Associate Director, Drug Substance, Pharmaceutical Development

2 weeks ago

Rockville, Maryland, United States Otsuka Pharmaceutical Co., Ltd. Full time
Job Summary

The Associate Director, Drug Substance, Pharmaceutical Development will lead process development and optimization of drug substances and will manage manufacturing activities for API, intermediate, and RSMs for assigned projects. The Associate Director, Drug Substance, Pharmaceutical Development will assist with the preparation and review of drug substance sections for regulatory submissions and will be responsible for the preparation and technical review of GMP documents for API, intermediate, and RSM manufacture.

Key Responsibilities
  • Responsible for chemical process development and optimization, technology transfer, scale-up, and process validation of APIs
  • Manage API, intermediate, and RSM manufacturing activities at CDMO sites to meet clinical supply demand
  • Direct the development activities of drug substances from early to late-stage projects in a phase-appropriate manner, which includes managing solid-state properties such as salt forms, solvates, and polymorphs, as well as process control strategies for impurities, potential mutagenic impurities (PMIs), elemental impurities, and residual solvents
  • Responsible to develop new and improved chemical manufacturing processes with an eye to reducing COGS, improving yields and upgrading quality of the drug substance, and provide technical support for existing chemical processes at CDMO sites
  • Draft, review, and approve GMP/scientific documents such as manufacturing batch records, protocols, and reports in compliance with cGMP and global regulatory requirements and the drug substance sections of global regulatory submissions such as INDs, IMPDs, NDAs, and MAAs.
  • Actively contribute expertise in cross-functional R&D project teams as the subject matter expert for drug substances and be well prepared to address any questions or discussions related to APIs for assigned projects
  • Coordinate inventory control of drug substances, starting materials, and key materials/reagents with internal and external partners to ensure project demands are met within timelines for assigned projects
  • Demonstrate excellent interpersonal skills and effective verbal and written communication skills with cross-functional teams (pharmaceutical development, clinical development, regulatory affairs, and quality assurance) and CDMO partners to build relationships and effectively progress projects forward
Requirements
  • PhD in Organic Chemistry, Chemical Engineering, or related sciences with 8+ years of relevant experience, or an MS in Organic Chemistry, Chemical Engineering, or related sciences with 10+ years of relevant experience
  • Experience in process development, API manufacturing, and regulatory compliance
  • Strong organizational skills to handle multiple priorities and meet project timelines
  • Excellent interpersonal, and written and verbal communication skills with a demonstrated ability to establish and maintain effective relationships internally and with external manufacturing partners
  • Ability to work strategically and independently with internal and external groups on multiple projects

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