CRISPR Therapeutics CMC Lead (Director) in Immuno-Oncology 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 CMC Lead is recognized as the point person for driving strategic decisions, prioritization and timely execution of CMC activities for clinical stage programs across Technical Operations (Manufacturing, Supply Chain, Process Development and Analytical Development), Quality and Regulatory. Furthermore, the CMC Lead is accountable for reinforcing cross-functional alignment to goals, objectives and strategies. Following alignment, the CMC Lead drives achievement of timelines to meet objectives of program teams. This is accomplished through efficient management of the CMC Team, with a focus on driving clear decision making and holding team members accountable. The line of sight is guiding the product into and through clinical trials, process qualification, regulatory application / review / approval and into commercialization. The Lead is accountable to the executive team and program leadership.
A critical responsibility of the CMC Lead is chairing the CMC Team, alongside a partner CMC Project Manager.
The CMC Team venue is where CMC strategy is litigated and decided, shepherded by the CMC Lead. The Lead must ensure that team members are empowered by their departmental head to make decisions. An important skill is the balance of knowing when to make decisions within the CMC Team, taking discussions off-line for further refinement, and escalating to senior leadership when necessary.
We are looking for a demonstrated leader with the breadth of professional experience and the drive to work with internal partners to define and implement our vision to assure robust supply of CRISPR cell therapy products. The ideal candidate will be strategic, highly knowledgeable in cell and gene therapy, have a solid technical operation and program management background, and understand the challenges and impact of managing an organization that can handle multi-products in development, from early-stage through late stage development and into GMP manufacturing. We need someone who can work collaboratively in a rapidly growing company against tight and changing deadlines.
Ensure successful execution of CMC activities to satisfy corporate and program goals, objectives milestones and timelines, while holding CMC members accountable
Leadership of cross-functional technical team pursuing clinical development, regulatory approval and commercial launch of an allogeneic CAR-T therapy
Work closely with clinical, medical and commercial counterparts to ensure CMC foundation exists for proper clinical, regulatory and commercial execution of cell therapy development.
Champion Critical Quality Attributes and Critical Process Parameters in support of IND and BLA filings. Review various regulatory submissions (IND, briefing books) for alignment, and when necessary, contribute to health authority meetings (both preparation and speaking roles).
Ensure proper execution of key BLA-readiness activities such as performance qualification (PPQ) for drug product and critical components (Cas, sgRNA, AAV)
Oversee strategy for bringing on new contract manufacturing organizations (CMOs), including tech transfer, comparability and ongoing clinical supply
Build cohesive strategy and execution for in-process and release analytics, with particular focus on activity and potency assays
Integrate life cycle management projects and follow-on products in the pipeline
Contribute to documenting and refining best practices for CMC activities, such as communication tools (dashboards, timelines) and playbooks (eg, PPQ execution, IND preparedness).
PhD or MS degree in Life Sciences discipline appropriate to gene editing and cell and gene therapy programs at CRISPR TX (immunology, cell biology, biochemical engineering, etc.).
8-10 years industry experience working in cross-functional leadership roles, with demonstrated strength in process and analytical development, cGMP manufacturing, and technical operations, ideally through the lens cell or gene therapy. Fluent in cGMP requirements.
Understanding of biologic clinical and regulatory development pathways, including key milestones such as opening INDs, PPQ, Phase 3 initiation, inspection readiness.
Demonstrated ability to lead through influence, driving decisions through matrix teams and solidifying endorsement with senior management.
Demonstrated experience in management of external partners.
Expresses self clearly and concisely to key stakeholders; document issues and/or concerns concisely and comprehensively; and articulate well-reasoned recommendations for leadership endorsement; adjust style, language and/or terminology appropriate for the audience across the breadth of and through the depth of the organization.
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.
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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