Executive Director, External Manufacturing &… at CRISPR… · Boston

Job Description:

Company Overview

Since its inception over a decade ago, CRISPR Therapeutics has 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 Therapeutics has established strategic partnerships with leading companies including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California.

Position Summary

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.

The function will work closely with the CMC Team for program(s), ensuring the strategy and timelines are clear and aligned before translating these into executional objectives. A key feature of this position is matrix-management of cross-functional teams to execute the program strategic objectives across the lifecycle of the asset. The role will also ensure effective coordination with Clinical Operations and support the successful start-up of new clinical sites and support the needs of expanding clinical trials and commercialization. The incumbent will ensure inventory management for all critical starting materials and critical components produced at our network of CMOs.

The leveling for this role reflects the need for a seasoned technical operations leader who has worked across disciplines within CMC and who brings particular depth in external manufacturing and supply chain. This leader will be a strategic thinker who is able to negotiate difficult conversations with, and drive performance at the CMOs and who can distill trade-off decisions into recommendations for escalation to leadership and has significant experience with clinical supply management, hiring and supervising a team and building the core of a scalable and sustainable clinical supply chain team. This role is ultimately accountable for successful execution of the program at the CMOs and across the supply chain network to ensure seamless delivery of drug product to patients globally. As this role interfaces with our external partners, the job may require periods of extensive travel (for example, during tech transfer, PPQ and PAI), nationally or internationally. Routine travel is estimated at 20%.

Responsibilities

• 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.

Minimum Qualifications

• 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. Ability to execute and follow-through to completion.
• 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.

Preferred 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.

Competencies

• Collaborative – Openness, One Team
• Undaunted – Fearless, Can-do attitude
• Results Orientation – Delivering progress toward our mission. Sense of urgency in solving problems.
• Entrepreneurial Spirit – Proactive. Ownership mindset.

CRISPR Therapeutics believes in fostering a dynamic workplace that balances remote work flexibility with the benefits of in-person interactions. Our employees work at least three days on-site, creating a collaborative work environment, where we cultivate mentorship opportunities, increase cross-functional communication and offer opportunities for our employees to connect. Certain lab based and manufacturing positions are located fully on-site.

Executive Director: Base pay range of $260,000 to $290,000+ bonus, equity and benefits

The range provided is CRISPR Therapeutics’ reasonable estimate of the base compensation for this role. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities.

CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.

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