Senior Scientist - SEC / iCIEF / Impurity

Thermo Fisher Scientific • Boston, MA

11d • $95,000 - $100,100 • Onsite

About The Position

The Senior Scientist will support Thermo Fisher Scientific’s Laboratories Functional Service Partnership team at a customer site in Boston, Massachusetts. This fully onsite role provides long-term analytical support within a customer organization to advance drug development and the delivery of therapies. The role focuses on biologics separation methods and related analytical activities, including method transfer, implementation, validation, remediation, troubleshooting, and lifecycle management.

The scientist will independently prepare and, within delegated authority, review and approve technical protocols, reports, assessments, procedures, and lifecycle documentation. The role also involves designing transfer studies and testing plans, coordinating critical analytical materials and reagents, supporting laboratory quality-system investigations and controls, and providing analytical documentation for regulatory submissions and inspections.

The work is performed in a laboratory setting under GMP safety standards. The schedule is Monday through Friday, 8 a.m.–5 p.m. EST. Applicants must be authorized to work in the United States without sponsorship and pass a background check that includes drug screening. Relocation assistance is not provided.

Requirements

• Bachelor’s degree in a laboratory science such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology, or a similar field.
• For the Senior Scientist level, comparable experience of 4 or more years with a bachelor’s degree, 2 or more years with a master’s degree, or a PhD; an equivalent combination of appropriate education, training, and directly related experience may be considered.
• Strong practical experience in analytical method development, validation, transfer, lifecycle management, and troubleshooting for biologics and/or cell and gene therapy products.
• Working expertise with relevant analytical technologies, such as HPLC/UPLC, capillary electrophoresis, icIEF, SEC, peptide mapping, protein concentration methods including SoloVPE, and product- or process-related impurity methods.
• Solid knowledge of current Good Manufacturing Practice requirements and analytical expectations under ICH, USP, Ph. Eur., JP, and applicable FDA guidance for late-stage and commercial products.
• Experience working within quality systems and electronic document platforms supporting change control, deviations, CAPA, controlled procedures, and technical records.
• Strong technical writing, communication, collaboration, and influencing skills, with the ability to work effectively in a matrixed environment.
• Ability to operate independently on defined workstreams, recognize when escalation is needed, and balance scientific rigor, compliance, timelines, and business risk.
• Must be legally authorized to work in the United States without sponsorship.
• Must be able to pass a comprehensive background check, including drug screening.

Nice To Haves

• Experience with analytical data review, trending, comparability assessment, and statistical tools such as JMP.
• Familiarity with reference material qualification, stability and requalification, inventory management, and method-specific system configuration.

Responsibilities

• Support technical transfer, implementation, validation, remediation, and lifecycle activities for biologics separation methods, including LC, SEC, P188, icIEF, CE-SDS, peptide mapping, and impurity assays.
• Independently author, review, and approve, within delegated authority, technical protocols and reports, technical assessments, procedures, and related lifecycle documentation.
• Develop transfer study designs, testing plans, acceptance criteria, and data-evaluation approaches based on method performance, product knowledge, and receiving-laboratory capabilities.
• Plan and coordinate shipment of critical analytical reagents and materials, including reference standards, system suitability controls, columns, kits, and method-specific reagents; maintain shipment documentation, inventory visibility, receipt confirmation, and continuity of supply.
• Support laboratory investigations, deviations, CAPAs, OOS/OOT assessments, change controls, impact assessments, risk assessments, and method performance trending.
• Provide accurate analytical content and source-document support for regulatory submissions, health authority responses, inspection readiness, and lifecycle commitments.

Benefits

• Competitive remuneration and eligibility for a variable annual incentive plan bonus based on company, team, and/or individual performance.
• 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 of paid time off and 10 paid holidays annually.
• Paid parental leave, including 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.
• 401(k) U.S. retirement savings plan.
• Employees’ Stock Purchase Plan offering eligible colleagues the opportunity to purchase company stock at a discount.
• Career and development prospects.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior