Executive Director, External Manufacturing & Supply Chain

About the role

The successful candidate will be responsible for defining and implementing CRISPR’s vision to assure robust supply of CRISPR products. They will oversee CMO manufacturing operations, manage clinical supply activities, coordinate cross-functional teams, and ensure alignment with the CMC team and clinical operations.

Responsibilities

• Building and maintaining strategic and operational relationships with CRISPR’s CMOs.
• Managing CMO manufacturing operations and deliverables to ensure supply of materials by disciplined tracking of activities for delivery against objectives; managing changes (documentation, alignment); driving performance (metric setting, monitoring).
• Managing all clinical supply activities for our clinical trials across allogeneic and in vivo therapeutic areas.
• Managing all drug product shipping, labeling and distribution to worldwide clinical sites using a network of vendors.
• Coordinating and managing CMO governance meetings, in partnership with CMO program manager and/or business lead.
• Engaging, as needed, in contract negotiation and review. After execution of a contract, act as contract monitor, ensuring both CRISPR and the CMO comply with commitments.
• Developing strong relationships with internal functional leaders, leveraging these relationships for development and alignment of the program objectives.
• Maintaining information flow during project execution from the Technical Operations team to enable monitoring of the relationships with CDMOs and other vendors.

Requirements

• BS/MS in Biology, Chemistry, Chemical/Biochemical Engineering or related scientific discipline.
• 15-20+ years of experience working in biopharmaceutical manufacturing, technical operations, supply chain, or process development.
• Fluent in cGMP requirements.
• Experience in working with third parties and CDMOs for manufacturing operations and clinical supply chain management activities.
• Ability to influence and effectively communicate and collaborate with senior management stakeholders both internally and externally.
• Proven ability to mentor and coach more junior team members and develop a strong team.
• Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.
• Strong leadership and an innate ability to collaborate and build relationships is critical.
• Flexible and comfortable working with ambiguity as the program priorities follow the science and clinical outcomes.
• Self-driven, independently motivated, data driven and excellent problem-solving ability.
• Available to travel both domestically and internationally.

Qualifications

• Advanced degree such as PhD in Life Sciences or a related field and/or an MBA.
• Strong background in aseptic processing.
• Experience in commercialization of new assets and management of post-approval lifecycle.