Director, Analytical Outsourcing & Stability, Biologics Biopharmaceutical Development
Eisai US
Summary
Director, Analytical Outsourcing & Stability will oversee product release and stability testing at sites in the US and internationally. This position will also serve as a scientific and technical resource to support several early to late-stage manufacturing programs.
Job description
This position will be responsible for the review and interpretation of analytical testing data as well as protocols and reports, with an emphasis on scientific validity and adherence to FDA, EMEA, ICH and JP guidelines. This position will also spend a significant amount of their time troubleshooting assays, designing future studies, overseeing assay validation and interacting with QA to determine product stability and shelf life. Since these programs are for products from pre-IND through phase 3, knowledge of the regulatory requirements at each stage of clinical development is essential.
This position will have a direct impact on the success of the company by managing the analytical testing for several products, as well as interfacing with internal and external clients, suppliers and contractors. This position will ensure that these projects remain on schedule and within budget, as well as identify major milestones and critical steps needed for the success of the projects and the development programs they support. This position will be responsible for communicating with team members and management about progress, potential impediments and solutions.
Essential Functions
- Managing external testing lab collaborations
- Review and interpretation of analytical data
- Troubleshooting of analytical assays and design of future studies
- Managing assay tech transfer to CMO
- Managing assay validation activities at CMO
- Review testing protocols and reports
- Interact with other departments within Exton
- Tracking finances and accounting
Requirements
- Graduate level degree in biological sciences or related subject required; Ph.D. highly preferred
- Minimum of 8 years of relevant analytical experience with biologics development, several of which must be in a management position
- Strong knowledge of biologics manufacturing and analytical methodology
- Knowledge of ICH, cGMP, EMEA and JP guidelines as they pertain to development/manufacturing of monoclonal antibody-based, ADC, bispecific and fusion protein-based therapies
- Prior contract manufacturing project management experience highly preferred
- Prior experience with biologics development from pre-IND through phase 3 or commercial production highly desired
- Understanding of project accounting and financial concepts required
- Hands-on, proactive stance with willingness and ability to assist all team members
- Excellent interpersonal skills mandatory
- Analytical problem solving, ability to set priorities and achieve goals
- Strategic thinking, energy, enthusiasm and entrepreneurial mindset
- Ability and willingness to travel (domestic and international) approximately 20% of the time required
Benefits
- Annual Incentive Plan
- Long Term Incentive Plan
- Company employee benefit programs
Company overview
Eisai US is the American pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., a global pharmaceutical company founded in 1941. Headquartered in Nutley, New Jersey, Eisai US operates with a passionate commitment to patient care through its human health care (hhc) philosophy, which places patients and their families at the forefront of all business decisions. The company focuses on two primary therapeutic areas: oncology and neurology, with particular emphasis on dementia-related diseases and neurodegenerative disorders. Eisai US maintains a fully integrated pharmaceutical business model with end-to-end capabilities spanning discovery, development, and marketing. The organization operates commercial and clinical development organizations in New Jersey, discovery labs in Massachusetts and Pennsylvania, and global demand chain operations in Maryland and North Carolina. Notable products in its portfolio include Leqembi (lecanemab) for Alzheimer's disease, Lenvima (lenvatinib) for various cancers, and Aricept (donepezil) for Alzheimer's treatment. With approximately 1,001-5,000 employees in the United States, Eisai US represents a significant presence in the American pharmaceutical landscape, dedicated to addressing unmet medical needs through innovative therapies and comprehensive patient support programs.