Director, External Development & Manufacturing

Alkermes•Waltham, MA

11h•$216,000 - $235,000•Hybrid

About The Position

The Director, External Development & Manufacturing leads Pharmaceutical Development activities that enable execution of Alkermes drug development programs. The role oversees contract development and manufacturing organizations (CDMOs) involved in development and manufacturing of drug development candidates through the end of Stage 1 process validation, with responsibilities transitioning to Technical Operations as programs move toward Stage 2 process validation. It also provides operational leadership for monthly scheduling of the Waltham Clinical Manufacturing Facility, aligning development, manufacturing, clinical supply, and program priorities. The position supports Pharmaceutical Development operations by tracking project progress and deliverables, onboarding CDMOs, managing contracts, coordinating resource and facility planning, and working with CMC Project Managers to monitor budgets, timelines, and operational risks. It works closely with Pharmaceutical Development subject matter experts, CMC Teams, Clinical Supply, Strategic Sourcing, Finance, EHSS, Quality, Technical Operations, Project Management, Legal, and other stakeholders. The role calls for strong scientific and operational capabilities, excellent communication, and effectiveness in a matrixed, cross-functional environment. This position follows a hybrid workplace model, with at least three days per week onsite at the Waltham, Massachusetts office and the remainder of work time from home; it is not eligible for fully remote work. The annual base salary range is $216,000–$235,000, and the role is eligible for an annual performance pay bonus. Alkermes states that it offers a competitive benefits package, with additional details on its careers website.

Requirements

Ph.D., M.S., or B.S. in a scientific, engineering, pharmaceutical sciences, or related discipline.
At least 10 years of relevant pharmaceutical or biotechnology industry experience.
Exceptional oral and written communication skills.
Strong project management, operational planning, and cross-functional facilitation abilities.
Strong analytical skills, including the ability to translate program needs, clinical demand assumptions, manufacturing capacity, and material constraints into actionable plans.
High technical knowledge of development manufacturing operations, facility capabilities, plant equipment, and operational constraints.
Significant knowledge of cGMPs and applicable regulatory guidance.
Ability to lead recurring governance processes, including demand forecasting, manufacturing scheduling, business reviews, and operational issue resolution.
Demonstrated ability to collaborate in interdisciplinary teams on problem-solving, prioritization, and operational decision-making.
Ability to influence without direct authority and drive alignment across technical, clinical supply, quality, finance, sourcing, and manufacturing stakeholders.
Demonstrated capability to manage technical, operational, and business details across multiple programs and stakeholders.
Experience working with outsourced CDMOs in a business oversight capacity.

Nice To Haves

Previous process development, clinical manufacturing, pharmaceutical operations, and/or manufacturing experience.
Experience with clinical materials planning, demand forecasting, supply planning, production scheduling, or related operational planning processes.

Responsibilities

Lead Pharmaceutical Development activities supporting development programs, including CDMO oversight, clinical materials demand forecasting, facility scheduling, and operational planning.
Serve as the primary business point of contact with CDMOs, integrating their activities with CMC teams and ensuring on-time, in-full delivery of development and manufacturing commitments.
Manage CDMO timelines, deliverables, and performance expectations in accordance with the CDMO Governance Model.
Lead monthly scheduling for the Waltham Clinical Manufacturing Facility, balancing program priorities, resources, equipment capacity, material readiness, and operational constraints.
Coordinate Pharmaceutical Development, Clinical Supply, CMC Project Management, Quality, and manufacturing stakeholders to identify and resolve demand, capacity, and scheduling conflicts.
Manage submission of Alkermes requests for proposals (RFPs) and CDMO statements of work (SOWs).
Act as the primary Pharmaceutical Development liaison with Legal on contracts and related documents for new and existing CDMOs, including supply agreements, confidentiality agreements, and purchase orders.
Establish and monitor CDMO key performance indicators (KPIs), and coordinate periodic reviews of process performance, operational performance, and KPI metrics.
Coordinate preparation of periodic CDMO business and operational review meetings.
Assist with CDMO selection, working with relevant subject matter experts and business functions to prepare competency assessments and support decision-making.
Analyze business opportunities and challenges involving CDMOs for Stage 1 development activities; provide financial and strategic analyses and recommendations to senior management.
Interface with Pharmaceutical Development subject matter experts, Project Management, and CMC Teams on CDMO activities, clinical materials planning, and development manufacturing operations.
Partner with Pharmaceutical Development subject matter experts to manage CDMO relationships and internal operational processes.
Work with Technical Operations on CDMOs supporting Phase 3 activities through the end of Stage 1 process validation, with responsibility transfer finalized at the beginning of Stage 2 process validation.
Identify and implement operational improvements, tools, and best practices for planning, scheduling, governance, and cross-functional execution.
Stay current on external trends and best practices in pharmaceutical development operations, CDMO management, clinical supply planning, and development manufacturing operations.