Stability Specialist

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

Reporting into the Senior Manager, External Quality Control & Stability, the Stability Specialist will support our stability program and conduct critical data reviews. This is a cross-functional and highly visible position within the Technical Operations group. The Stability Specialist will have the opportunity to actively collaborate with Research, Process Development, Quality teams, Regulatory and our CDMOs.

Responsibilities

• Monitor stability program for upcoming sample testing, manage testing schedules and disposition of material in support of testing, and ensure results are delivered from the testing labs
• Perform Data Review for integrity and accuracy and collate data in a highly organized manner
• Use statistical software to analyze the data for shelf-life and control chart trending
• Author new or revise existing shelf-life reports with available data in support of shelf-life extension
• Review CDMO stability protocols and author/review internal stability protocols.
• Conduct and document OOS and lab investigations and CAPA management including Change Controls required to facilitate shelf-life updates
• Author new or revise existing SOPs in support of stability system management as needed

Minimum Qualifications

• BS with 3-5+ years of relevant experience in industry,
• Experience in data review, organization, and analysis using statistical software.
• Experience in organizing detailed documentation and reporting to the stakeholders.
• Possess good GMP and GDP skills and has experience using Quality Systems.
• Good knowledge of QA compliance skills (auditing, lab investigation)
• Experience in routine PCR, SDS PAGE, and Bioassays
• Excellent organization skills, able to multi-task in a fast-paced environment with changing priorities. Must be able to work effectively as part of a multi-disciplinary team.
• Track record of completing deliverables within specified timelines and “do-what-it-takes” attitude.
• Superb communication skills—both written and oral.
• Independently motivated, detail oriented and good problem-solving ability.

Preferred Qualifications

• Understanding of statistical tools, such as SPSS, JMP, DoE, Prism etc. will be a plus.

Competencies

• 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 believes in fostering a dynamic workplace that balances remote work flexibility with the benefits of in-person interactions. Our employees work at least three days on-site, creating a collaborative work environment, where we cultivate mentorship opportunities, increase cross-functional communication and offer opportunities for our employees to connect.