Sr. Associate Scientist/Scientist I, QC

Job Title: Sr. Associate Scientist/Scientist I, QC

Job Number: 84290

Location: , US

Job Description

We are currently seeking a talented and motivated Scientist to join the analytical development and QC testing team in Prime’s Technical Development and Operations Division. This individual will perform and manage QC testing, critical reagents, and stability protocols for drug substances and drug products at Prime Medicine. The Quality Control Scientist will be responsible for optimization, qualification, transfer, verification, and QC implementation of methods associated with cGMP production of cell and gene therapy drug products and gene editing components.  This individual will collaborate with Prime’s Analytical Development team and external partner representatives (CTL/CDMO) on test methods to support testing of cell and gene therapy products; writing protocols, test methods; overseeing and/or participating in execution of method lifecycle activities.  This is a hands-on role where the successful candidate will be involved in day-to-day laboratory activities. The ideal candidate will work under limited supervision and will excel in a matrixed environment, as this role will interface with the quality teams, informatics team, process development, formulation, and research teams to advance the Prime Editing therapeutic product pipeline, with a focus on later stage product candidates.   This position offers significant opportunities for professional growth in a fast-paced biotech environment which includes moving prime editing therapeutics into clinical development and collaborating with world-class researchers.

Responsibilities

* Perform QC testing of drug products and substances using USP and other methods   * Conduct data analysis, maintain GxP-compliant documentation * Collaborate with process development and research, and conduct non-GMP sample testing * Support method tech-transfer, oversight, and troubleshooting with CTL/CDMOs * Develop and qualify QC test methods, and participate in method validation and performance monitoring * Manage reference standards, reagents, and inventory; assist with stability data analysis * Ensure data integrity and regulatory compliance * Author and review protocols, SOPs, and technical documents * Support QC equipment installation and qualification, ensuring 21 CFR Part 11 compliance * Maintain electronic lab notebooks and present findings to teams

Required Skills

* BS/MS in Biology, Chemical Engineering, Bioengineering, or related field.   * 5-7 years’ experience for BS, 3-5 years for MS. * Passion for gene editing therapies and commitment to team success. * Experience in assay development, qualification, and QC testing. * Knowledge of analytical methods including chromatography, plate-based assays, sequencing, and flow cytometry. * Experience with cell and gene therapies and assay validation preferred. * Familiarity with ICH/FDA guidelines and CMO/CDMO management is a plus. * Self-motivated with a proactive attitude and strong project ownership. * Collaborative with cross-functional teams and external partners. * Good communication, interpersonal, and negotiation skills. * Adaptable, organized, and detail-oriented in a fast-paced environment.

Application Deadline: 2024-11-04