Job Title: Senior Scientist III Analytical Development
Job Overview
The primary function of this role is to oversee the development and implementation of analytical methods, both internally and through external partnerships, to support the characterization, release testing, and stability of CRISPR-based drug substance and product.
Key Responsibilities
* Develop and execute strategies for analytical method development and implementation in both internal R&D labs and contract testing facilities.
* Establish and maintain relationships with external partners, including contract testing laboratories and manufacturing organizations, to ensure seamless method development, validation, and transfer.
* Provide technical leadership on assay design and analytical strategy, ensuring methods are scalable, phase-appropriate, and tailored for novel CRISPR-based genetic medicines.
* Support the preparation of critical documentation for regulatory submissions, including INDs.
* Evaluate and implement emerging analytical technologies that align with the ultracompact CRISPR platform and pipeline needs.
Requirements
* Ph.D. or equivalent degree in a relevant scientific discipline.
* Minimum 5 years of experience in analytical development, with a strong background in method development, validation, and transfer.
* Proven track record of successful collaborations with external partners, including contract testing laboratories and manufacturing organizations.
* Strong understanding of regulatory requirements, including ICH guidelines.
* Excellent communication and project management skills.