Raw Material Scientist II

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life 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 worlds toughest challenges like protecting the environment making sure our food is safe or helping find cures for cancer.

Position Objective
Join our team as a Raw Material Scientist II where youll be responsible for ensuring the quality suitability and compliance of raw materials used in cell culture media manufacturing. This role supports supplier qualification incoming material evaluation and continuous improvement initiatives to ensure robust material quality and reliable manufacturing operations.

How will you make an impact

• Evaluate documentation from cell culture media raw material suppliers and approve them for use.
• Assess raw materials against compendial requirements and other relevant standards.
• Define and advise on QC testing requirements and evaluate Incoming Quality Control test data results from both internal and external test laboratories.
• Develop assays for use in testing and evaluation of components to ensure material quality.
• Apply scientific knowledge to drive raw material PRs testing issues OOS and investigations.
• Develop and maintain raw material specifications when required.
• Engage in Practical Process Improvement teams to sustain a culture of operational excellence continuous improvement and productivity.
• Performs statistical analysis to analyze trends and works with cross-functional teams to investigate conduct root cause analysis and recommend corrective actions for processes.
• Support the site change control system including process risk assessment in the form of FMEA tools.
• May require occasional weekend/off-hours support

Required Education and Experience:

• Minimum of Bachelors Degree in Chemistry Biochemistry Chemical Engineering Biotechnology Molecular Biology or related scientific field with
• 2 years of experience in GMP manufacturing a laboratory-based role supporting GMP manufacturing raw material qualification process development or a related technical role.
• Must be able to wear required PPE and work in controlled environments
  Demonstrated problem-solving and troubleshooting capabilities
• Ability to work independently and collaboratively in a dynamic environment

Preferred Qualifications:

• Strong understanding of cGMP requirements regulatory compliance and quality systems
• Expertise in analytical techniques and laboratory instrumentation (HPLC spectroscopy etc.)

• Experience with process validation technology transfer and scale-up activities
• Proficiency in aseptic techniques and cleanroom operations
• Strong project management and documentation skills
• Excellent written and verbal communication abilities
• Proficient with Microsoft Office Suite and relevant manufacturing/quality systems
• Experience with risk assessment and root cause analysis
• Physical requirements include ability to lift up to 35 lbs and stand for extended periods
  

What We Offer

Competitive Salary:

• Pay rate based on experience
• Annual performance-based bonus
• Annual merit performance-based increase

Excellent Benefits!

• Medical Dental & Vision benefits-effective Day 1
• Paid Time Off (120 hours per year) Designated Paid Holidays
• 401K Company Match up to 6%
• Tuition Reimbursement eligible after 90 days!
• Employee Referral Bonus

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 team of 100000 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.

Compensation and Benefits

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: Experience:

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