Clinical Supply Chain Planning Director

4 weeks ago

Boston, Massachusetts, United States CRISPR Therapeutics Full time
Job Description

Company Overview

CRISPR Therapeutics is a pioneering biotechnology company that has revolutionized the field of gene editing. With a diverse portfolio of product candidates across various disease areas, the company is committed to creating a new class of transformative medicines. As a leader in the industry, CRISPR Therapeutics has established strategic partnerships with leading companies and has a strong presence in Zug, Switzerland, with subsidiaries in the US, UK, and other locations.

Position Summary

The Associate Director of Clinical Supply Chain will play a critical role in managing and optimizing global supplies to ensure timely availability of clinical supplies for clinical trials. This position will lead the establishment of a robust clinical supply planning model, develop and maintain strong collaborative relationships with team members, and drive the creation of a seamless clinical trial operation.

Responsibilities

  • Develop and maintain a clinical supply plan to drive manufacturing, labeling, and forecasting supply activities across internal and external stakeholders.
  • Lead and manage the supply planning for finished goods, drug product, drug substance, and critical components across multiple clinical programs.
  • Collaborate with clinical teams and other internal/external stakeholders to forecast demand based on trial protocols and timelines.
  • Coordinate with manufacturing sites, clinical sites, and label/storage/distribution vendors and other internal stakeholders to ensure consistent inventory is available at each node to sustain the clinical trial(s).
  • Plan and oversee packaging and labeling operations both internally and with CMOs as required to support the clinical supply plan.
  • Define and implement KPIs/metrics related to supply and demand.
  • Work closely and proactively with internal/external stakeholders to ensure seamless operation of clinical trials and address any challenges.
  • Participate/lead investigations in close collaboration with Quality, as applicable.
  • Identify issues and/or risks with meeting clinical supply requirements and suggest solutions to meet timelines.
  • Continuously evaluate and improve supply chain planning business processes to optimize operations.
  • Consistently perform duties within established SOPs, and in accordance with GXP requirements.

Minimum Qualifications

  • Bachelor's degree in Biological Sciences or related fields.
  • 10-12+ years' experience working within a cGMP supply chain environment and/or with GCP regulations.
  • Excellent computer skills (Microsoft Office Word, Excel, Outlook) required.
  • Experience with clinical supply chain planning.
  • Willingness to work in a flexible environment.
  • Excellent organizational skills, enough to multi-task in an extremely fast-paced environment with changing priorities while maintaining attention to detail.
  • Clear and succinct verbal and written communication skills.
  • Strong analytical, problem-solving, and critical thinking skills.
  • Ability to influence others and work independently and in a team environment.
  • Experience working closely with Manufacturing, Project Management, functional team leaders, clinical teams, contract manufacturing partners, and/or cold chain shippers and logistics providers.

Preferred Qualifications

  • Experience with cold chain, and cell and gene therapies highly preferred.
  • Additional specific qualifications in the area of clinical supply chain planning including APICS CPIM or CSCP, and related professional certifications.
  • Excellent interpersonal, verbal, and written communication skills.

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.

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

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