Scientist – Stability Data Review

Thermo Fisher Scientific•Boston, MA

1d•Onsite

About The Position

FSP - Scientist – Stability Data Review is a full-time, Monday – Friday, 8am-5pm EST role that is fully onsite at our customer’s site in Boston, MA. This role is with Thermo Fisher Scientific's clinical research business, a leading global contract research organization. The Laboratories Functional Service Partnership (FSP) team plays a direct role in advancing drug development by creating sustained groups of talent within our customers’ organizations to provide long-term support. Through this collaborative approach, our professionals bring their commitment to excellence, industry knowledge, and operational strength directly into customer environments, helping to enhance capabilities and advance the delivery of life-changing therapies.

Requirements

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.
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.
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Able to work upright and stationary and/or standing for typical working hours.
Able to lift and move objects up to 25 pounds
Able to work in non-traditional work environments.
Able to use and learn standard office equipment and technology with proficiency.
May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
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.

Nice To Haves

Knowledge of biologics assays including protein concentration, potency, ELISA, SE-UPLC, CE-SDS, icIEF, qPCR are a plus

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

Benefits

Competitive remuneration
Annual incentive plan bonus
Healthcare
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
Short- and long-term disability
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