Executive Director, External Manufacturing & Supply Chain
Scorpion Therapeutics, Boston, Massachusetts, us, 02298
Role Summary
Lead external manufacturing and supply chain operations for CRISPR Therapeutics. You will manage relationships with CMOs and CDMOs, oversee starting materials, drug product, packaging, labeling, shipping, and distribution, and drive clinical supply management for CRISPR-led trials, including allogeneic cell therapies and in vivo lipid nanoparticle therapies. You will coordinate with the CMC team and clinical operations, lead cross‑functional teams, and build a scalable, compliant clinical supply chain. Expect travel up to 20% domestically and internationally.
Responsibilities
Building and maintaining strategic and operational relationships with CRISPR's CMOs.
Manage CMO manufacturing operations and deliverables to ensure supply of materials by disciplined tracking of activities 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, with team members accountable as both functional and program representatives.
Maintain financial responsibility for CMO and vendor spend, including budget allocation, negotiating statements of work, ensuring purchase requisitions are raised and POs 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.
Identify and elevate business‑critical issues affecting supply and timelines, providing recommendations, mitigations and potential solutions.
Establish alignment of objectives and priorities in close coordination with the CMC team, clinical operations and other functions as needed, representing the CMOs in strategic decisions for the program.
Engage in contract negotiation and review as needed; after execution, monitor contracts to ensure both CRISPR and the CMO meet commitments.
Develop strong relationships with internal functional leaders to align objectives.
Maintain information flow during project execution from the Technical Operations team to monitor relationships with CDMOs and other vendors.
Coordinate and manage CMO governance meetings, in partnership with the CMO program manager and/or business lead.
Provide leadership to drive a fast‑paced, highly efficient learning culture.
Champion a collaborative, transparent, data‑driven, “make it happen” culture.
Qualifications
Required: 15–20+ years of experience in biopharmaceutical manufacturing, technical operations, supply chain, or process development; fluent in cGMP.
Required: Experience working with third parties and CDMOs for manufacturing operations and clinical supply chain management.
Required: Ability to influence and communicate with senior management stakeholders both internally and externally.
Required: Proven ability to mentor and coach junior team members and develop a strong team.
Required: Ability to work in a collaborative environment; influence and execute to completion.
Required: Strong leadership and ability to build relationships.
Required: Flexible and comfortable working with ambiguity as priorities evolve.
Required: Self‑driven, data‑driven, and excellent problem‑solving abilities.
Required: Availability to travel domestically and internationally.
Preferred: Strong background in aseptic processing.
Preferred: Experience commercializing assets and managing post‑approval lifecycle.
Education
BS/MS in Biology, Chemistry, Chemical/Biochemical Engineering or related scientific discipline.
Advanced degree such as PhD in Life Sciences or a related field and/or an MBA.
Skills
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.
Additional Requirements
Travel: May require periods of extensive travel (for example, during tech transfer, PPQ and PAI); routine travel is estimated at 20%.
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Responsibilities
Building and maintaining strategic and operational relationships with CRISPR's CMOs.
Manage CMO manufacturing operations and deliverables to ensure supply of materials by disciplined tracking of activities 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, with team members accountable as both functional and program representatives.
Maintain financial responsibility for CMO and vendor spend, including budget allocation, negotiating statements of work, ensuring purchase requisitions are raised and POs 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.
Identify and elevate business‑critical issues affecting supply and timelines, providing recommendations, mitigations and potential solutions.
Establish alignment of objectives and priorities in close coordination with the CMC team, clinical operations and other functions as needed, representing the CMOs in strategic decisions for the program.
Engage in contract negotiation and review as needed; after execution, monitor contracts to ensure both CRISPR and the CMO meet commitments.
Develop strong relationships with internal functional leaders to align objectives.
Maintain information flow during project execution from the Technical Operations team to monitor relationships with CDMOs and other vendors.
Coordinate and manage CMO governance meetings, in partnership with the CMO program manager and/or business lead.
Provide leadership to drive a fast‑paced, highly efficient learning culture.
Champion a collaborative, transparent, data‑driven, “make it happen” culture.
Qualifications
Required: 15–20+ years of experience in biopharmaceutical manufacturing, technical operations, supply chain, or process development; fluent in cGMP.
Required: Experience working with third parties and CDMOs for manufacturing operations and clinical supply chain management.
Required: Ability to influence and communicate with senior management stakeholders both internally and externally.
Required: Proven ability to mentor and coach junior team members and develop a strong team.
Required: Ability to work in a collaborative environment; influence and execute to completion.
Required: Strong leadership and ability to build relationships.
Required: Flexible and comfortable working with ambiguity as priorities evolve.
Required: Self‑driven, data‑driven, and excellent problem‑solving abilities.
Required: Availability to travel domestically and internationally.
Preferred: Strong background in aseptic processing.
Preferred: Experience commercializing assets and managing post‑approval lifecycle.
Education
BS/MS in Biology, Chemistry, Chemical/Biochemical Engineering or related scientific discipline.
Advanced degree such as PhD in Life Sciences or a related field and/or an MBA.
Skills
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.
Additional Requirements
Travel: May require periods of extensive travel (for example, during tech transfer, PPQ and PAI); routine travel is estimated at 20%.
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