Manager, Infusion Support Operations jobs in United States
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CRISPR Therapeutics · 2 hours ago

Manager, Infusion Support Operations

CRISPR Therapeutics is a pioneering company in gene editing with a diverse portfolio of product candidates. The Manager, Infusion Support Operations will provide technical and clinical support during clinical trials and infusion activities, ensuring successful protocol execution and training for clinical trial site teams.

BiopharmaBiotechnologyGeneticsMedical
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H1B Sponsor Likelynote

Responsibilities

Participate in the design and implementation of successful infusion protocols, cross functional SOPs, and scientific training material 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 ensure successful translation of the clinical protocol into operational deliverables, and participate in the design and development of 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 related to CRISPR Therapeutics drug products and collaborate with clinical infusion sites to ensure subject safety, adherence to GCP, GxP, GDP and compliance with study protocol
Assess and document the effectiveness of education provided to clinical sites, including the activation of new sites to the clinical trial
Participate in study site selection by evaluating a site’s ability to comply with CRISPR Therapeutics requirements for receipt, storage, thaw, and infusion procedures
Provide continuous on-site or remote support for all drug product programs which includes working outside of normal business hours, (i.e. nights, weekends and holidays)
Work with cross-functional team to identify opportunities to improve processes and products, including apheresis, as needed by GMP manufacturing; this may include updates to vendor procedures or processes and supporting change documentation by CRISPR

Qualification

Clinical experienceRegulatory requirementsInfusion proceduresAnalytical skillsTechnical supportResults orientationEntrepreneurial spiritMS OfficeCommunication skillsCollaborative

Required

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

Preferred

Experience with infusion procedures
Experience with clinical education

Benefits

Bonus
Equity
Benefits

Company

CRISPR Therapeutics

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CRISPR Therapeutics is focused on the development of transformative medicines using its proprietary CRISPR/Cas9 gene-editing platform.

H1B Sponsorship

CRISPR Therapeutics has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (18)
2024 (25)
2023 (16)
2022 (18)
2021 (13)
2020 (16)

Funding

Current Stage
Public Company
Total Funding
$407M
Key Investors
EcoR1 CapitalBill & Melinda Gates FoundationFranklin Templeton,New Leaf Venture Partners
2024-02-13Post Ipo Equity· $280M
2020-12-14Grant
2016-10-19IPO

Leadership Team

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Raju Prasad
Chief Financial Officer
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Naimish Patel
Chief Medical Officer
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Company data provided by crunchbase