Cell Therapy Manufacturing, Specialist at Thermo Fisher Scientific in San Francisco, California

Job Description:

Work Schedule

Standard (Mon-Fri)



Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift



Job Description



As part of Thermo Fisher Scientific Inc., you'll have the unique opportunity to contribute to groundbreaking projects that make a tangible difference globally. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.


How will you make an impact?


The specialist in this role will be part of a cohesive team responsible for suite readiness, as well as owning/supporting Quality Documents and Records for all phases of manufacturing. The Specialist uses expert knowledge of cGMP regulations and project management to support manufacturing. The role will support equipment, documentation, training, and improvement initiatives within manufacturing operations.


What will you do?

• Complete cell manufacturing and cell processing activities in open and closed systems, use aseptic techniques during processing to ensure the highest integrity, viability and sterility of cellular product until release, with "right the first time" mind set. Support manufacturing investigations as needed.
  
  


• Conduct document revisions and manage Manufacturing Batch Records, Work Instructions, Job Aids, and Standard Operating Procedures.
  
  


• Perform manufacturing activities in laboratory and clean room environments with lab PPE and specialized sterile gowning.
  
  


• Document all activities to meet GDP requirements and provide feedback for continuous learning.
  
  


• Support cross-functional continuous improvement teams, including Engineering, Validation, QA, QC, Facilities, and Manufacturing Science and Technology.
  
  


• Collaborate with manufacturing leaders and training teams to develop and maintain training programs for manufacturing staff.
  
  


• Enhance compliance with quality procedures, policies, and regulations.
  
  


• Participate in client and planning meetings, including presentations and document preparation.
  
  

Education

• Minimum High School diploma or equivalent experience is required.
  
  


• Associates or higher degree in Biology, Life Science, Engineering preferred.
  
  

Experience

• 2+ years of GMP Manufacturing experience in Life Science or Biopharmaceutical industry required.
  
  


• 1+ year of Cell Therapy processing preferred.
  
  


• Experience using SAP Supply Chain Management system preferred.
  
  


• Strong interpersonal and communication skills, with the ability to work effectively in a diverse community.
  
  


• Ability to make decisions and work with minimal to moderate supervision.
  
  


• Solid understanding of applicable regulatory requirements.
  
  

Knowledge, Skills, Abilities

• Ability to gown aseptically and withstand cleanroom coveralls for 4+ hours at a time.
  
  


• Capability to balance multiple tasks and demonstrate knowledge in basic lab techniques and computer use.
  
  


• Ability to communicate effectively within and between teams, and to act upon feedback.
  
  


• Ability to perform physical labor and lift 20+ lbs,, stand, walk; use hands to finger, handle, or feel; reach with hands and arms; and stoop, kneel, or crouch.
  
  

Compensation and Benefits

The hourly pay range estimated for this position based in California is $29.00-$33.00.


This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs
  
  


• Employee assistance and family support programs, including commuter benefits and tuition reimbursement
  
  


• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
  
  


• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
  
  


• Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
  
  

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards Apply Now