Manager, Clinical Supply Chain Logistics

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 

The Manager, Clinical Supply Chain Logistics will manage logistics activities for GMP operations and our upcoming clinical trials. In this highly visible role, the successful candidate will join the Clinical Supply Chain team to coordinate activities across our manufacturing sites, contract test labs, label and distribution vendors, and other key stakeholders to ensure samples, starting materials, and our products are monitored and delivered on time to support company objectives. The position requires enthusiasm, passion, attention to detail and a desire to create new medicines for patients. 

Responsibilities 

• Lead day to day support of clinical supply operations for all clinical trials, including scheduling, tracking, and managing clinical product logistics and performing quality checks across the supply chain to ensure compliance. 
• Lead day to day support of logistic operations supporting material movement for critical components, samples, and other materials to support GMP operations, including scheduling, tracking, and managing logistics and performing quality checks across the supply chain to ensure compliance. 
• Act as a first line resource to manage the interface between functions pertaining to supply, transportation, logistics, and traceability issues for the materials moved 
• Support a clinical supply plan to drive manufacturing, labeling, and forecasting supply activities across internal and external stakeholders 
• 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) 
• Work closely with Clinical Operations, Internal & External Manufacturing and MSAT, Quality Control, Quality, and CMOs along with other service providers to ensure seamless operation of clinical trials, sample and material shipments and address any challenges 
• Review study timelines and upcoming demand for drug product to ensure alignment with internal and external stakeholders 
• May be required to participate / lead investigations into exceptions in labeling, storage, and logistics activities in close collaboration with Quality 

• Identify issues and/or risks with meeting clinical supply requirements and suggest solutions to meet timelines 
• Responsible for product traceability and chain of custody between manufacturing sites and the clinics. 
• Develop and maintain materials for sites to ensure effective product handling (e.g., manuals, visual work instructions, information sheets, checklists, and other documents). 
• Consistently perform duties within established SOPs, and in accordance with GXP requirements. 
• Provide support for the Clinical Supply Chain team with ad-hoc tasks and cross-train and back up team members as required. 
• Build out annual budget, initiate purchase orders, approve invoices, track spend and be accountable to the logistics spend vs. budget 

Minimum Qualifications 

• Bachelors in Biological Sciences or related fields 
• 6-8+ years’ experience working within a cGMP supply chain environment and/or with GCP regulations 
• Excellent computer skills (Microsoft Office Word, Excel, Outlook, Smartsheets) required 
• 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 manuf