Clinical Supply Chain Manager
Reporting to the Head of Product and Supply Management, the Clinical Supply Chain Manager will manage clinical supply planning and logistics activities for our upcoming clinical trials, focusing on our allogeneic programs. In this highly visible role, the successful candidate will join the existing team to coordinate activities across our manufacturing sites, label and distribution vendors, and other key stakeholders to deliver our products. The position requires enthusiasm, passion, attention to detail and a desire to create new medicines for patients. This position will require up to 20% travel to assist in training and managing activities across the supply chain sites.
- Lead day to day support of clinical supply operations for allogeneic trials, including scheduling, tracking and managing clinical product 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 clinical trials
- Generate and maintain clinical supply plans and forecast future demand to drive manufacturing, labeling, and overall 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, Manufacturing, Quality, and CMOs along with other service providers to ensure seamless operation of clinical trials and address any challenges
- Review study timelines and upcoming demand for drug product to ensure alignment with internal and external stakeholders
- Create and maintain planning and logistics metrics to enable process improvements
- 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 implement solutions to meet timelines
- Responsible for product traceability and chain of custody between clinical and manufacturing sites.
- 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 to the Head of Product and Supply Management with ad-hoc tasks as required.
- BS in Biological Sciences or related fields
- 3-5 years’ experience working within a cGMP supply chain environment and/or with GCP regulations
- Excellent computer skills (Microsoft Office Word, Excel, Outlook) required
- Willingness to work in a flexible environment
- Must be willing to travel domestically and internationally up to 20%
- Excellent organizational skills, sufficient 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
- Pharmaceutical/biotech experience, additional experience with cell and gene therapies highly preferred.
- Experience with cold chain shipments and managing clinical supplies with IXRS
- Additional specific qualifications in the area of clinical supplies logistics or planning management including APICS CPIM, and related professional certifications
- Excellent interpersonal, verbal, and written communication skills
- 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, 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.