Director, External Development & Manufacturing

This position is responsible for leading key Pharmaceutical Development activities that enable effective execution of Alkermes drug development programs. Core responsibilities include business oversight of contract development and manufacturing organizations (CDMOs) involved in development activities and manufacturing of Alkermes drug development candidates through the end of Stage 1 process validation, with appropriate transition of responsibilities to Technical Operations as programs progress toward Stage 2 process validation. The role also provides operational leadership for monthly scheduling of the Waltham Clinical Manufacturing Facility to ensure alignment of development, manufacturing, clinical supply, and program priorities. This individual will support Pharmaceutical Development operations by tracking project progress and deliverables, onboarding new CDMOs, managing contracts, coordinating resource and facility planning, and working with CMC Project Managers to monitor budgets, timelines, and operational risks. These responsibilities require strong cross-functional collaboration with Pharmaceutical Development SMEs, CMC Teams, Clinical Supply, Strategic Sourcing, Finance, EHSS, Quality, Technical Operations, Project Management and other key stakeholders. The candidate will have strong scientific and operational skills, excellent communication skills, and the ability to thrive in a matrixed, cross-functional team environment.

- Ph.D., M.S., or B.S. in a scientific, engineering, pharmaceutical sciences, or related discipline with 10+ years of relevant pharmaceutical or biotechnology industry experience.
- Previous process development, clinical manufacturing, pharmaceutical operations, and/or manufacturing experience preferred.
- Experience with clinical materials planning, demand forecasting, supply planning, production scheduling, or related operational planning processes preferred.
- Demonstrated capability to effectively manage technical, operational, and business details across multiple programs and stakeholders.
- Experience working with outsourced CDMOs in a business oversight capacity.

Alkermes has recently adopted a hybrid working environment to support and meet the needs of employees and this role will operate in a flexible environment with 60% of time in the office and 40% from home. This position is eligible for the hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week. This role is not eligible for fully remote work.

The annual base salary for this position ranges from $216,000 to $235,000. In addition, this position is eligible for an annual performance pay bonus. Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package. Additional details can be found on our careers website: www.alkermes.com/careers#working-here

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