Principal Researcher, Downstream Process Development - Biologics

Eisai US; Exton (PA); On-site; USD 80,000 - 105,000; Full time

Benefits offered by this job

Employee benefit programs

Annual Incentive Plan

Job summary

Eisai US in Exton, PA, is seeking a Principal Researcher in Downstream Process Development for biologics. You will execute laboratory scale experiments for purification, participate in tech transfers, and support viral clearance studies.

The role requires BS/MS in biological sciences and 5+ years with purification techniques; proficiency with AKTA systems and Unicorn; strong documentation and collaboration.

Qualifications

• BS or MS in biological sciences, chemistry, biochemistry or equivalent is strongly preferred.
• Minimum 5 years' experience with protein purification techniques for biopharmaceuticals.
• CMC protein purification development experience with chromatography and filtration operations.
• Extensive experience with AKTA chromatographic instruments and Unicorn method writing.

Responsibilities

• Design and perform laboratory experiments for early and late-stage biologic drug products.
• Support viral clearance studies and technology transfers.
• Prepare technical reports, presentations and protocols.
• Perform analytical assays like HPLC, electrophoresis and ELISA to support purification development.

Skills

Protein purification

AKTA systems

Unicorn method writing

DoE

Data interpretation

Education

BS or MS in biological sciences/chemistry/biochemistry

Tools

AKTA Avant

AKTApilot

Unicorn

HPLC

Job description

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai’s human health care (hhc) mission. We’re a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on 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. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.

Job Summary

The Principal Researcher of Downstream Development will be responsible for executing laboratory scale experiments for all aspects of protein purification including chromatography, filtration and membrane separations (TFF, UFDF, microfiltration, viral filtration, and depth filtration), investigating and evaluating novel technologies to improve current purification processes, participating in internal/external technology transfers, performing standard analytical methods to characterize biologics and reagents including UV/Vis spectroscopy, HPLC, electrophoresis and ELISA, participate in design, planning and execution of viral clearance studies and planning and execution of process validation experiments in support of late stage products. The individual will also be responsible for maintaining PD equipment and laboratories to ensure efficient, safe and effective operations of the laboratory. The individual might also participate in project sub teams and provide cross-functional support for other departments at the discretion of management.

Essential Functions

• Under minimal supervision, design and performs laboratory Experiments for early and late-stage biologic drug products, support viral clearance studies, support authoring of regulatory documents, maintain critical data in laboratory notebooks, and maintain PD equipment and laboratories to ensure efficient and effective operations of the laboratory
• Under minimal supervision perform scale up and tech transfer of purification processes for internal GMP production and to external partners and CMOs
• Writing, preparation and review of 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 activities
• Order supplies, manage samples, discard expired reagents and perform housekeeping and other laboratory maintenance tasks to assure laboratories are continuously maintained in a safe, orderly and efficient condition
• Interact cross-functionally with Upstream Process Development, Operations, Facilities, R&D, Quality Assurance, Quality Control, Validation, QC Biochemistry, and other internal and external functions to support successful product development

Requirements

• Education: BS or MS in biological sciences, chemistry, biochemistry or equivalent job experience/degree is strongly preferred
• Minimum 5 years' experience with protein purification techniques for biopharmaceuticals
• Must have 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)
• Must have extensive experience with AKTA chromatographic instruments and Unicorn method writing for systems such as AKTA Avant and AKTApilot
• Must have excellent attention to detail and ability to keep detailed written records Able to author clear and concise technical reports and presentations
• Demonstrated ability to independently design, execute, and interpret experimental data to further process/product knowledge
• Experience in Design of Experiments (DoE) and multivariate analysis preferred
• Experience with high throughput screening techniques, including Tecan, preferred
• Knowledge or experience with scale-up, technology transfer, process validation, viral clearance studies, and GMP manufacturing desirable
• Experience with analytical techniques such as HPLC, electrophoresis and ELISA desirable
• Strong written and oral communication skills and good interpersonal skills. Team player who can excel in fast-paced entrepreneurial environment

Physical requirements

handling of laboratory equipment, chemicals and biological materials.

Salary

The annual base salary range for the Principal Researcher, Downstream Process Development - Biologics is from :$80,200-$105,200.

Benefits

• Employees are eligible to participate in Company employee benefit programs.
• Certain other benefits may be available for this position, please discuss any questions with your recruiter.
• Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan.

Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status.

Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.

Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information: Right To Work E-Verify Participation At Eisai Inc., human health care (hhc) is our goal. We give our first thoughts to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we have a passionate commitment to patient care that is the driving force behind our efforts to discover and develop innovative therapies to help address unmet medical needs. Eisai is a fully integrated pharmaceutical business that operates in two global business groups: oncology and neurology (dementia-related diseases and neurodegenerative diseases). Our U.S. headquarters, commercial and clinical development organizations are located in New Jersey; our discovery labs are in Massachusetts and Pennsylvania; and our global demand chain organization resides in Maryland and North Carolina. To learn more about Eisai Inc., please visit us at www.eisai.com/US and follow us on Twitter and LinkedIn. All data that is entered should be in the correct case, please refrain from using all caps. For a better user experience, we recommend using the latest version of Chrome.