Senior Scientist - SEC / iCIEF / Impurity

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 without sponsorship.

Must be able to pass a comprehensive background check, which includes 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.

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