Sr Mgr, Drug Substance Process Development

Role Summary

Opportunity awaits those up to the challenge of developing transformative therapies across a broad range of debilitating diseases. The Sr. Manager, Drug Substance (DS) Process Development CMC will lead tech transfer, process qualification, and validation at contract drug substance manufacturing sites, with responsibilities spanning process scalability, PPQ, monitoring, optimization, and manufacturability of drug substance and key intermediates. The role requires broad expertise in manufacturing and late-stage/commercial operations, supporting cross-functional teams, and providing technical support for early-stage, late-stage, and lifecycle projects.

• Serve as technical expert on internal/external projects (process implementation, validation, tech transfer).
• Oversee product launch, tech transfer, process characterization (e.g., DOE, fate/purge studies), validation, and change management.
• Support risk management and troubleshooting for major deviations/change controls in collaboration with the supplier relationship team (SRT).
• Manage development and manufacturing activities through transparent communication and strategic alignment.
• Lead technical transfer and lifecycle planning from a manufacturing/scientific perspective.
• Proactively resolve technical challenges, deviations, and issues within scope.
• Ensure qualification/validation of processes, facilities, equipment, raw materials, and cleaning methods per GMP and global health regulations.
• Collaborate with cross-functional teams (PM, QC, QA, Supply Chain, Regulatory) for tech transfer, scale-up, and PPQ.
• Build strong relationships with development and manufacturing partners; coordinate with internal teams.
• Confirm equipment qualification as part of process validation (installation, operation, performance).
• Identify opportunities for continuous process improvement via trend analysis, technology advances, and industry standards.
• Support evaluation of major deviations, root cause analysis, CAPA, and change control with focus on quality, risk mitigation, and compliance.
• Apply risk management tools (e.g., FMEA, gap analysis) throughout lifecycle management.
• Develop data management processes for operational analysis, including Annual Product Review (APR) and Continous Process Verification (CPV).
• Contribute to writing and reviewing CTD Module 3 sections for regulatory submissions (IND, NDA, PAS, etc.).

• Bachelor’s degree in life sciences/engineering; advanced degree (MS/PhD) preferred.
• Extensive experience in cGMP development and manufacturing APIs.
• Deep knowledge of pharmaceutical processes, technologies, and systems; experience in process development, tech transfer, scale-up, validation, and manufacturing.
• Proven track record in process development or related fields.
• Experience in process validation and lifecycle management.
• Familiarity with CTD Module 3 authorship and regulatory standards (FDA, EMA, ICH).
• Strong attention to details and hands‑on approach to project management (data, reports, dashboards, budgets).
• Excellent technical, communication, problem‑solving, and organizational skills.
• Effective team player with ability to build strong internal/external relationships.
• Expertise in at least two modalities (e.g., peptides, oligonucleotides, biologics, small molecules, gene therapy) is a plus.

• Bachelor's Degree

• Travel: 10% travel