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Clinical Supply Chain Planning Director
hace 1 mes
Company Overview: CRISPR Therapeutics is a pioneering biotechnology company that has transformed the field of gene editing. With a diverse portfolio of product candidates across various disease areas, we are committed to creating a new class of transformative medicines.
Position Summary:
We are seeking an experienced Associate Director to lead our Clinical Supply Chain Planning team. As a key member of our supply chain organization, you will be responsible for managing and optimizing global supplies to ensure timely availability of clinical supplies for clinical trials. This critical role will also involve setting up a robust clinical supply planning model to support clinical trials, ensuring alignment with company goals.
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.
Requirements:
- 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.
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 is an equal employment opportunity and non-discrimination employer 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.
