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 Bayer and 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, and business offices in London, United Kingdom.
Position Summary
In this key role, the Site Head will drive the short and long-term strategy for drug substance and drug product manufacturing at the companys Framingham site in alignment with organizational objectives and broad portfolio needs. This role will take the site from initial start-up and build a world-class manufacturing operation able to reliably produce and release innovative gene-edited medicines for patients.
The Site Head has oversight and full responsibility for the planning, implementation, execution, and maintenance of manufacturing operations at our Framingham manufacturing facility and entails responsibility for the delivery of safe and efficacious drug product material manufactured at the Site. The Site Head will maintain focus on quality and performance standards and will ensure compliance with applicable GMP and other regulatory guidelines, legal and statutory requirements, as well as any applicable specifications.
Additional responsibilities for this role include management of the local team, operational excellence, people growth and development, budget management, as well as process improvements, owning manufacturing policies, procedures, and production schedules, and managing the manufacturing facilities at the Framingham site.
Responsibilities
- Drive the next chapter of site evolution from initial start-up to build out of processes to ensure smooth and consistent running of operations to ultimately manufacture and release drug product
- Ensure the accomplishment of site objectives to meet patient demand for on-time delivery of medicines according to Quality, GMP, Safety, Environmental, and performance standards as well as statutory, regulatory and other company requirements with continuous improvement mindset
- Responsible for developing the long-term operational strategy for the site in line with corporate strategy and working with the team to develop the operational budget, processes and organizational model
- Establish and/or improve relevant business processes and performance measures (KPIs)
- Ensure a culture of safety, accountability, operational excellence and pride in work across the site, providing necessary support to all team members working in an end to end cross-functional organizational model
- Manage and drive strong cross-functional collaboration across Manufacturing, Operations, Supply Chain, Quality Control, MS&T, and Facilities & Engineering and close partnership with Quality Assurance and G&A groups to meet business objectives for the site
- Effectively partner with CMC and program teams on a regular basis and other internal and external stakeholders as needed
- Responsible for directing, coaching, and holding the site leadership team accountable for delivering site objectives
- Develop a robust talent strategy to ensure well trained operational teams, growth opportunities up and across the organization for individual team members and a strong succession pipeline for site leadership team
Minimum Qualifications
- A post-graduate scientific degree with 15+ years of experience in progressive, multi-functional CMC/Technical Operations leadership roles in biotechnology, pharmaceutical or vaccines companies with direct work experience in Clinical Manufacturing, Quality, Facilities/Engineering and additional exposure in Process Development, Safety and/or Supply.
- With at least 8+ years of senior leadership experience and a successful track record of effective management
- Previous experience in a manufacturing site leadership role in both build and run modes of execution is a must- preferably within a cell and gene therapy manufacturing facility
- Prior experience with aseptic processing is required
- Demonstrable success working in a dynamic and fast-paced environment in a small to medium-sized biotechnology company or equivalent setting within other biopharmaceutical organization
- Experience leading teams across multiple operations functions
- Excellent knowledge of manufacturing processes and GMP requirements for pharmaceutical manufacturing
- Outstanding organizational skills and proven ability to build structure with process orientation
- Strong communication and change management skills
- Strong analytical skills and the ability to effectively integrate big picture vision and key details
- Demonstrated management, leadership, and coaching expertise
- Strong technical acumen and ability to translate and communicate business needs into CMC approach
- Demonstrated success in deploying continuous improvement initiatives (i.e. operational excellence, Lean-Six-Sigma, etc.)
- Solutions orientation to ensure effective problem solving
- Proven success in deploying continuous improvement initiatives (e.g., operational excellence, Lean-Six-Sigma)
- Excellent relationship building skills and ability to partner and work with senior leaders and all levels in the organization
- Natural collaborative skills and roll up the sleeves mindset
- Strong work ethic and demonstrates the highest levels of integrity, respect, and responsibility
Preferred Qualifications
- Prior experience with cell or gene therapy manufacturing
- Demonstrated expertise and technical depth in mRNA processes
- A track-record of contributing to CMC approach for NBEs, BLAs, and INDs filings
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.
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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