Director, CMC Project Management

Role Summary

Director, CMC Project Management will lead cross-functional CMC drug development activities across internal Technical Operations, Quality, Regulatory, Device and Clinical teams, and externally with CDMOs. The role focuses on drug substance, drug product, analytical validations, technology transfer, and CDMO operations. Strong communication, stakeholder management, and project management skills are required to develop, manage, and track project plans, timelines, actions, and risks.

Responsibilities

• Provide leadership to cross-functional teams in the oversight, design and execution of process and analytical validations, technology transfers, and operations within CDMOs.
• Lead, track and maintain CMC budget for CDMOs.
• Manage cross-functional project CMC sub-teams for multiple development programs.
• Build and maintain strong positive working relationships with CDMOs.
• Act as single point of contact and timely disseminate key information between internal CMC team, stakeholders and external CDMOs.
• Partner proactively with internal SMEs and cross functional team members to understand strategy, drive decisions, outline activities, identify any risks, gaps and resources constraints to develop and maintain project plan.
• Develop, organize, and maintain dashboards, timelines, project plans and present information to CMC team and stakeholders.
• Identify, track and escalate project risks to senior stakeholders.
• Demonstrate strategic leadership skills including the ability to influence senior stakeholders.
• Prepare agendas, facilitate meetings, capture detailed minutes with key actions and decisions, and monitor open action items for completion.
• Organize project information into shared areas for ease of access.

Qualifications

• Bachelor’s degree in pharmaceutical or biotechnology and minimum 8 years of project management experience leading cross-functional teams in biotechnology related field.
• Minimum of 12 years of experience in Pharmaceutical or Biotechnology related field (large molecule experience preferred) with direct CMC, drug development (pre-clinical to commercial), process transfer, facility change and comparability.
• Proven ability to influence senior stakeholders and clearly and concisely disseminate information within the organization.
• Ability to build strong relationships with cross-functional team members and with external CDMOs/collaborators.
• Highly organized, detailed oriented with strong problem solving and analytical skills.
• Ability to function independently, manage priorities, meet agreed deadlines, adapt to evolving priorities and thrive in fast-paced environment.
• Ability to take accountability, act with senses of urgency, drive decisions, manage conflict and steer towards a resolution.
• Ability to communicate effectively and professionally, both orally and in writing, with internal and external partners.
• Strong knowledge and application of standard Project Management tools with experience in Smartsheet, MS Project, PowerPoint and SharePoint.

Education

• Bachelor’s degree in pharmaceutical or biotechnology.

Additional Requirements

• Ability and willingness to travel as required (25%).