Principal Researcher, Downstream Process Development - Biologics

About the Role

At Eisai, we are dedicated to satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers through our human health care (hhc) mission. As a growing pharmaceutical company with breakthroughs in neurology and oncology, we emphasize research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer’s disease. We seek highly-motivated individuals to join our fast-paced environment and make a meaningful impact.

Responsibilities

• Design and perform laboratory experiments for early and late-stage biologic drug products, including protein purification processes such as chromatography, filtration, and membrane separations (TFF, UFDF, microfiltration, viral filtration, and depth filtration).
• Investigate and evaluate novel technologies to improve current purification processes.
• Participate in internal and external technology transfers.
• Perform standard analytical methods to characterize biologics and reagents, including UV/Vis spectroscopy, HPLC, electrophoresis, and ELISA.
• Participate in the design, planning, and execution of viral clearance studies and process validation experiments in support of late-stage products.
• Maintain PD equipment and laboratories to ensure efficient, safe, and effective operations.
• Perform scale-up and tech transfer of purification processes for internal GMP production and external partners/CMOs.
• Write, prepare, and review technical reports, presentations, and protocols.
• Perform characterization assays such as concentration measurements, HPLC SEC, capillary electrophoresis, and ELISA to support purification process development and reagent preparation.
• Order supplies, manage samples, discard expired reagents, and perform housekeeping and laboratory maintenance tasks.
• Interact cross-functionally with Upstream Process Development, Operations, Facilities, R&D, Quality Assurance, Quality Control, Validation, QC Biochemistry, and other internal/external functions.
• Provide cross-functional support for other departments at the discretion of management.

Requirements

• BS or MS in biological sciences, chemistry, biochemistry, or equivalent job experience/degree is strongly preferred.
• Minimum 5 years of experience with protein purification techniques for biopharmaceuticals.
• CMC protein purification development experience with standard bioprocess unit operations such as chromatography separations (resin/membrane: affinity, CEX, AEX, HIC, MM) and filtration operations (depth filtration, virus filtration, sterile filtration, TFF).
• Extensive experience with AKTA chromatographic instruments and Unicorn method writing (for systems such as AKTA Avant and AKTApilot).
• Excellent attention to detail and ability to keep detailed written records.
• Ability to author clear and concise technical reports and presentations.
• Demonstrated ability to independently design, execute, and interpret experimental data to further process/product knowledge.

Preferred Qualifications

• Experience in Design of Experiments (DoE) and multivariate analysis.
• Experience with high throughput screening techniques, including Tecan.
• Knowledge or experience with scale-up, technology transfer, process validation, viral clearance studies, and GMP manufacturing.
• Experience with analytical techniques such as HPLC, electrophoresis, and ELISA.

Skills

• Strong written and oral communication skills.
• Good interpersonal skills.
• Team player who can excel in a fast-paced entrepreneurial environment.

Physical Requirements

Handling of laboratory equipment, chemicals, and biological materials.

Pay

The annual base salary range for the Principal Researcher, Downstream Process Development - Biologics is $80,200 - $105,200. Under current guidelines, this position is eligible to participate in the Eisai Inc. Annual Incentive Plan. Final pay determinations will depend on various factors including experience level, education, knowledge, and skills.

Benefits

Employees are eligible to participate in Company employee benefit programs. For additional information on benefits, visit Eisai Careers Compensation and Benefits. Certain other benefits may be available for this position.