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Associate Director of Chemical Development and Drug Substance Manufacturing - SimplyBiotech

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Associate Director of Chemical Development and Drug Substance Manufacturing- Simply Biotech     
Are you looking for a new career opportunity with an exciting biotech company?! Then we've got the right team for you! In this role, you're responsible for the duties listed below.     
Immediate opening for an Associate Director of Chemical Development and Drug Substance Manufacturing with a biopharmaceutical company in South San Francisco, CA who possesses:      
  • Ph.D. in Chemistry or closely related and 5+ years of industry experience with small molecule drug substance development
  • Must have 3+ years of experience within oral dosage small molecules
  • Must have experience authoring CMC sections for regulatory submissions
  • Experience with CMO management is a BIG plus 
Email resumes to kbrace@simplybiotech.com or call 858.683.8559    
The selected candidate will be responsible for:    
  • Develop chemical processes for manufacturing drug substances
  • Manage and mentor process chemists internally and at contract manufacturers (CMOs)
  • Manage development activities for cGMP drug substance manufacturing of small molecule drugs at CMOs
  • Contribute to the development of target drug substance profiles and specifications, setting goals and maintaining timelines for CMO manufacturing activities
  • Ensure quality, economics, and adequate supply chain security for drug substances
  • Contribute to identifying and facilitating purchase of custom raw materials and supplies needed for drug substance manufacturing under tight time constraints
  • Develop and maintain good relationships and contracts with CMOs
  • Visit, evaluate and audit contract sites for GMP manufacturing activities
  • Coordinate production schedules based on preclinical and clinical development requirements
  • Review proposals, negotiate prices, recommend suppliers, verify delivery, and maintain necessary records
  • Work cross functionally with CMC analytical team and formulations team, QA and Regulatory teams
  • Work collaboratively with partners for all drug substance related activities
  • Compile documentation and draft CMC sections for regulatory submissions
  • Support interdisciplinary working teams with recommendations, advice and action plans for drug substance related issues
  • Represent the drug substance team in cross-functional working teams, and communicate drug substance related issues and information to groups within the company
 The selected candidate will also possess:  
  • Ph.D. in Chemistry
  • Strong synthetic organic chemistry knowledge and problem solving skills
  • Strong understanding of solid state properties of small molecules
  • 8+ years of experience in small molecule drug substance development
  • Direct experience with management of CMOs
  • In depth understanding and knowledge of industry practices in drug substance manufacturing and supply
  • In depth knowledge of cGMP regulations and compliance
  • Good understanding and knowledge of analytical methods and related issues
  • Experience in writing CMC sections for Regulatory submissions
  • Strong understanding of drug development process from R&D through commercialization
  • Strong written and verbal communication skills
  • Strong organizational skills and ability to effectively manage multiple priorities and projects
  • Ability to travel domestically and internationally
 Salary Range: $180k-220k/yr  
For immediate and confidential consideration, please email your resume to kbrace@simplybiotech.com or call 858.683.8559. More information can be found at www.simplybiotech.com