Raw Material Scientist II

Thermo Fisher Scientific•Grand Island, NY

4d•$65,000 - $77,000•Onsite

About The Position

Join our team as a Raw Material Scientist II, where you'll 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.

Requirements

Minimum of Bachelor's 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

Nice To Haves

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

Responsibilities

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

Benefits

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
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