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Clinical Product Logistics Manager

If interested and qualified, please include Requisition # 2018-314 in the subject line when emailing resume to: careers@crisprtx.com.

For more information on CRISPR Therapeutics, please click here.

Position Summary

Reporting to the Head of Supply Chain, the Clinical Product Logistics Manager will manage clinical product logistics activities for our upcoming clinical trials, beginning with autologous cell therapies. In this highly visible role, the successful candidate will join the existing clinical trial team to coordinate activities across our clinical sites, couriers, and manufacturing partners 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 clinical sites.

Responsibilities

  • Lead day to day support of clinical supply operations, 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
  • Coordinate with clinical site study coordinators, cell collection centers, cell therapy manufacturing sites and internal stakeholders to ensure subject schedules are maintained within the process and logistic constraints
  • 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 cell collections and drug product delivery 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 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 Supply Chain with ad-hoc tasks as required

Minimum Qualifications

  • 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

Preferred Qualifications

  • Experience with cold chain and autologous cell therapies highly preferred
  • 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

Competencies

  • Perseverance – Pursues tasks with energy, drive and initiative, even in the face of adversity.
  • Results Oriented – Drives issues to closure and gets the job done.
  • Effective Planning - Embedding discipline and thoroughness in our approaches.
  • Adaptability/Flexibility - The ability to adapt to working effectively within a variety of situations; adapts enthusiastically to organizational change and to changes in job demands.
  • Problem Solving – The ability to understand a situation, task or problem by breaking it down into smaller pieces using a systematic approach and to identify patterns and connections between situations that are not obviously related.
  • Relationship Building – Builds and maintains productive working relationships across a diverse spectrum of people.

If interested and qualified, please include Requisition # 2018-314 in the subject line when emailing resume to: careers@crisprtx.com.

For more information on CRISPR Therapeutics, please click here.