Director, gRNA Process Development

The Position

As Director, gRNA Process Development you will have an integral role in Technical Operations contributing to development and clinical-stage manufacturing of Verve’s novel gene editing products. The ideal candidate will have experience with oligonucleotide process development, oligonucleotide synthesis, tech transfer, scale-up, and GMP manufacturing support. In this highly collaborative role, you will lead a gRNA process development team and contribute to advancing Verve’s manufacturing strategy for multiple programs at various stages of clinical development.

This is a hybrid role and requires 3-days in our Boston office.  We are considering local candidates at this time. 

Job Responsibilities

• Lead a gRNA process development team (including upstream and downstream functions) that is focused on optimization of long oligonucleotide GMP drug substance manufacturing processes.
• Support, mentor, and develop team members, providing timely and actionable feedback.
• Contribute to establishing a stage-appropriate process control strategy to support gRNA manufacture through clinical and commercial development.
• Refine the technical requirements for upstream and downstream tech transfer and process implementation at a GMP manufacturing facility, including equipment specifications, procedures, and recommended operating parameters/ranges.
• Support gRNA drug substance manufacturing for Verve’s clinical programs.
• Collaborate with cross-functional teams including Chemistry, Analytical Development, Formulation, Editing, Quality Control, Quality Affairs, and External Manufacturing.
• Write and/or provide technical review of documentation including process development reports, process descriptions, manufacturing batch records, campaign summary reports, etc.
• Contribute to global regulatory filings to support clinical development of Verve’s products.
• Other duties as assigned.

Qualifications

• Lead a gRNA process development team (including upstream and downstream functions) that is focused on optimization of long oligonucleotide GMP drug substance manufacturing processes.
• Support, mentor, and develop team members, providing timely and actionable feedback.
• Contribute to establishing a stage-appropriate process control strategy to support gRNA manufacture through clinical and commercial development.
• Refine the technical requirements for upstream and downstream tech transfer and process implementation at a GMP manufacturing facility, including equipment specifications, procedures, and recommended operating parameters/ranges.
• Support gRNA drug substance manufacturing for Verve’s clinical programs.
• Collaborate with cross-functional teams including Chemistry, Analytical Development, Formulation, Editing, Quality Control, Quality Affairs, and External Manufacturing.
• Write and/or provide technical review of documentation including process development reports, process descriptions, manufacturing batch records, campaign summary reports, etc.
• Contribute to global regulatory filings to support clinical development of Verve’s products.