Senior Quality Control Stability Specialist

2 months ago

Boston, United States CRISPR Therapeutics Full time

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 to the Senior Manager, External Quality Control & Stability, the Senior Quality Control Stability Specialist works cross-functionally in a highly visible position across the Technical Operations group. They will actively collaborate with research, process development, quality teams, regulatory and CDMOs to ensure a compliant stability program in addition to providing Quality Control support to ongoing CRISPR Tx programs.

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 Support data review of cell therapies, AAV products, and Critical Components Maintains completed stability data tables and assesses data trending utilizing applicable statistical software. Review CDMO stability protocols and author/review internal stability protocols Support regulatory filing with stability data tables and trending, as needed Support the transfer and validation of analytical methodology Write and/or revise SOPs and reports Support QC investigations, OOS, deviations, and CAPA implementation Perform other related duties based on business needs including project team representation

Minimum Qualifications

Bachelor’s degree in a relevant scientific area, with at least five years in QC/Analytical testing Hands-on experience with flow cytometry, PCR, or ELISA/Multiplex Understanding of ICH Stability guidelines Good knowledge of QA compliance skills Experience in data review, organization, and analysis using statistical software Excellent communication skills, technical writing, and attention to detail 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.

Preferred Qualifications

Experience with cell and gene therapies

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.

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.

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