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
Reporting to the Head of Clinical Supply Chain, the Associate Director of Clinical Supply Planning will focus on managing and optimizing global supplies to ensure timely availability of clinical supplies for clinical trials. This is a critical role that will also be involved in setting up a robust clinical supply planning model to support clinical trials, ensuring alignment with company goals. This position will lead the establishment of an S&OP process, deliver optimized long-range capacity plans and develop optimum inventory policies, and support packaging and labeling activities. 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 position requires enthusiasm, passion, attention to detail and a desire to create new medicines for patients.
Responsibilities
- Accountable for generating and maintaining 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).
- Plans and oversees 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
- Bachelors 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.
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