Director, External Development & Manufacturing

Alkermes; United States; On-site; USD 180,000 - 240,000; Full time

Job summary

Alkermes seeks a senior leader to drive Pharmaceutical Development activities, overseeing CDMOs, clinical materials forecasting, and Waltham facility scheduling to align development, manufacturing, and program priorities.

You will manage CDMO contracts, governance, budgets, and cross-functional risk, working with Clinical Supply, Quality, and Tech Ops to ensure on-time, in-full delivery through Stage 1 and transitions to Stage 2 as programs progress.

Qualifications

• Exceptional oral and written communication skills.
• Strong project management and cross-functional facilitation abilities.
• Analytical skills to translate program needs into actionable plans.
• High level of technical knowledge of development manufacturing operations and regulatory guidance.

Responsibilities

• Lead Pharmaceutical Development activities that support execution of development programs, including CDMO oversight, clinical materials demand forecasting, facility scheduling, and operational planning.
• Act as the primary business point of contact with CDMOs to facilitate integration within CMC teams and ensure on-time delivery of commitments.
• Manage CDMO timelines, deliverables, and performance against governance model to support quality and program objectives.
• Lead monthly scheduling for the Waltham Clinical Manufacturing Facility balancing priorities and resources.
• Coordinate alignment among PD, Clinical Supply, CMC Project Management, Quality, and manufacturing stakeholders to resolve conflicts.
• Manage submission of RFPs and CDMO SOWs; negotiate contracts and related business documents.
• Establish and monitor KPIs for CDMOs and coordinate periodic reviews; prepare governance reviews.
• Assist in CDMO selection activities with SMEs across departments to support decision-making.
• Analyze business opportunities and risks with CDMOs involved in Stage 1 activities; provide financial & strategic analyses.

Skills

Communication skills

Project management

Operational planning

Cross-functional facilitation

Analytical skills

Development manufacturing

cGMP knowledge

Governance processes

Job description

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.

Key Responsibilities

• Lead Pharmaceutical Development activities that support execution of development programs, including CDMO oversight, clinical materials demand forecasting, facility scheduling, and operational planning.
• Act as the primary business point of contact with CDMOs to facilitate the integration of CDMO activities within CMC teams and ensure on-time, in-full delivery of development and manufacturing commitments.
• Manage CDMO timelines, deliverables, and performance expectations against an established CDMO Governance Model to support product quality, program objectives, and development-stage commitments.
• Lead the monthly scheduling process for the Waltham Clinical Manufacturing Facility, balancing program priorities, resource availability, equipment capacity, material readiness, and operational constraints.
• Facilitate alignment among Pharmaceutical Development, Clinical Supply, CMC Project Management, Quality, and manufacturing stakeholders to proactively identify and resolve demand, capacity, and scheduling conflicts.
• Manage submission of Alkermes RFPs and CDMO SOWs.
• Act as the primary Pharmaceutical Development liaison with Legal, working with key stakeholders on contracts for new and existing CDMOs, including supply agreements, confidentiality agreements, purchase orders, and related business documents.
• Establish and monitor Key Performance Indicators (KPIs) for CDMOs and coordinate periodic reviews of process performance, operational performance, and KPI metrics.
• Coordinate preparation of periodic business and operational review meetings with CDMOs.
• Assist in CDMO selection activities, working with SMEs in Pharmaceutical Development, Strategic Sourcing, Finance, EHSS, Technical Operations, and Quality, as applicable, to prepare competency assessments and support robust decision-making.
• Analyze business opportunities and challenges with CDMOs involved in Stage 1 development activities; provide financial and strategic analyses of decision options and make recommendations to senior management.
• Interface with internal Pharmaceutical Development SMEs, Project Management and CMC Teams on CDMO activities, clinical materials planning, and development manufacturing operations.
• Partner with Pharmaceutical Development SMEs on managing CDMO relationships and internal operational processes.
• Work closely with Technical Operations on CDMOs supporting Phase 3 activities through the end of Stage 1 process validation, with transfer of responsibilities to be finalized at the start of Stage 2 process validation.
• Identify and implement operational improvements, tools, and best practices to strengthen planning, scheduling, governance, and cross-functional execution within Pharmaceutical Development.
• Stay current in external trends and best practices relevant to pharmaceutical development operations, CDMO management, clinical supply planning, and development manufacturing operations.

Knowledge/Skills Required

• Exceptional oral and written communication skills.
• Strong project management, operational planning, and cross-functional facilitation abilities.
• Strong analytical skills with the ability to translate development program needs, clinical demand assumptions, manufacturing capacity, and material constraints into actionable plans.
• High level of 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