Executive Director, External Manufacturing & Supply Chain

Executive Director, External Manufacturing & Supply Chain (Project Management)

Job Description:

Company Overview

Since its inception over a decade ago,CRISPR Therapeuticshas transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines.

To accelerate and expand its efforts,CRISPR Therapeuticshas established strategic partnerships with leading companies including Vertex Pharmaceuticals.

CRISPR Therapeutics AGis headquartered inZug, Switzerland, with its wholly-ownedU.S.subsidiary,CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusettsand San Francisco, California.

We are looking for a demonstrated technical operations leader with the breadth of professional experience and the drive to work with both internal and external partners to define and implement our vision to assure robust supply of CRISPR products. The successful candidate will be strategic, highly knowledgeable in LNP and oligonucleotide manufacturing with experience in cell therapy and biologics manufacturing as well, have a solid technical operations background, and understand the challenges and impact of managing CMO partners and supply chain operations.

They will be responsible for driving execution of CRISPR's program objectives with external manufacturing partners (CMOs and CDMOs) and Product Supply Management including Clinical Supply Chain management for CRISPR managed trials including allogeneic cell therapies and in vivo lipid nanoparticle therapies. This includes all manufacturing oversight for Contract Manufacturers for starting materials, including cell collections from healthy donors, critical components, and drug product.

Additionally, the role is responsible for material management for all manufacturing operations, packaging & labeling, shipping, and distribution operations.

• Building and maintaining strategic and operational relationships with CRISPRs CMOs.
• Manage 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).
• Manage all clinical supply activities for our clinical trials across allogeneic and in vivo therapeutic areas.
• Manage all drug product shipping, labeling and distribution to worldwide clinical sites using a network of vendors
• Manage cross-functional teams, -- team members are accountable as both functional as well as program representatives.
• Maintain financial responsibility for CMO and vendor spend, managing the budget allocation, negotiating work statements, ensuring purchase requisitions are raised and PO's are reconciled.
• Provide regulatory filing support (IND, BLA, etc.) as needed.
• Oversee CMO due diligence during new CMO selection to vet capabilities, risks and investments required.
• Identifying and escalating business-critical issues affecting supply and timelines as necessary, providing recommendations, mitigations and potential solutions.
• Establish alignment of objectives and priorities in close coordination with CMC team, clinical operations and other functions as needed, representing the CMO(s) in strategic decisions for the program.
• Engage, 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.
• Maintain information flow during project execution from the Technical Operations team to enable monitoring of the relationships with CDMOs and other vendors.
• Coordinate and manage CMO governance meetings, in partnership with CMO program manager and/or business lead.
• Provide leadership and management support for activities to drive a fast paced, highly efficient learning culture.
• Be a champion of a highly collaborate, transparent, data driven, ‘make it happen', culture.

• BS/MS in Biology, Chemistry,…