Director, Commercial Manufacturing – Process Engineering

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Oversee daily management of commercial manufacturing operations, process engineering tasks, and continuous improvement projects.

• Lead initiatives for process optimization, troubleshooting, scale-up, PPQ, validation, and lifecycle management of commercial products.

• Assist in formulating the regulatory CMC strategy, including the development and assessment of Module 3 CTD submissions and responses to health authorities.

• Manage relationships with CDMO/CMO, ensuring high standards in technical, operational, quality, and regulatory performance throughout the supply chain.

• Collaborate across functions to facilitate successful product launches, technology transfers, supply chain expansion, and enhancements after approval.

• Spearhead operational improvement initiatives using Lean/Six Sigma methodologies to boost efficiency, lower costs, and improve manufacturing performance.

• Oversee project timelines, deliverables, and budgets, ensuring they align with the overall business and technical operational strategies.

⛳️ Requirements

• Bachelor’s or Master’s degree in Chemical Engineering, Pharmaceutics, Chemistry, or a related life sciences field.

• Over 10 years of experience in the pharmaceutical or biopharmaceutical CMC development, commercialization, and manufacturing sectors.

• Extensive experience managing drug substance and/or drug product manufacturing programs in regulated settings.

• Proven success in collaborating with CDMO/CMO partners and leading cross-functional technical operations projects.

• In-depth understanding of cGMPs, process validation, regulatory CMC requirements, and global drug development methodologies.

• Preferred experience in authoring and supporting Module 3 CTD submissions through to approval and commercialization.

• Strong capabilities in leadership, communication, problem-solving, and stakeholder management.

• Willingness to travel up to 30% domestically and internationally.

🏝️ Benefits

• Competitive salary and annual bonus.

• Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more.

• Generous parental leave and family planning benefits.

• Outstanding culture and opportunities for personal and professional growth.