Impurity

Thermo Fisher Scientific•Boston, MA

9d•Onsite

About The Position

Thermo Fisher Scientific is hiring a Senior Scientist for its Laboratories Functional Service Partnership (FSP) team. The role provides long-term analytical support within a customer organization, helping advance biologics and cell and gene therapy development. The scientist supports technical transfer, implementation, validation, remediation, and lifecycle activities for biologics separation methods and related impurity assays. The role is fully onsite at a customer site in Boston, Massachusetts, Monday through Friday, 8 a.m. to 5 p.m. EST. Relocation assistance is not provided. Candidates must be legally authorized to work in the United States without sponsorship and pass a background check that includes drug screening. The position includes independent technical documentation work, transfer study design, analytical materials planning, laboratory quality-system support, and preparation of analytical content for regulatory and inspection needs. The successful candidate will work across matrixed teams and balance scientific rigor, compliance, timelines, and business risk. A bachelor's degree in a relevant laboratory science and comparable experience is listed as a qualification; alternative experience pathways include a master's degree with comparable experience or a Ph.D. An equivalent combination of education, training, and directly related experience may also be considered. The stated salary range is $95,000–$100,100, with potential eligibility for a variable annual bonus. Benefits include medical, dental, and vision plans; health incentives; employee assistance and family support programs; commuter benefits; tuition reimbursement; paid time off and holidays; paid parental leave; insurance and disability coverage; retirement savings; and an employee stock purchase plan.

Requirements

Bachelor's degree in a laboratory science such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology, or a similar field; equivalent combinations of appropriate education, training, and directly related experience may be considered.
For the bachelor's-degree pathway, comparable experience of 4 or more years; alternatively, a master's degree and comparable experience of 2 or more years, or a Ph.D.
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, timeline, and business risk.
Must be legally authorized to work in the United States without sponsorship and 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 technical protocols, reports, assessments, procedures, and lifecycle documentation within delegated authority.
Develop transfer study designs, testing plans, acceptance criteria, and data-evaluation approaches based on method performance, product knowledge, and receiving-laboratory capabilities.
Plan and manage 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 analytical content and source-document support for regulatory submissions, health authority responses, inspection readiness, and lifecycle commitments.

Benefits

Competitive remuneration and potential eligibility for a variable annual incentive bonus.
Choice of national medical and dental plans and a national vision plan, including health incentive programs.
Employee assistance and family support programs.
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.
Competitive 401(k) U.S. retirement savings plan.
Employee Stock Purchase Plan offering eligible colleagues the opportunity to purchase company stock at a discount.
Career and development prospects.