Senior Scientist, Chemical Development

Essential Duties & Responsibilities

• Drive CDMO activities for late-stage drug substance development and manufacturing, including tech transfer, scale-up, process development, and optimization.
• Provide technical guidance and oversight (both internally and externally) to drive the phase-appropriate drug substance development.
• Serve as subject matter expert in chemical development and help drive best practices and technical advancements.
• Review and approve cGMP documents, including batch records, change controls, deviations, specifications, validation master plan, validation protocols/reports.
• Draft the CMC sections of regulatory filings, including IND/IMPDs and NDA/MAAs.
• Document development activities as source reports for regulatory filings.
• Work effectively with the cross-functional CMC team to ensure timely delivery of drug substance throughout the full drug lifecycle.
• Implement best practices and drive continuous improvements in the drug substance development process through technology innovation and problem solving.
• Proactively identify risks and communicate effectively with functional teams across all levels of the organization.
• Work in the lab to solve process chemistry issues (20% - 40%)

Requirements

• Knowledge of cGMP, ICH, and regulatory requirements

The Ideal Candidate

• PhD. with minimum of 5 years of experience in small molecule drug substance development, including management of external vendors/CDMOs or MS with minimum of 8 years of experience is desirable
• Experience with late-stage drug substance technical transfer
• Experience with control strategy development and capable of utilizing QbD principles to develop commercially viable manufacturing processes
• Highly proficient oral and written communication abilities
• Strong presentation skills highly desired
• Excellent collaboration, problem-solving, and organizational skills
• Comfortable in a fast-paced small company environment
• Ability to travel domestically and internationally (including Asian countries) up to 25% of the time to support ongoing manufacturing activities
• Bilingual in Japanese/English and able to act as a technical translator for written and verbal communication and technical documents strongly preferred

Education

• PhD. Organic Chemistry, Chemical Engineering, or related field