Director, External Development & Manufacturing

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, including demand forecasting, manufacturing scheduling, business reviews, and operational issue resolution.
• Demonstrated ability to interact and collaborate within an interdisciplinary team environment on creative 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.

Qualifications

• 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.