Senior Director Biologics Analytical Technologies

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.

The Senior Director of Biologics Analytical Technologies (BAT) leads groups of scientists engaged in GxP (QC Biochemistry, Stability, Analytical Outsourcing) and non-GxP (Analytical Development) activities supporting the development, optimization, and characterization of analytical methods used for release and stability of biologic materials for use in Preclinical through Phase III clinical development at the Biologics Pilot Plant as well as through Phase III/licensure by management of technology transfer to external CMOs/CROs/CLOs and partners. The Senior Director ensures phase-appropriate assay development requirements as programs progress through the stages of biologics drug development with a line of site towards development of assays which will be robust, reproducible and capable of being qualified and validated for GMP use, for commercial products.

The Sr. Director maintains a broad knowledge of established and emerging technologies, utilizes internal and external networks, and leverages extensive prior relevant experience to create an effective and efficient organization that is recognized for successfully bringing outstanding analytical science to bear on advancing Eisai's biopharmaceutical programs. The Sr. Director additionally contributes as part of a broader leadership team (BPD, PST), assisting with Biopharmaceutical Development program review and assessment, as well as helping to set and achieve site objectives that cross organizational lines. The individual writes, reviews, and approves documents of various types, including regulatory submissions, validation protocols and reports, and policies. The Sr. Director takes a leadership role in setting strategic directions, assessing, and bringing new analytical capabilities into the organization, and ensuring that technical capabilities remain focused and current. The Sr. Director collaborates across domains, functions, and PST.

The Sr. Director sets strategic directions and project priorities, providing scientific leadership and oversight, and managing individual performance and cost center budgets. The individual recruits staff as necessary, and mentors, coaches, and develops staff to maximize individual potential, and to grow and retain scientific talent.

Essential Functions

Provide scientific, regulatory, and compliance oversight to the Biologics Analytical Technologies group responsible for analytical methods developed, optimized and performed to support preclinical, phase I through phase III clinical trials including raw material testing; in process, characterization and release bulk drug substance testing; and stability study testing for BDS and DP. Also, supports Phase III/licensure by technology transfer to external partners. (20%) Works through and with others in the global organization, including IPTs, CMC teams, global scientific leads, and other program contributors across Eisai sites to share expertise, ensure optimum decision making, facilitate smooth information exchange, and help drive progress in biopharmaceutical programs. Interact similarly with external partners and collaborators, as appropriate. (20%) Oversee design, implementation and commissioning of new technologies for analytical development. Supports comparability and structure activity relationship studies. Oversight of other areas within the organization may be added at the company's discretion. (15%) Establish scientific objectives, review progress, suggest avenues of pursuit, design studies, analyze and report significant results. Review and approve GxP results for accuracy and compliance. (10%) Lead and provide day-to-day management of Biologics Analytical Technologies group. Recruit, coach, mentor, develop and retain scientific staff, setting goals and managing performance. (10%) Provide strategic vision, sets priorities, develops annual and biennial objectives, creates and maintains annual operating and capital budgets, and creates organizational structures and associated staffing plans. (10%) Understand and contribute to biopharmaceutical regulatory strategy. Author scientific regulatory submission documents and review sections of regulatory documents written by others. Interact with regulatory agencies directly or through correspondence; author responses to Agency comments. (5%) Write, review and/or approve protocols, reports, CoAs, policies, and standard operating procedures. Lead incident investigations as appropriate. (5%) Ensure adherence of operations to cGMP, ICH, EMA and JP Guidelines as well as industry safety standards and OSHA guidelines. (5%)

Scope Measures

The individual contributes to the success of the organization by providing seasoned organizational leadership and deep scientific knowledge. The individual may interact, sharing knowledge, expertise, and reasoned guidance, with external partners and collaborators, regulatory agencies, IPTs, and Eisai program leaders, contributors, and scientists at US, EU and Japanese sites engaged in biopharmaceutical research, development, and commercialization.

Within the immediate organization the individual takes a leadership role in setting strategic directions, assessing and bringing new process capabilities into the organization, and ensuring that technical capabilities remain focused and current. Specifically, this person will contribute to the success of the operation by ensuring the development, optimization, and characterization of validatable analytical methods.

The individual leads groups of scientists, monitors multiple multifaceted development projects, ensuring high productivity and smooth operation of the Biologics Analytical Technolgies organization.

The individual has direct impact on the success of biopharmaceutical manufacturing runs valued at several million USD each, and indirect impact on program development activities representing investments of hundreds of million USD

Requirements

• PhD with 15 yrs or MS with 20 yrs experience in scientific leadership positions, including significant work experience in protein biochemical analysis, cGMP Quality Control, and analytical development in an FDA-regulated industry.

• Demonstrated ability to build effective scientific organizations, establish trust with scientific professionals, and build cohesive teams.

• Extensive experience in technologies utilized in biopharmaceutical analysis, including HPLC, capillary electrophoresis, ELISA, gel-based assays and other relevant assay technologies used with recombinant proteins; demonstrated expertise in specialized techniques, such as peptide mapping with LCMS or cell-based assays.

• Exhibits a complete understanding of principles, concepts, and practices in analytical development, QC testing, and characterization of biopharmaceuticals, including a thorough understanding of industry best practices and emerging trends.

• Extensive experience, knowledge, and expertise in cGMP/ICH/FDA/EMA regulations and guidelines.

• Ability to lead in the identification, investigation, and resolution of complex scientific problems, utilizing external resources as necessary.

• Strong communication and interpersonal skills. Able to write technical and non-technical documents and to summarize and persuasively present technical materials.

#LI-MG1

#IND123

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