Scientist 2 (LC/CE)

Fujifilm•Research Triangle Park, NC

1d•Onsite

About The Position

The Scientist 2 will work in the Analytical Development Lab to develop, optimize, and transfer analytical methods for protein-based therapeutics. Methods include Capillary Electrophoresis (CE-SDS and icIEF), U/HPLC, and basic physiochemical methods such as IEX, RP, SEC, Affinity, and HIC. The role serves as a subject matter expert in Empower, CE, or H/UPLC and supports analytical development, characterization, release testing, and technology transfers. The position involves supporting method qualifications, transfers, validations, and process development; designing, executing, and interpreting analytical studies; analyzing complex datasets and communicating conclusions; and authoring technical documentation. The Scientist collaborates with Analytical Development, Process Development, Manufacturing, and Quality teams, contributes to or leads analytical workstreams, and develops and maintains Empower reports, processing methods, and custom fields. The role is onsite in the Morrisville/Research Triangle Park, North Carolina area. The work takes place indoors in temperature-controlled environments. Some areas may be noisy and require earplugs. The role may involve exposure to proteins, caustic agents, reagents, biohazardous products, possible needle sticks, pungent odors, irritants, or aerosols. Physical activities include typing, standing, crouching, reaching, lifting, and moving around designated areas. Occasional lifting of up to 50 pounds, frequent exertion of up to 20 pounds of force, and constant exertion of up to 10 pounds of force may be required. Visual acuity is needed for data analysis, computer use, extensive reading, and use of measurement devices.

Requirements

Master's degree in a relevant scientific discipline and at least 3 years of relevant experience, or a bachelor's degree in a relevant scientific discipline and at least 7 years of relevant experience.
Relevant experience developing and/or transferring analytical methods for protein-based therapeutics using CE, U/HPLC, or basic physiochemical methods.

Nice To Haves

Experience with analytical method qualification, transfer, and validation.
Experience supporting method transfer into Quality Control laboratories.
Familiarity with regulatory expectations for analytical method lifecycle management.

Responsibilities

Develop, optimize, and transfer analytical methods for characterization and release testing of protein therapeutics using U/HPLC, CE, and standard physiochemical methods.
Support method qualifications, transfers, validations, and process development.
Design, execute, and interpret analytical studies supporting development programs and technology transfers.
Analyze complex datasets and communicate scientifically sound conclusions to project teams and stakeholders.
Author technical documentation, including protocols, reports, and laboratory records.
Collaborate with Analytical Development, Process Development, Manufacturing, and Quality colleagues to support project success.
Contribute to or lead analytical workstreams and support multiple projects in a fast-paced development environment.
Develop and maintain Empower reports, processing methods, and custom fields for analytical workflows.
Serve as a technical expert in CE, U/HPLC, or Empower custom fields.
Develop and transfer Capillary Electrophoresis methods, including CE-SDS and icIEF, and U/HPLC methods such as IEX, RP, SEC, Affinity, and HIC for protein-based therapeutics.