Vp Of Program Management & Operations

Position: Vice President of Program Management & Operations

This role will provide planning, management and executional leadership and support in relation to CMC, Quality and Regulatory activities in preparation of INDs, BLAs and other regulatory documents/applications submissions. The individual for this role must be project management expert and possess strong leadership skills. The responsibilities of primary importance are to ensure the successful and time-sensitive planning, compliance, and overall program management and operational support of all activities.

Responsibilities

• Assist in planning, coordinating and contributing to meetings with regulatory agencies.
• Incorporate PM guidelines and mentor cross-functional teams as needed.
• Work with senior management to assess current CMC pathway to registration for Capricor’s therapeutic product candidates.
• Actively manage risks, reporting and establish program mitigation plans.
• Communicate status of activities to executive leadership team and appropriate team members on a regular basis
• Present project and program governance plans to management and obtain approval as needed.
• Ensure alignment, collaboration, execution and delivery across the cross functional teams.
• Establish and direct vision and lead all aspects of setting plans, timelines, identifying risks and constraints with respect to CMC activities.
• Support all regulatory submission activities to ensure milestones are met.
• Partner with leadership to develop and refine project plans including schedule, budgetary baselines and risks.
• Manage and coordinate necessary activities to deliver BLA submission according to the established milestones and FDA guidelines.

Requirements

• Master’s or Ph.D. preferred
• 10+ years of hands-on cGMP biologics manufacturing experience in pharmaceutical/biotech industry
• Strong scientific background with deep knowledge of biologics, specifically cell therapy experience a plus
• Ability to deliver to a high standard of quality
• Must have full working knowledge of cGMP and applicable FDA regulations
• Ability to manage multiple projects simultaneously, with ability to prioritize in a fast paced, dynamic environment
• Demonstrated critical thinking and problem-solving skills
• Exceptional communication and interpersonal skills
• Ability to collect and analyze data and information to determine paths for process improvement and potential root cause analysis