Senior Scientist, LNP MSAT

CRISPR Therapeutics•South Boston, MA

4d•$137,000•Hybrid

About The Position

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 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 If you enjoy challenges, are eager to learn, and want to join a team working on the next generation of gene editing therapeutics, we'd love to hear from you. Our ideal candidate will possess practical experience in tech transfer and large-scale LNP manufacturing, along with a strong understanding of process engineering principles.

Requirements

Ph.D. in biology, bioengineering, chemical engineering, or a related discipline, and 5-7+ years of professional experience or bachelor’s degree with 10+ years of professional experience
Outstanding problem-solving skills and a willingness to think outside the box.
Prior experience with gene editing and manufacturing of lipid nanoparticles (LNPs).
Expertise in manufacturing, tech transfers, and deviations.
Excellent writing, reviewing, and presentation skills.
Thorough knowledge of cGMP, ISO, and ICH guidelines and industry best practices.
Ability to work independently and collaboratively in a results-oriented environment.
Must possess critical thinking and self-reliance to solve tasks independently.

Nice To Haves

Self-motivated and scientifically rigorous, with outstanding organizational and multitasking skills.
Entrepreneurial spirit, including resourcefulness, accountability, agility to pivot, transparency, and productivity.
Ability to keep pace with a fast-moving organization

Responsibilities

Support the manufacturing operation at the CDMO
Manage, support, and lead the technology transfer of products into manufacturing facilities
Troubleshoot manufacturing events, perform root cause analysis, and implement corrective actions for process deviations
Analyze process data, monitor process performance against metrics, and present experimental or manufacturing data to a wide range of audiences
Collaborate with QA, QC, PD, AD, RA, and other teams to ensure operations are compliant
Generate, manage, evaluate, and maintain critical data in a highly organized manner, providing statistical analysis and troubleshooting where appropriate
Work closely with CDMO partners, providing technical oversight and taking the lead in supporting investigations and resolving deviations
Author and review technical sections for regulatory submissions
Analyze process and manufacturing data to understand and optimize process performance
Author and review technical reports and master and executed batch records, working across internal teams and with CDMO partners
Build strong, effective relationships with colleagues across diverse backgrounds and areas of expertise
Excellent interpersonal and communication skills; collaborative, solutions-oriented, and willing to contribute where needed