Manager, Infusion Support Operations

Overview

Job Description: CRISPR Therapeutics is a leading gene editing company focused on developing therapeutics across a range of disease areas. This description reflects a general overview of the role and company context as part of the infusion support operations function.

Company Overview

CRISPR Therapeutics has transformed from a research-stage company into a multi-program biotechnology company with a broad portfolio of product candidates in hemoglobino pathies, oncology, regenerative medicine, cardiovascular and rare diseases. The company collaborates with leading industry partners and operates globally with headquarters in Zug, Switzerland, a wholly-owned U.S. subsidiary, and R&D sites in Boston, MA, and San Francisco, CA.

Position Summary

Reporting to the Vice President, AID Program Leader and Head of Translational Medicine, the Manager, Infusion Support Operations provides technical and clinical support during clinical trials and infusion-related activities. This role works on cross-functional study teams for clinical trial execution, data interpretation, and cross-functional communication. The Manager interfaces with Clinical Operations, Technical Operations, Quality, Regulatory Affairs, and other functions as needed.

The Manager, Infusion Support Operations does not provide direct patient care but will train, support, and educate clinical trial site teams on CRISPR drug product handling, storage, administration, and monitoring.

The Manager will be available to support stem cell laboratory personnel, the cell therapy transplant team, and the clinical research team on infusion-related activities.

• Participate in the design and implementation of infusion protocols, cross-functional SOPs, and scientific training materials to support clinical trials. Develop infusion and protocol training materials to support internal and external activities.
• Collaborate with internal stakeholders (clinical operations, data management, statistics, safety, regulatory affairs, etc.) to translate clinical protocols into operational deliverables and participate in shared process improvement programs.
• Collaborate with analytical laboratory personnel to assist with drug product thaw and infusion process testing.
• Train clinical sites on receipt, storage, thaw, and infusion procedures for CRISPR Therapeutics drug products and work with sites to ensure subject safety and compliance with GCP, GxP, GDP and study protocol.
• Assess and document the effectiveness of education provided to clinical sites, including activation of new sites to the trial.
• Participate in study site selection by evaluating a site’s ability to comply with company requirements for receipt, storage, thaw, and infusion procedures.
• Provide continuous on-site or remote support for all drug product programs, including after-hours availability (nights, weekends, holidays).
• Identify opportunities to improve processes and products (e.g., apheresis) as needed by GMP manufacturing, including updates to vendor procedures or change documentation.

• Advanced degree in a scientific discipline such as RN with 5-7+ years of clinical experience (preferably in hospital inpatient or pharmacy settings) or Pharm
  
  D/PhD with 1-3+ years of clinical experience (preferably in hospital inpatient or pharmacy settings).
• Excellent oral and written communication skills.
• Experience with MS PowerPoint, Word, Excel, Teams, SharePoint, and Zoom.
• Ability to work collaboratively in a fast-paced, team-based matrix environment.
• Thorough understanding of ICH, GCP, GDP and relevant regulatory requirements.
• Strong analytical and strategic thinking skills with experience interacting with medical monitors, development operations, regulatory affairs, Quality Assurance, and clinical investigators.

• Experience with infusion procedures.
• Experience with clinical education.

• Collaborative – Openness, One Team
• Undaunted – Fearless, Can-do attitude
• Results Orientation – Delivering progress toward our mission, sense of urgency
• Entrepreneurial Spirit – Proactive, ownership mindset

CRISPR Therapeutics supports a dynamic workplace with remote flexibility and on-site collaboration. Our roles require in-person work components where applicable; certain lab-based and manufacturing positions are located fully on-site.

Base pay range of $118,000 to $130,000 plus bonus, equity and benefits. The range is a reasonable estimate of base compensation and may vary based on experience, training, skills, and abilities.

CRISPR Therapeutics, Inc. is an equal employment opportunity employer and does not discriminate on the basis of race, color, gender, age, religion, national origin, disability, veteran status, genetic information, sexual orientation, or any other characteristic protected by law.

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