Scientist, Process Sciences

Role Summary

The Scientist, Process Sciences will be a member of the Process Transfer team, focusing on drug substances, including process transfer to external and internal CMOs, process development, support of non-GMP manufacturing, and early stage GMP manufacturing of oligonucleotide-based APIs. This onsite role is based at our Kendall Square office in Cambridge, MA.

Responsibilities

• Contribute to process development and optimization of oligonucleotide manufacturing process and technology transfer projects.
• Manage in-process analytical method development and utilization.
• Work closely with cross-functional teams (R&D, Quality, Analytical Development, Supply Chain) to ensure seamless coordination and successful execution of manufacturing projects.
• Provide technical support for GMP manufacturing, including process fit assessment, batch record review, and process excursions.
• Authoring and reviewing technical protocols and reports in support of manufacturing process development.
• Authoring, review, and approval of technical documentation, including process development reports, process flow descriptions, campaign summary reports, batch records, change controls, SOPs, and data verification, ensuring compliance with internal procedures.
• Communication of relevant information and results to CMC development team as well as other key stakeholders throughout the organization.

Qualifications

• Ph.D. in Organic Chemistry or Chemical Engineering with minimum of 2 years of experience in industrial settings preferred.
• Expertise and experience in solid phase synthesis of oligonucleotides, oligonucleotide-conjugates or comparable biopolymers is a plus.
• Thorough understanding of the analytical and purification techniques for oligonucleotides, and oligonucleotide-conjugates (with lipids, peptides, and small molecules) used in characterization of oligonucleotides.
• Direct experience with using and troubleshooting DNA/RNA automated solid-phase synthesizers is preferred.
• Proficiency in authoring, reviewing and execution of manufacturing and process development documentation.
• Ability to integrate scientific principles/findings/results across multiple research areas.
• Experience with statistical design of experiments (DOE), good verbal and written communication.