CRISPR Therapeutics

Job Description:

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 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.

Position Summary

Reporting to the Director, Supply Chain, the Manager/Senior Manager of Supply Chain will be responsible for managing and optimizing global supply to ensure timely availability of clinical supplies for clinical trials. This role requires the incumbent to develop and maintain strong collaborative and cooperative working relationships with team members across different functions and at different levels within the organization. The ideal candidate will have a deep understanding of end-to-end supply chain networks and strong analytics to deliver cost-effective supply chain solutions while balancing multiple business objectives. The position requires enthusiasm, passion, high attention to detail, and a desire to create new medicines for patients.

Responsibilities

• Manage the supply planning and inventory management for finished goods, drug products, drug substances, and critical components across multiple clinical programs.
• Collaborate with CMC, Clinical Operations, QA, Regulatory to generate label/package specifications, oversee approvals for multiple countries/regions, and provide support for IND/IMPD/CTA filings as required.
• Plan and oversee the secondary packaging, labeling activities with CMOs, and facilitate the process through release and global distribution.
• Work closely and proactively with internal/external stakeholders to ensure seamless operation of clinical trials and address any challenges.
• Identify and implement innovative and cost-effective solutions to optimize the supply chain network amid ambiguity and rapid growth.
• Participate/lead investigations, change management in close collaboration with Quality, as applicable.
• Identify issues and/or risks with meeting clinical supply requirements and suggest solutions to meet timelines.
• Author/revise SOPs and business process work instructions. Define and implement KPIs/metrics related to supply and demand.
• Manage budget forecasting activities with the supply chain function.

Minimum Qualifications

• BS/BA in supply chain management or related fields.
  • Manager: 7-10+ years of experience working within a cGMP clinical supply chain function in the biotechnology or pharmaceutical industry
  • Senior Manager: 10+ years of experience working within a cGMP clinical supply chain function in the biotechnology or pharmaceutical industry
• Proven success in leading cross-functional projects to establish new supply chain capabilities.
• Demonstrated expertise in supply planning, inventory management, and demand forecasting.
• Excellent communication and interpersonal skills with the ability to work with uncertainty and thrive in a fast-paced, dynamic environment.
• Exceptional attention to detail, analytical and problem solving and critical thinking skills.
• Ability to influence others and work independently and in a team environment.
• Experience working closely with Manufacturing, CMC, Regulatory, Quality, Clinical teams, and logistics providers.

Preferred Qualifications

• Experience with cell and gene therapy supply chains highly preferred.
• Additional specific qualifications in clinical supply chain planning including APICS CPIM or CSCP, and related professional certifications.
• Solid understanding of regulatory requirements for clinical supplies with experience applying them to packaging/labeling and distribution operations.
• Strong user in data analytics tools and project planning tools.
• Knowledge of trade compliance and VAT/GST reclamation
• Knowledge of building and enhancing IRT systems

Competencies

• Collaborative – Openness, One Team
• Undaunted – Fearless, Can-do attitude
• Results Orientation – Delivering progress toward our mission. A 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. Certain lab based and manufacturing positions are located fully on-site.

Manager: Base pay range of $120,000 to $135,000+ bonus, equity and benefits

Senior Manager: Base pay range of $140,000 to $160,000+ bonus, equity and benefits

The range provided is CRISPR Therapeutics’ reasonable estimate of the base compensation for this role. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities.

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