Senior Scientist, LNP MSAT

CRISPR Therapeutics • Boston, MA

4d • $137,000 - $150,000 • Hybrid

About The Position

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

Benefits

• Base pay range of $137,000 to $150,000+ bonus, equity and benefits
• balances remote work flexibility with the benefits of in-person interactions
• cultivate mentorship opportunities, increase cross-functional communication and offer opportunities for our employees to connect

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree
• Number of Employees: 251-500 employees