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Thermo Fisher Scientific

Makes lab instruments, reagents and supplies

Analytical Development Scientist - HPLC

Bioprocess & BiomanufacturingConfirmed live in the last 24 hours
Full-timeBedford, MA, USA$92k - $135k

About the Job

Requirements

  • A Ph.D. or M.S. with 3+ years of experience in Analytical Chemistry, Biochemistry, Chemical Engineering, Biotechnology, Pharmaceutical Sciences, or a related scientific field is preferred; a Bachelor's with 5+ years of experience in those fields is acceptable.
  • Hands-on experience with analytical chromatography systems, preferably HPLC or UHPLC.
  • Strong understanding of analytical chromatography principles, method development, method optimization, and data interpretation.
  • Experience developing or applying analytical methods used to characterize biological molecules, biopharmaceutical products, or process-related attributes.
  • Experience designing experiments, analyzing analytical data, troubleshooting methods, and drawing technically sound conclusions.
  • Demonstrated ability to work effectively in cross-functional technical teams.
  • Strong technical writing, documentation, and communication skills.

Responsibilities

  • Develop, optimize, and apply analytical HPLC methods to characterize product performance and support new product development.
  • Design and execute experiments to evaluate product attributes relevant to regulated bioprocessing, biologics development, and drug-quality monitoring.
  • Develop analytical strategies to assess critical-to-quality attributes, including purity, aggregation, charge variants, identity, concentration, or other relevant product and process attributes.
  • Generate, analyze, and interpret complex analytical datasets to guide technical decisions, product requirements, and development strategy.
  • Evaluate HPLC product performance across relevant use conditions, sample types, workflows, and customer applications.
  • Support product development activities, including feasibility studies, prototype evaluation, design verification, process optimization, technology transfer, and commercialization.
  • Collaborate with Product Management, Applications, Manufacturing, Quality, Regulatory, Commercial, and other R&D teams throughout the product lifecycle.
  • Support method transfer, manufacturing validation, and new product introduction activities through experimentation and documentation.
  • Author technical reports, protocols, standard operating procedures, test methods, presentations, and other scientific documentation.
  • Identify technical risks, troubleshoot analytical challenges, and adapt experiments based on emerging data.
  • Contribute to innovation initiatives by identifying new applications, technologies, customer needs, and product opportunities.
  • Present technical findings and recommendations to internal stakeholders and, when appropriate, external customers.

Desired Qualifications

  • Experience in a regulated, GMP-adjacent, quality-control, analytical development, process development, or biopharmaceutical laboratory environment.
  • Familiarity with analytical methods used to monitor critical-to-quality attributes in biologics or bioprocessing workflows.
  • Experience with one or more analytical characterization techniques such as size-exclusion chromatography, ion exchange chromatography, reversed-phase chromatography, hydrophobic interaction chromatography, affinity chromatography, enzyme-linked immunosorbent assay, ion chromatography, dynamic light scattering, ultraviolet-visible spectroscopy, capillary electrophoresis, or mass spectrometry.
  • Familiarity with analytical method lifecycle concepts, including method qualification, validation, transfer, robustness, precision, accuracy, specificity, and system suitability.
  • Knowledge of FDA, ICH, USP, or other regulatory guidance related to drug quality, analytical methods, or biologics characterization.
  • Experience with downstream purification, bioprocessing, biologics development, chromatography media, chromatography columns, or analytical workflow development.
  • Experience supporting technical transfer, manufacturing validation, product launch, or customer-facing technical activities; direct product development experience is not required.
  • Ability to identify issues, troubleshoot experiments, adapt based on data, and seek input when needed.

About the Company

Thermo Fisher Scientific

Makes lab instruments, reagents and supplies

Thermo Fisher Scientific makes and sells the instruments, chemicals, consumables and lab services that drug companies, hospitals, universities and industrial labs use for research, testing and production. Its products cover work from gene sequencing and protein analysis to diagnostic tests and lab freezers, and its distribution arm ships supplies to labs worldwide. Drug developers also hire it to run clinical trials and to manufacture medicines under contract. It earns money from consumables that labs buy again and again, along with instrument sales, service contracts and outsourcing fees. The company traces its roots to Thermo Electron, founded in 1956, which merged with Fisher Scientific in 2006, and it is based in Waltham, Massachusetts.

Company size
10,001+
Company stage
IPO
Headquarters
Waltham, MA
Founded
1956

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