Senior Scientist, LNP MSAT

Job Description:

Company Overview

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.

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

Minimum Qualifications

• 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.

Preferred Qualifications

• 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

Competencies

• Collaborative – Openness, One Team
• Undaunted – Fearless, Can-do attitude
• Results Orientation – Delivering progress toward our mission. Sense of urgency in solving problems.
• Entrepreneurial Spirit – Proactive. Ownership mindset.

CRISPR Therapeutics believes in fostering a dynamic workplace that balances remote work flexibility with the benefits of in-person interactions. Our employees work at least three days on-site, creating a collaborative work environment, where we cultivate mentorship opportunities, increase cross-functional communication and offer opportunities for our employees to connect. Certain lab based and manufacturing positions are located fully on-site.

Senior Manager: Base pay range of $137,000 to $150,000+ bonus, equity and benefits

The range provided is CRISPR Therapeutics’ reasonable estimate of the base compensation for this role. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities.

CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.

To view our Privacy Statement, please click the following link: http://www.crisprtx.com/about-us/privacy-policy