Job Summary:
The Principal Scientist, Chemical Development will successfully develop robust synthetic processes and deliver non-GMP & GMP material on multi-kilogram scale in a safe, environmentally conscious, and efficient manner. This individual will be responsible for implementing strategies to progress compounds from preclinical development through proof-of-concept with specific focus on delivering drug substance to support preclinical and clinical needs for all Vividion small molecule programs.
Requirements
Essential Duties and Responsibilities:
- Lead a team of external scientist(s) to conduct synthetic route scalability assessment, route scouting (as necessary), route selection, and route optimization to deliver non-GMP & GMP API (active pharmaceutical ingredient) on multi-kilogram scale.
- Proactively work with CDMO partners to manage process development and manufacturing of intermediates and API; management of API/retain inventory.
- Represent Drug Substance Development on research core teams and CMC subteams.
- Responsible for phase appropriate synthetic route design and implementation of control strategies for regulatory starting materials and API.
- Lead fate and purge studies and genotoxic impurity evaluation.
- Lead technical transfers of intermediate/API processes and support external manufacturing activities by acting as PIP (person in plant).
- Work cross-functionally to communicate Drug Substance Development timelines/objectives.
- Contribute to quarterly updates of Drug Substance Development budget & resource allocation.
- Author and review the relevant CMC sections for US and ex-US regulatory filings.
- Work with quality assurance (QA) to manage the external manufacture and release of GMP drug substance and resolve technical issues or deviations.
- Review and approve master batch records, validation protocols/reports, and specifications required for drug substance manufacturing, as well as author development reports.
- Monitor compounds in preclinical development and develop synthetic routes to key cores for advanced leads.
- Work with Medicinal Chemistry, Preformulation Sciences, Analytical Development, and Drug Product Development to ensure that synthetic route, final solid form, and compound properties are suitable for development.
- Support API manufacturing process tech transfer prior to proof-of-concept.
Education and Experience Requirements:
- Ph.D. with 6+ years of experience or BS/MS with 10+ years of experience in organic chemistry, chemical engineering, pharmaceutical sciences or closely related discipline with relevant small molecule development experience.
- Knowledge and implementation of ICH Guidelines and current Good Manufacturing Practices (cGMPs).
- Knowledge of API solid state properties and the potential impact to drug product manufacturing and performance.
- Ability to manage multiple projects spanning all phases of development and rapidly adapt to changing program needs.
- Strong track record in process chemistry development, CDMO management and multi-kilogram scale manufacturing.
- Excellent written and verbal communication skills.
- Ability to effectively organize and prioritize tasks to achieve deadlines.
Pay & Benefits:
The anticipated base salary for this position ranges from $165,000 to $185,000 depending on relevant skills, competencies, experience, and education. In addition, this position is eligible for target bonus, long-term-incentives, 401k retirement savings plan with company match, and a comprehensive benefits package which includes medical, dental, vision, life, and disability insurance.
