Research/Senior Research Investigator - Biologicals Analytical Development

General Summary:

Eisai's corporate philosophy focuses on meeting the diverse needs of patients and their families and increasing the benefits that health care provides. We express this philosophy with the phrase "human health care," and continue to concentrate efforts on its realization worldwide. Throughout the company's 68 years of operation, drug discovery has been an integral part of its mission to advance human health care for patients and their families, as well as a major contributor to Eisai's success. Today, Eisai is Japan's third largest pharmaceutical company, ranking in the top 25 worldwide. Eisai's global R & D efforts are focused in several therapeutic areas, including central nervous system, oncology, gastrointestinal, and inflammatory diseases. Eisai in Andover, MA, is the center for product creation in the U.S., with an emphasis on finding new treatments for immune disorders and cancer.

Primary responsibilities, specific duties:

We are seeking an individual to contribute to the success of our Pharmaceutical Science and Technology unit.  The candidate will identify, develop, and implement new cell biology and analytical test methods for raw materials, drug substances and products for macromolecular and other products to support manufacturing process development, pre-clinical studies, and early phase clinical trials.  In addition, the candidate will oversee cell-based method development, validation, and testing activities at analytical CROs. 

Critical Performance Areas:

1. Develop, optimize, and qualify flow cytometry, ELISA, binding, cell based, and potency assays.
2. Perform analytical testing of drug substances, drug products, and in-process samples and raw materials with an emphasis on cell-based bioassays.
3. Oversee method transfer, development, and validation activities at CROs.
4. Prepare and review analytical data packages and testing summary reports.
5. Report OOS data and contribute to investigations and problem solving.
6. Support in-house stability studies and direct those carried out by CROs.

Duties and Responsibilities:

• Qualify, optimize, and execute cell-based activity, binding, and potency assays.
• Conduct early-phase routine drug substance and drug product release and stability testing.
• Perform testing to support manufacturing process development and preclinical studies.
• Develop, optimize, and qualify appropriate cell banking SOPs.
• Comply with cGMP, GLP, ISO Quality Assurance Procedures, Protocols, SOPs and established guidelines.
• Participate in analytical method qualifications and transfers.
• Report OOS data to appropriate management pertaining to in-process, finished product, and stability. Contribute to investigations and problem solving.
• Perform/assist in instrument calibration and/or maintenance.
• Maintain controlled storage temperature recorders.
• Prepare and review analytical data packages and testing summary reports.
• Support and contribute to general laboratory operations, documentation, and quality improvements.
• Perform other projects and responsibilities as assigned.

Job Qualifications:

• M.S. in cellular biology, immunology, or relevant field required, PhD preferred.
• 0-5 years if Ph.D. or 5-8 years if M.S. in the pharmaceutical industry working with cell-based assays and methods development.
• Demonstrated expertise in flow cytometry, bioassay development, ELISA, PCR, and tissue culture.
• Demonstrated excellence in analytical thinking, experimental design, problem solving, and report writing.
• General knowledge of FDA regulations, global regulations, ICH guidelines, and GLP/GMP requirements.
• Knowledge of biocomparability requirements.
• Strong oral and written communication skills.
• Critical thinking skills with ability to identify issues requiring further attention.
• Self-starter with ability to work equally well independently or with colleagues.
• Effective planning and organizational skills.
• Dedicated and team-oriented individual.

For more information and other job postings, please visit the Eisai web site at: www.eisai.com
Eisai conducts background checks and pre-employment physicals
We are an equal opportunity employer M/F/D/V