Senior Scientist, LNP MSAT
CRISPR Therapeutics
4 months ago
Remote friendly (Boston, MA)
United States
$137,000 - $150,000 USD yearly
Operations
Responsibilities:
- Support the manufacturing operation at the CDMO
- Manage, support, and lead 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/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 an organized manner, including statistical analysis and troubleshooting
- Work closely with CDMO partners to provide technical oversight and lead investigations and deviation resolution
- 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/executed batch records with internal teams and CDMO partners
- Build strong relationships with colleagues across diverse backgrounds
- Provide excellent interpersonal and communication skills; collaborative, solutions-oriented, and willing to contribute
Minimum Qualifications:
- Ph.D. in biology, bioengineering, chemical engineering, or related discipline with 5–7+ years’ experience, or Bachelor’s degree with 10+ years’ experience
- Prior experience with gene editing and manufacturing of lipid nanoparticles (LNPs)
- Expertise in manufacturing, tech transfers, and deviations
- Thorough knowledge of cGMP, ISO, and ICH guidelines and industry best practices
- Excellent writing, reviewing, and presentation skills
- Outstanding problem-solving skills; willingness to think outside the box
- Ability to work independently and collaboratively in a results-oriented environment
Preferred Qualifications:
- Self-motivated and scientifically rigorous; strong organizational and multitasking skills
- Entrepreneurial spirit (resourcefulness, accountability, agility to pivot, transparency, productivity)
- Ability to keep pace with a fast-moving organization
Benefits / Compensation:
- Senior Scientist: Base pay range of $137,000 to $150,000+ bonus, equity and benefits
- Support the manufacturing operation at the CDMO
- Manage, support, and lead 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/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 an organized manner, including statistical analysis and troubleshooting
- Work closely with CDMO partners to provide technical oversight and lead investigations and deviation resolution
- 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/executed batch records with internal teams and CDMO partners
- Build strong relationships with colleagues across diverse backgrounds
- Provide excellent interpersonal and communication skills; collaborative, solutions-oriented, and willing to contribute
Minimum Qualifications:
- Ph.D. in biology, bioengineering, chemical engineering, or related discipline with 5–7+ years’ experience, or Bachelor’s degree with 10+ years’ experience
- Prior experience with gene editing and manufacturing of lipid nanoparticles (LNPs)
- Expertise in manufacturing, tech transfers, and deviations
- Thorough knowledge of cGMP, ISO, and ICH guidelines and industry best practices
- Excellent writing, reviewing, and presentation skills
- Outstanding problem-solving skills; willingness to think outside the box
- Ability to work independently and collaboratively in a results-oriented environment
Preferred Qualifications:
- Self-motivated and scientifically rigorous; strong organizational and multitasking skills
- Entrepreneurial spirit (resourcefulness, accountability, agility to pivot, transparency, productivity)
- Ability to keep pace with a fast-moving organization
Benefits / Compensation:
- Senior Scientist: Base pay range of $137,000 to $150,000+ bonus, equity and benefits