Alkermes plc (Nasdaq: ALKS) is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases and immuno-oncology. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for diseases that include schizophrenia, depression, addiction, multiple sclerosis and cancer. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio.

JOB DESCRIPTION:

The Executive Director position is responsible for leadership of the Analytical Development department, across Alkermes sites, from Discovery (lead generation, lead optimization and nomination) through clinical development, registration, and commercialization for both small and large molecule programs. The candidate will ensure success on all drug substance and drug product Analytical Development deliverables to CMC teams through both internal and external resources. They will also be responsible for strategic and scientific alignment of the Analytical Development activities and team members with the overall program needs.

The candidate should have a proven track record of leadership, mentorship, and focus on career growth of their teams in a cross-functional environment. They should be a strong role model for the scientific community in the company by effectively managing technical details with their team and providing expert opinions. This individual should maintain and hone state-of-the-art scientific/technical knowledge and develop and champion ideas for new and ongoing projects.

QUALIFICATIONS AND RESPONSIBILITIES:

• Ph.D. in Analytical Chemistry/Chemistry with 15+ years relevant experience in analytical development roles in the pharmaceutical industry

• Expertise in small and large molecule analytical method development and validation


• Extensive knowledge of advanced analytical principles and theories; expertise in analytical laboratory techniques for drug substance and drug product and application of control strategies through all stages of development, including NDA/BLA


• Expertise in all relevant Quality and Regulatory guidelines Leadership and mentorship of entire Analytical Development department


• Ability to drive their team to learn and integrate new technologies and collaborate across CMC functions


• Ability to develop and maintain project plans for analytical resources, timelines, and budgets


• Proven track record of building strong relationships within other CMC functions


• Oversight and review of all relevant Analytical Development source documents for regulatory submissions


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  Excellent written and verbal communication skills, organization, and planning skills and a high level of technical aptitude and creativity; ability to develop and maintain project plans for analytical resources, timelines, and budgets

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.

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Experience Level:
Director

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