[Hiring] Director, CMC Project Management @ProKidney

Role Description

The Director, CMC Project Management will be responsible for managing activities related to CMC Planning. In conjunction with internal subject matter experts and consultants, the Director will be responsible for identifying CMC Gaps and implementing cross functionally aligned CMC strategy to support late stage and commercial CMC regulatory submissions, coordinating the planning and on-time completion of CMC activities through BLA filing, PLI and approval. The successful candidate must possess a technical understanding of the inter-disciplinary nature of cell therapy development, demonstrated with previous experience. The position requires timeline and deliverable management with close collaboration with Operation, Quality and Regulatory, and requires collaboration with program management to provide sufficient details into the Integrated Project Plan (IPP).

The position reports to the Vice President, Technical Operations Strategy, with a dotted line to Program Management (PMO).

Key Responsibilities

• Translate the CMC strategy into project plans with defined deliverables and deadlines.
• Drive cross-functional teams and manage inter-dependencies across Technical Operations functions.
• Develop, drive and maintain detailed CMC Plan and Major Milestones activities across Technical Operations.
• Plan and track content draft, review and delivery dates against identified timelines.
• Proactively identify and prioritize program risks and develop and monitor risk mitigation-contingency plans.
• Facilitate CMC GAP Assessment, Risk Analysis, strategy discussions and other meetings.
• Lead data-driven decision-making for project continuation, acceleration, re-prioritization, redesign or termination.
• Provide periodic status reports and coordinate documentation of project deliverables.
• Escalate timeline slips, emerging risks and unresolved dependencies promptly.
• Serve as the primary CMC point of contact for internal stakeholders.
• Lead and prioritize the project managers supporting CMC projects.
• Own the standards, templates and cadence for CMC Planning.
• Communicate effectively to team members and executives through written, verbal and project summary updates.

Secondary Responsibilities

• Collaborate with Operations, QA, RA and other members of the CMC team to plan, sequence and track technology transfer, comparability, process scale-up and validation activities.
• Contribute to the development of CMC Planning within the context of an Integrated Development plan (IDP).
• Identify risks within the CMC strategic development plan.
• Report on a defined cadence to the VP, Program Leadership & Management (PMO).

Qualifications

• Bachelor's degree in sciences or related field; Advanced degree (MS, PhD) preferred.
• 12+ years of relevant biopharmaceutical industry experience with 6+ years of cell therapy experience.
• Prior background in CMC project management at a biotech/pharma company focused on biologics/cell & gene therapy.
• Experience leading project managers or a project management team.

Skills/Abilities

• Must be a “hands-on” and active contributor in all aspects.
• Must have sufficient CMC depth to identify dependencies, risks and gaps across manufacturing, quality, analytical and regulatory activities.
• Must have a proven track record of effective collaboration with cross functional CMC teams.
• Must have demonstrated ability to multi-task across product pipelines and support short and long-term corporate goals.
• Must have high ethical standards and be compliance focused.

Requirements

• Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.