CMC Program Manager

Reporting to: Director CMC Program Management

The CMC Program Manager will foster a team environment and is responsible for the coordination of multiple projects to achieve CMC milestone commitments to programs. The CMC Program manager is expected to have familiarity with the underlying CMC functions (Mfg, QC, QA, RA) and leads cross functional teams to plan, prioritize, and develop timelines in partnership with CMOs. The role requires the ability to read and interpret complex information; manage ambiguity, strategy changes or unexpected events; establish and maintain relationships with CMOs; clearly communicate with stake holders; effectively obtain agreement from multiple parties and influence others without direct authority.. Stake holders include internal staff, academic partners and the Company's designated Contract Manufacturing Organizations (CMOs).

Responsibilities

• Lead the planning and execution of a program stage or milestone deliverable
• Utilize project management tools and best practices to identify, plan and execute CMC activities required to fulfil milestone(s).
• Lead one or more project teams
• Document, track and communicate progress against project timelines, milestones and budgets
• Lead/co-lead with CMO cross-functional project team meetings and drive on-time completion of deliverables
• Facilitate problem-solving, contingency planning, and decision-making
• Co-ordinate and track status of cross-functional communication and integration activities associated with each project
• Other activities as may be assigned

Requirements

REQUIREMENTS

The ideal candidate for this position will have demonstrated experience of integrated program/project management in the biotech/pharma industry.

Candidate must possess:

• A minimum BS in Biological Sciences, Bioengineering, Chemistry or an associated discipline
• Proven experience in the biotechnology or pharma industry with a primary focus on project/program management of CMC related activities
• Solid understanding of biological product development phases and regulatory requirements

Education & skills

• Experience managing CMO/CTO relationships and projects
• Working knowledge of US and European regulatory requirements
• Excellent interpersonal skills
• Outstanding organizational skills
• Excellent written and oral communication skills
• Advanced experience with MS project, Excel, Power Point and Word
• Ability to operate in a fast-paced, multi-disciplinary industrial environment
• Travel to US and international CMO and CTO sites may be required