Director, External Development & CDMO Operations

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

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.