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:
- In support of the CMC strategy, translate the strategy into project plans with defined deliverables and deadlines, and drive the cross-functional teams and manage inter-dependencies across Technical Operations functions to complete them.
- 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
- Facilitating CMC GAP Assessment, Risk Analysis, strategy discussions and other meetings and operational mechanisms to drive cross-functional decision making, and successful execution of program plans for facilitating CMC Planning activities.
- Lead data-driven decision-making to facilitate timely, objective recommendations for continuation, acceleration, re-prioritization, redesign or termination of projects, along with necessary change management recommendations.
- Provide periodic status reports and coordinate documentation of project deliverables and escalate timeline slips, emerging risks and unresolved dependencies, with the schedule and inspection consequence stated.
- Escalate timeline slips, emerging risks and unresolved dependencies promptly, with the schedule and filing/inspection consequence stated.
- Serve as the primary CMC point of contact for internal stakeholders, representing CMC at project team meetings.
- Lead and prioritize the project managers supporting CMC projects.
- Own the standards, templates and cadence for CMC Planning, so CMC plans, milestones and risk records are produced and maintained consistently across the group.
- Communicate effectively to team members and executives through written, verbal and project summary updates, providing line of sight to key issues and accomplishments.
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 and their deliverables, in support of routine/non-routine development and CMC cGMP activities
- Contribute to the development of CMC Planning within the context of an Integrated Development plan (IDP), to identify risks and potential risk mitigation strategy with the overall IDP. Identify risks within the CMC strategic development plan.
- Dotted line to the VP, Program Leadership & Management (PMO): report on a defined cadence, providing sufficient information on the CMC plan to feed the Integrated Project Plan (IPP).
Qualifications:
- Education/Training:
- Bachelor's degree in sciences or related field. Advanced degree (MS, PhD) preferred.
- Experience:
- 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 working with SME’s.
- 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.
ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.
Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.
