Associate Director, CMC Program Management

Role Summary

We are seeking a highly skilled and motivated Associate Director of CMC Program Management reporting to the Senior Director, CMC Program Management. The ideal candidate will partner with the Vice President, Manufacturing Operations to oversee and execute on CMC commercial, lifecycle management, and preclinical activities at Vera. The successful candidate will be detail-oriented, self-directed, flexible, and able to manage the workload to meet programmatic milestones.

Responsibilities

• Develop, maintain, and track project timelines and deliverables for CMC activities, ensuring alignment with organizational and departmental objectives.
• Coordinate commercial supply readiness and next generation process development activities across CMC, quality, regulatory, commercial, and external CDMO/CMOs.
• Act as a liaison between CMC team and external partners, consolidate and disseminate key decisions and updates across cross-functional workstreams.
• Support CMC Subteam and other governance forums to develop, track and execute on CMC functional objectives and lifecycle management initiatives.
• Work with CMC team to develop, manage and track the CMC budget.
• Provide CMC project management support, both internally and externally with vendors. This includes activities such as drug substance/drug product development, manufacturing, and supply chain oversight. Proactively track and manage activities at vendors and facilitate resolution of issues to keep project activities on track.
• Create and maintain program management tools to communicate timelines, deliverables, issues, risks, and mitigations. Ensure cross functional alignment on program status including expectations, opportunities, and risks.

Qualifications

• BS/MS degree in a scientific or engineering discipline. PMP is a plus.
• 8 years of biotech experience in any of the following sub-disciplines; process development, manufacturing, and/or analytical development.
• 5 years of CMC program management experience.
• Proficient in Microsoft Project.
• Experience in Smartsheet is preferred but not required
• High level of attention to detail.
• Ability to work with ambiguity, and create new, more efficient processes; desire to bring order and organization to a newly developing organization
• Ability to communicate effectively with stakeholders across the organization at all levels.
• Proven ability to manage competing priorities, budgets, and timelines in a fast-paced, rapid-growth environment.
• Highly skilled at working collaboratively with cross-functional teams and contractors to drive results and meet company objectives.
• Excellent written and verbal communication skills, including a demonstrated ability to effectively communicate in a program team environment, within department, among functional groups, and external collaborators.
• Self-directed and proactive with ability to function independently, exercise good judgment, and respond quickly and effectively to changing environments.

Education

• BS/MS degree in a scientific or engineering discipline. PMP is a plus.