Quality Control Analyst, Bioassay

Company Overview
CRISPR Therapeutics is a leading gene editing company focused on developing transformative gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 platform. CRISPR/Cas9 is a revolutionary gene editing technology that allows for precise, directed changes to genomic DNA. CRISPR Therapeutics has established a portfolio of therapeutic programs across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine and rare diseases. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Bayer, Vertex Pharmaceuticals and ViaCyte, Inc. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations in Boston, Massachusetts and San Francisco, California, and business offices in London, United Kingdom.
Position Summary
Our QC team is looking for an enthusiastic individual to work at our state-of-the-art manufacturing facility in Framingham, MA. This position will require initial training at CRISPR Cambridge site. QC Analyst is a valuable member of the Quality Control-Bioanalytical team that will coordinate and perform in-process and final product testing of novel cell-based drug therapies and AAV products. The successful candidate will perform a variety of bioassays in a GMP environment. In addition, the QC Analyst will lead analytical method transfer and validation projects.
Responsibilities

• Assist with the data review for compliance and product release, and generation of product COAs.
• Performs routine in-process and final release testing of cell therapies and AAV products.
• Support the transfer and validation of analytical methods to the Framingham facility.
• Complete and compiles all documentation and perform data review for compliance and product release.
• Assists in the implementation of the Laboratory Information Management System.
• Contribute to establish a reference standard program and sample management system.
• Author ad review SOPs, protocols, and reports.
• Conduct raw material qualification per approved SOPs.
• Assemble raw material data packages for release.
• Perform other related duties based on business needs.
• Support QC investigations, OOS, deviations, and CAPA implementation.
• Perform maintenance of QC equipment.

Minimum Qualifications

• Good at managing time and priorities.
• Minimum of bachelor’s degree in biochemistry or related scientific field with at least two years of relevant experience.
• Experience with bioassays, preferable in a QC environment.
• Experience with cell culture and aseptic techniques
• Hands-on experience with molecular and cell biology techniques such as flow cytometry, PCR, and ELISA/Multiplex.
• Excellent communication skills, technical writing, and detail oriented.

Preferred Qualifications

• Experience with cell culture and aseptic techniques
• Direct experience with analytical method validations and/or transfers

Competencies

• Entrepreneurial Spirit – Proactive. Ownership mindset.
• Collaborative – Openness, One Team
• Undaunted – Fearless, Can-do attitude
• Results Orientation – Delivering progress toward our mission. Sense of urgency in solving problems.

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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