Thermo Fisher Scientific · 7 hours ago
Scientist - Stability Data Review
Boston, MA
Full-time
Onsite
Entry, Mid Level
$35/hr - $45/hr
2+ years expThermo Fisher Scientific is a leading global contract research organization dedicated to enabling customers to make the world healthier, cleaner, and safer. They are seeking a Scientist for Stability Data Review who will be responsible for the technical review and reporting of commercial stability programs, ensuring compliance with cGMP standards, and generating stability reports for regulatory submission.
Research
No H1B
Responsibilities
Technical review and reporting of commercial stability programs
Review of technical and compliant cGMP analytical data, with focus on biologic assay
Perform data analysis and trending according to industry guidelines
Generate and provide stability reports for submission to regulatory authorities
Authors and/or reviews trending reports
Effectively communicate with internal and external stakeholders
Ensure all records adhere to cGMP/GDP expectations
Qualification
Required
Must be legally authorized to work in the United States without sponsorship
Must be able to pass a comprehensive background check, which includes a drug screening
Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar
Scientist: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years') OR Masters degree
Experience with commercial stability programs
Experience with statistical software and its application to support commercial stability
Knowledge of US and EU cGMP regulations/guidance
Knowledge of biologics assays including protein concentration, potency, ELISA, SE-UPLC, CE-SDS, icIEF, qPCR are a plus
Ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and attention to detail
Effective communication skills, both verbal and written
Benefits
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
Company
Thermo Fisher Scientific
The world leader in serving science To serve science, Thermo Fisher Scientific needs to stay ahead of it, we need to anticipate customer needs.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Heather Stewart
HR Business Partner - Global Enterprise Services
Laura Green
Associate Human Resources Business Partner
Company data provided by crunchbase