Thermo Fisher Scientific Scientist I, Manufacturing Sciences – Central Operations in Canoga Park, California

Job Description

When you join us at Thermo Fisher Scientific, you’ll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Central Operations supports manufacturing process across the Transplant Diagnostics (TDX) business at Thermo Fisher Scientific. This team is responsible for identifying and enabling manufacturing through standardization, process improvement, and reducing the burden of laboratory support activities that are non-essential to critical process operations.

The Scientist I, Manufacturing Services, Central Operations works efficiently and proactively with the highest quality production and brings their individual talents, experience and skills to the Central Operations team so it functions as a single unit. Attention to detail and the ability to follow written instructions to complete assigned tasks are critical to the success of the Central Operations group, as well as clear communication and accountability.

Essential Job Functions:

  • Set up and maintenance of Luminex 200, FlexMAP3D, flow cytometer, and other related instruments

  • Execute IQ/OQ/PQ protocols and generate deviation reports

  • Collaborate with R&D and Operations to perform risk analysis during process transfers

  • Coordination of all aspects of the Central Services provided to manufacturing. Balance multiple tasks

  • Demonstrate knowledge in the use of basic lab techniques and basic computer knowledge

  • Demonstrate the ability to meet standards as defined by the manufacturing process

  • Adjust priorities to meet production deliverables

  • Recommend measures to improve production process methods and equipment performance while keeping quality of product in mind

  • Follow GMP documents (SOPs, MPs) with strict adherence to safety and compliance

  • Perform and monitor critical processes

  • Visual Inspections

  • Complete and review production documents in real time

  • Prepare buffers/media per defined manufacturing procedures (MPs) and standard operating procedures (SOPs)

  • Orders, receives, and stocks reagents, chemicals, and lab supplies to the appropriate departments, while observing appropriate inventory levels.

  • Hands-on operation, set-up, cleaning, and sanitization of bioreactors and various cell culture support vessels

  • Perform in process sampling of cell culture equipment and operate analytical equipment

  • Perform washroom activities; clean equipment, small to large scale, used in production activities

  • Maintain an organized and clean workspace

  • Work in a clean room environment wearing steel toe shoes, full clean room gowning, hairnet and latex gloves when performing all work

  • Initiate quality nonconformance reports (NCRs)

  • Draft and revise documents (SOPs, MPs)

  • Identify, recommend, and implement improvements related to routine functions

  • Assist in the review of documentation for assigned functions (equipment logs, batch records)

  • Maintains areas in high state of inspection preparedness and safety compliance

  • Works effectively and efficiently in a team-oriented environment to keep GMP Manufacturing operations running smoothly

  • Train individual workers in proper procedures and work instructions

  • Utilizes laboratory equipment such as scales, glassware, and pH meters to perform measurements.

  • Monitors temperatures and maintains complete and accurate records of equipment logs

  • Operates and maintains steam autoclaves, keeping records of loads completed, items in loads

  • Other tasks as assigned

Supervisory Responsibility: N/A

Minimum Requirements/Qualifications:

  • Bachelor’s degree required, with majors in Biology, Chemistry, or other similar Life Science field. Knowledge of equipment qualification (IQ/OQ/PQ), process validation, method validation and computer/automation systems.

  • Knowledge of cell culture procedures and microbiological principle of contamination

  • Proficiency to perform pipetting, molarity calculations, and dilution calculations

  • Ability to follow manufacturing procedures (SOPs, PSWIs) and adhere to Good Manufacturing Practices (cGMP), specifically around Good Documentation Practices (GDP) requirements

  • Willingness to participate or lead PPI Business System / Kaizen/ Process Improvement events

  • Maintains a mindset for continuous improvement

  • Ability to work as a cooperative member within diverse teams

  • Always maintain confidentiality of all business and scientific information and data

  • Effectively communicate both verbally and in writing with manager and technicians

  • Working knowledge of computers and basic business software to include Microsoft Office (i.e. Word, Outlook, Excel) Preferred Qualifications:

  • Experience with Lean or Lean Six Sigma

Experience/Skills:

  • Required – Ability to follow manufacturing procedures (SOPs, PSWIs) and adhere to Good Manufacturing Practices (cGMP), specifically around Good Documentation Practices (GDP) requirements.

  • Willingness to participate or lead PPI Business System Kaizen/Improvement Events.

  • Mindset for continuous improvement.

  • Preferred – Lean or Lean Six Sigma exposure.

  • Ability to work as a cooperative member within diverse teams.

  • Ability to maintain confidentiality of all business and scientific information and data.

  • Ability to effectively communicate verbally and in writing with manager and technicians.

  • Ability to sit, stand, and/or walk for long periods of time in a laboratory setting.

  • Computer skills/knowledge - Working knowledge of computers and basic business software.

  • Must be available to work on weekends and nights if needed.

Working Conditions/Physical Requirements:

  • Frequently work at lab bench, low temperature freezers and PC workstations

  • Controlled manufacturing/laboratory environment.

  • Position will require frequent communication, sitting, standing, and/or or walking for prolonged periods of time in and out of designated area where PPE will be required.

  • Ability to lift 35 to 50 pounds.

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not to be construed, as an exhaustive list of all employee responsibilities, duties and/or skills required of all personnel so classified.

This position is not eligible for relocation benefits.

At Thermo Fisher Scientific, each one of our 70,000 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.

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.

If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here at https://jobs.thermofisher.com/page/show/eeo-affirmative-action-statement#accessibility 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 legally protected status.