Job Title: QC Scientist I – Cell Therapy

Requisition ID: 226669BR

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to live every single day to enable our customers to make the world healthier, cleaner, and safer. 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 Cell Therapy role will performance tasks in support of the manufacture of Clinical Cell Therapy Manufacturing process. They will be responsible for following Current Good Manufacturing Practices (cGMPs) and carrying out a variety of functions related to the testing including management of environmental monitoring samples and execution of analytical testing on in process, release, and stability samples,. These functions may include but are not limited to activities such as Flow Cytometry, ELISA, review of data generated reports, authoring protocols in accordance to industry standards, site SOPs and policies.

What will you do?

• Assist in all Department functions, such as ordering supplies, equipment, logbooks and data in accordance with site SOPs and policies.
• Documentation of all activities to meet cGMP requirements. Complete document reviews and revisions. Daily record review, tasks, and databases. Actively provide feedback.
• Interpret data results in accordance to concepts of microbiology, industry standards, and site SOPs and policies.
• Critical evaluation of processes, including foresight and thinking ahead.
• Complete preventative maintenance and work notifications tasks on time. Perform equipment testing and routine trouble-shooting.
• Ensure tasks are implemented with a method of prioritization - interpret production schedules and complete tasks accordingly.
• Identify deviations and aid in investigations/root cause analysis. Work to complete documentation of deviations and events in appropriate systems
• Participate in shift exchanges, 1-1’s, department meetings, attend meetings vital to facilitate area needs based on changes, etc.

How will you get here?

Education

• Bachelor’s degree in microbiology, biology, and/or chemistry preferred

Experience

• 3+ years within a GMP QC laboratory
• Direct experience of 2+ years within testing laboratory supporting cell therapy manufacture, cell culture, or facilities/utilities in a GMP pharmaceutical or biopharmaceutical environment is helpful.
• Knowledge, Skills, Abilities
• Extensive knowledge of general and specific QC analytical testing principles, as applicable to focus of position (e.g., raw materials, chemistry, microbiology, etc.).
• Knowledge of cGMP practices, aseptic techniques, and analytical concepts
• Knowledge of industry standards such as ISO, ICH, FDA and USP preferred
• Detail oriented - results driven
• Investigation and experience with Root Cause analysis, preferred
• Able to work independently and as part of a team
• Ability to build, use and interpret scientific tables, charts, and graphs.
• Knowledge of testing and associated equipment protocols and requirements and analytical/microbiological testing instrumentation.
• Familiarity with Cell Therapy Testing methodology such as Flow Cytometry, ELISA testing, Gram Stain, etc.
• Strong interpersonal and communications skills; written and oral.
• Participate and provide input on timelines, potential compliance issues and other related QC activities.
• Able to read, comprehend, and make appropriate alterations to documents such as batch records, quality agreements, SOPs, etc.
• Ability to function in a constantly evolving environment and balance multiple priorities simultaneously
• Proficiency with personal computers, business software (e.g., MS Office) and technical software (e.g., Quality Management System (QMS) software), including software programs generating reports and statistics.

Our Mission is to enable our customers to make the world healthier, cleaner, and safer. Watch as our colleagues explain 5 reasons to work with us. As one global team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.

The salary range estimated for this position is $54,100 - $82,750. This position will also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. Actual compensation will be confirmed in writing at the time of offer.

We offer a comprehensive Total Rewards package that our US colleagues and their families can count on, which generally includes:

• A choice of national medical and dental plans, and a national vision plan
• A wellness program, and valuable health incentive opportunities for company contributions to a Health Reimbursement Account (HRA) or Health Savings Account (HSA)
• Tax-advantaged savings and spending accounts and commuter benefits
• Employee assistance program
• 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, short- and long-term disability, and volunteer time off 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