CRISPR Therapeutics Manager, External Manufacturing in Cambridge, Massachusetts
CRISPR Therapeutics is a leading gene editing company focused on developing transformative gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 platform. CRISPR/Cas9 is a revolutionary gene editing technology that allows for precise, directed changes to genomic DNA. CRISPR Therapeutics has established a portfolio of therapeutic programs across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, and rare diseases. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic collaborations with leading companies including Bayer, Vertex Pharmaceuticals and ViaCyte, Inc. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Cambridge, Massachusetts, and business offices in San Francisco, California and London, United Kingdom.
The primary focus of the Manager, External Manufacturing is driving execution of CRISPR’s program objectives with external manufacturing partners (CMOs and CDMOs). The role will work closely with the CMC Team for the specific program, 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 successful candidate needs to be able to work independently and negotiate difficult conversations with, and drive performance at, the CMOs and who can distil trade-off decisions into recommendations for escalation to leadership. This role will be critical in the successful execution of the program(s) at the CMOs.
We are looking for a demonstrated leader with the breadth of professional experience and the drive to work with both internal and external partners and implement our vision to assure robust supply of CRISPR cell therapy products. The right candidate will be results oriented, highly knowledgeable in protein biochemistry or cell therapy, have a solid technical operations background, and understand the challenges and impact of managing CMO partners. We need someone who is able to work collaboratively in a rapidly growing company against tight and changing deadlines. In many cases, since the technology is still emerging, our CMOs are learning with us, adding another dimension of complexity and ambiguity.
As this role interfaces with our external partners, the job may require periods of extensive travel nationally or internationally. Routine travel is estimated at 20 - 25%.
The key deliverables for this role are to ensure reliable supply of our assets through:
Developing strong relationships with internal functions, leveraging these relationships for alignment of the program objectives.
Building and maintaining operational relationships with CRISPRs CMOs.
Identifying and escalating business-critical issues affecting supply and timelines as necessary, providing recommendations, mitigations and potential solutions.
Supporting the cross-functional teams and being accountable for functional deliverables to support the program(s)
Driving delivery of the program objectives against aggressive timelines, including managing risks and issues that arise
Managing and coordinating post-approval lifecycle strategy implementation for programs, including establishing a robust business continuity program with strategic CMOs.
Execution of objectives and priorities in close coordination with CMC team, clinical operations, supply chain planning and other functions as needed, representing the CMO(s) in decisions for the program.
Drive deliverables in the cross-functional team, supporting and managing the team priorities in alignment with the program needs.
Interface closely with each key CMO, providing direction to and partnering with the CMO program manager, site leadership and business lead as appropriate.
Manage CMO and CRISPR expectations by disciplined tracking of activities for delivery against objectives; managing changes (documentation, alignment); driving performance (metric setting, monitoring).
Scrutinize CMO systems related to CRISPR programs, identifying risks and negotiating mitigations to assure supply continuity and delivery against demand requirements.
Support CMO governance meetings, in partnership with CMO program manager and/or business lead.
Drive issue resolution, escalating appropriately to internal and/or joint governance if required.
As needed, partner with Strategic Sourcing for CMO due diligence during new CMO selection to vet capabilities, risks and investments required.
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.
Provide regulatory filing support (IND, BLA, etc) as needed
Inventory management (in partnership with Supply Chain)
Drive a continuous improvement mindset (e.g. process improvements: throughput, cycle time, robustness)
Maintain financial responsibility for CMO spend, managing the budget allocation, negotiating work statements, ensuring purchase requisitions are raised and PO’s are reconciled
Oversee change management (pre- and post-approval), ensuring owners are identified and change controls are raised and assessed in a timely manner.
Bachelor’s degree in Life Sciences or Engineering discipline appropriate to cell therapy programs (immunology, cell biology, genetic engineering, etc.).
5+ years of experience working in biopharmaceutical manufacturing, technical operations, supply chain, or process development. Fluent in cGMP requirements.
Demonstrated ability to support and lead in matrix teams.
Ability to influence senior management both internally and externally.
Ability to expresses self clearly and concisely to key stakeholders; document issues and/or concerns concisely and comprehensively; assess options cross-functionally and articulate well-reasoned recommendations for leadership endorsement; adjust style, language and/or terminology appropriate for the audience.
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
Passion for innovation and problem-solving.
Advanced degree in Life Sciences
Demonstrated experience in management of external partners.
Strong background in T-Cell technology and manufacture
Experience in commercialization of new assets and management of post-approval lifecycle.
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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