the role of Team Lead in the absence of the team supervisor. Responsible for assignment of duties to all team members, ensuring execution of duties, communicating at daily scheduling meetings, and providing technical support as needed.

The Sr Manufacturing Associate will ensure that the GMP cleanrooms are in a constant state of inspection readiness and perform routine tasks such as cleaning, waste management, equipment maintenance, materials movement and other duties as assigned to assure the cleanroom and manufacturing systems are clean and inspection-ready at-all-times.

The Sr Manufacturing Associate will adhere to all Safety and Quality standards of the organization contribute to continuous improvement in the areas of Safety, Quality, and Delivery.

What will you do?

Responsibilities

  • Executing aseptic operations within Biosafety cabinet and cleanroom environment.

  • Preparation of buffers to support downstream purification activities.

  • Performing critical downstream activities through Chromatography, TFF, Viral Filtration, and Final Formulation.

  • Follows and demonstrates Good Documentation Practices (GDP's).

  • Follows standard operating procedures and work instructions.

  • Identifies, escalates and documents events and variances that deviate from normal operation; participate as needed in investigations.

  • Monitor processes using automated production systems and controls with limited supervision.

  • Equipment preparation, sanitation 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.

  • Fulfills role of lead trainer on numerous operations and is an area SME.

How will you get here?

Required

  • Bachelor's degree with 4-6 years of industry related experience on-the-floor leadership or "subject matter expertise" in cGMP manufacturing.

  • High School diploma and 5-7 years' industry related experience of on-the-floor leadership or "subject matter expertise" in assigned area's core operations. Independently motivated and can work within a cross-functional team

  • Solid understanding of aseptic principles.

  • cGMP Manufacturing experience preferred

  • Cleanroom experience preferred

  • Experience using SAP preferred

  • Buffer or media preparation experience preferred

Knowledge, Skills, Abilities

  • Effectively utilizes Microsoft office applications.

  • Must be able to work in a fast-paced environment.

  • A strong attention to detail through a 12-hour shift.

  • Work towards solutions to given problems and operate under cGMP requirements.

  • Work cross-functionally with support groups such as Facilities, Engineering, Contamination Control, MST, 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.

Work Hours: The position is a 12-hour nighttime rotation after on-boarding is complete.

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 .

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

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