Senior Scientist - SEC / iCIEF / Impurity

ThermoFisher Scientific; Boston (MA); On-site; USD 95,000 - 100,000; Full time

Benefits offered by this job

Medical plans

Vision plan

Paid time off (PTO) 120 hours+

401(k) plan with company match

EspP stock purchase

Job summary

Thermo Fisher Scientific in Massachusetts seeks a Senior Scientist for SEC/icIEF/Impurity work to lead analytical methods development and transfer in a GMP setting. The role is fully onsite in Boston, with standard day shifts and responsibilities across method validation, lifecycle management, and regulatory support.

The ideal candidate will hold a Bachelor's or higher in a lab science, 2–4+ years of relevant experience, strong writing and collaboration skills, and the ability to operate within

Qualifications

• Experience in analytical method development, validation, transfer and lifecycle management for biologics or related products.
• Strong knowledge of GMP requirements and regulatory guidance for late-stage and commercial products.
• Excellent scientific writing and data interpretation abilities; ability to compile regulatory documentation.

Responsibilities

• Support technical transfer, validation, remediation and impurity assays for biologics (LC, SEC, icIEF, CE-SDS).
• Author, review and approve technical protocols, reports and lifecycle documents.
• Develop transfer study designs, testing plans and acceptance criteria.
• Manage critical reagents, reference standards and supply continuity.
• Support investigations, CAPAs, OOS/OOT and risk assessments.
• Provide analytical content for regulatory submissions and inspection readiness.

Skills

Method development

Transfer

Regulatory knowledge

Data analysis

Technical writing

Education

Bachelor's degree in lab sciences

Sr. Scientist experience (4+ years)

Masters degree (2+ years)

PhD

Tools

JMP

Job description

Work Schedule

First Shift (Days)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting

Job Description

FSP - Senior Scientist - SEC / iCIEF / Impurity

Shift: Full-Time; Monday – Friday; 8am-5pm EST

ONSITE:

This is a fully onsite role based at our customer’s site in (Boston, MA). We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate.

Must be legally authorized to work in the United States withoutsponsorship.

Must be able to pass a comprehensive background check, whichincludes a drug screening.

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life‑changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission – to enable our customers to make the world healthier, safer, and cleaner.

Our 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.

Key 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.

• Manage planning and 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.

Education and Experience:

• Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar

• Sr. Scientist: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4+ years’)

• OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’)

• OR PhD

In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

• 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 with analytical data review, trending, comparability assessment, and statistical tools such as JMP is preferred.

• Familiarity with reference material qualification, stability and requalification, inventory management, and method specific system configuration is preferred.

• 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.

Working Environment:

Below is listed the working environment/requirements for this role:

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.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward‑thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Compensation and Benefits

The salary range estimated for this position based in Massachusetts is $95,000.00–$100,100.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• 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

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.