Senior QC Analyst - 2285

What if you could repair broken genes? That is the question we ask ourselves at Editas Medicine. Were focused on translating the power and potential of the CRISPR/Cas9 and CRISPR/Cpf1 (also known as Cas12a) genome editing systems into a robust pipeline of medicines for people living with serious diseases around the world. Our goal is to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for many diseases. Were looking for talented, dedicated, passionate people to join our team and help us pioneer this field and do big, bold things that have never been achieved before. Are you full of hope, possibilities, and a belief that, working together, we can truly revolutionize the development of medicines to help patients around the world? If the answer is yes, then Editas Medicine is the place for you.

Editas is seeking a Quality Control Senior Analyst to join the Quality Control team and play a significant role in the support of our product pipeline, including, but not limited to EDIT-202 program.

Reporting to the QC Manager, Internal Operations, this position will be responsible for routine and non-routing QC testing and method transfer from Internal Analytic Development and/or External Testing Laboratories to Editas Quality Control at Editas Medicine as needed.

This position will work at both QC sites in Cambridge facility and Waltham facility, MA.

Key Responsibilities & Accountabilities:

• Perform routine/non-routine testing of in-process, final product, raw material samples in accordance with Standard Operating Procedures, such as Cell bank generation, Cell Count and Viability by Cellometer, Flow Cytometry using BD FACS Canto, Nucleic Acid quantitation by NanoDrop, and Bioassays by ELISA. Other required equipment and assay experience include pH/Conductivity, Colony Forming Assay, Visual Inspection, HPLC/UHPLC, ddPCR, ImageStream, Osmolality, Gel Electrophoresis, FTIR, and etc.
• Responsible for generation, revise and review of other protocols, procedures (e.g. SOPs, Test Methods, FORMS) and report, as required.
• Responsible for change controls, OOS and deviations, as required.
• Communicates with internal analysts in QC and different departments in Editas, and with external contract testing laboratories for technical issues and make sound judgment and decision for problem solving.
• Responsible for drafting, executing and reporting Method Transfer Protocols as needed.
• Perform other duties, as assigned.

Requirements

Knowledge, Experience, Skills & Capabilities:

• Hands-on experience on following equipment/assays: Cell culture, Flow cytometery, Cellometer K2, NanoDrop, Plate Reader, HPLC/UHPLC, ddPCR, pH meter, Osmometer, FTIR, ImageStream, StemVision, EnVision, Visual Appearance Inspection.
• Working experience on method transfer.
• Working experience in analytical/QC environment.
• Working experience in compliance with cGMPs, effectively demonstrates an understanding of cGMP's and how it applies to specific responsibilities.
• Ability to work independently with skills for multi tests/projects.
• Ability to collaborate, communicate, and work effectively in a team-oriented.
• Good verbal and written communication skills.
• Proficiency in the use of Microsoft Office (Word, Excel, PowerPoint, etc), electronic documentation and Training systems.

Education & Relevant Work Experience:

• Bachelors or Masters degree in biology, chemistry or other life science.
• At least 5-8 years of relevant industry experience in Analytical/Quality Control in a Pharmaceutical/Biotech GMP environment. Working experience in the fields of gene and cell therapies is a plus.
• Authorization to work in the United States indefinitely without restriction or sponsorship.

Recommended Skills

• Analytical
• Biochemical Assays
• Biology
• Biotechnology
• Cell Cultures
• Certified Global Meeting Planner