Senior/Principal Scientist, CMC Process Development and Manufacturing

We are looking for a passionate Senior/Principal Scientist CMC Process Development and Manufacturing who will lead drug substance process development projects for our programs at different stages, with a focus on process development and process characterization for oligonucleotides with novel chemical modifications.

Requirements

• Lead process development projects including oligonucleotide synthesis activities, process development, optimization and scale-up, and process characterizations.
• Collaborate with Drug Substance, Drug Product and Quality Assurance to ensure strong cross functional collaborations and serve the PD/Mfg functional line to ensure that the team meets technical project timelines and milestones.
• Communicate relevant information and results to CMC team as well as other key stakeholders throughout the City Therapeutics organization.
• Author and review DS/DP documentation including, but not limited to, process development reports, master and executed batch records, release and stability testing reports.
• Build and maintain strong relationships with internal and external partners Contract Manufacturing Organizations (CMOs), analytical labs, and CMC advisors to ensure successful process and analytical strategies and executions
• Author and review high-quality CMC packages for submissions that meet or exceed the expectations of external regulators and lead to first-cycle approvals.

Benefits

• Medical, dental, vision, life insurance
• Health and dependent care FSA accounts
• HSA/HRA accounts with company contributions
• 401(k) with competitive company match