Lead Development Engineer, Drug Substance

Summary

Join a pharmaceutical company dedicated to improving the lives of people with neurodegenerative diseases as a Head of CMC, Peptides and Oligonucleotides.

Requirements

• Bachelor’s degree in biology, chemistry, chemical engineering, or related field. MS or PhD preferred
• At least 15 years of experience in technical development including prior oligonucleotide and/or peptide process development within the pharmaceutical industry
• Experience leading global, cross-functional, high performing teams. Prior experience leading or serving on a CMC team preferred
• Advanced knowledge of cGMP/GLP regulations, ICH, FDA CMC Guidance Documents
• A strong track record of successful global CMC submissions and approvals
• Must be able to function independently and influence appropriate stakeholders and recommend scientifically rigorous, phase appropriate, risk-management based solutions to complex technical challenges
• Experience working with contract manufacturing organizations
• Excellent communication and teamwork skills

Responsibilities

• Lead CMC teams to identify and prioritize development activities
• Serve as the technical SME and process owner for drug substance
• Author IND and NDA Module 3, Master Batch Records, Validation Plans and Reports
• Ensure robust regulatory plans for all changes while minimizing risk to product supply
• Foster effective teamwork and drive project execution
• Proactively track critical path activities, anticipate risks, create contingency plans and decision-making exercises in collaboration with project teams
• Update project timelines and budgets, communicate progress, and maintain the CMC program plan
• Regularly interacts with functional areas including Regulatory, Quality, Supply Chain, Commercial, Medical, Clinical, and non-Clinical development
• Manage external resources including Consultants and Contractors, as needed to deliver projects
• Travel to global manufacturing sites to support operations and validation activities

Benefits

Remote friendly role