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CRISPR Therapeutics Associate Director, External Manufacturing in Cambridge, Massachusetts

Company Overview

At CRISPR Therapeutics, we are focused on developing transformative gene-based medicines for serious human diseases.

We are rapidly translating our specific, efficient and versatile CRISPR/Cas9 gene-editing platform into therapies to treat hemoglobinopathies, cancer, diabetes and other diseases

Our multi-disciplinary team of world-class researchers and drug developers work every day to translate our CRISPR/Cas9 technology into breakthrough human therapeutics. Our lead program targeting the blood diseases β-thalassemia and sickle cell disease has entered clinical testing, and our immuno-oncology programs, focused on CRISPR/Cas9-edited allogeneic CAR-T cell therapies, have the potential to deliver a new generation of cancer therapies to patients.

Position Summary

The primary focus of the Associate Director, 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 grading for this role reflects the need for a strategic thinker who is able to 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 is ultimately accountable for successful execution of the program 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 to define and implement our vision to assure robust supply of CRISPR cell therapy products. The right candidate will be strategic, 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 functional leaders, leveraging these relationships for development and alignment of the program objectives.

  • Building and maintaining strategic and operational relationships with CRISPRs CMOs.

  • Identifying and escalating business-critical issues affecting supply and timelines as necessary, providing recommendations, mitigations and potential solutions.

  • Managing the cross-functional teams, building into a high-functioning team where team members are accountable as both functional as well as program representatives

  • 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.

Responsibilities

  • Establish alignment 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 strategic decisions for the program.

  • Lead the cross-functional team, setting and managing the team priorities in alignment with the program needs.

  • Interface closely with each key CMO as the primary CRISPR contact, 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.

  • Coordinate and manage 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.

Required Qualifications

  • Bachelor?s degree in Life Sciences discipline appropriate to cell therapy programs (immunology, cell biology, genetic engineering, etc.).

  • 8+ years of experience working in biopharmaceutical manufacturing, technical operations, supply chain, or process development. Fluent in cGMP requirements.

  • Demonstrated ability to lead matrix teams.

  • Demonstrated experience in management of external partners.

  • 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.

Preferred Qualifications

  • Advanced degree in Life Sciences

  • Strong background in oligonucleotide and/or Cas9 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.

To view our Privacy Statement, please click the following link: http://www.crisprtx.com/about-us/privacy-policy

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