Senior Scientist, Drug Substance Development (Multi-Kg)

Vividion Therapeutics, Inc; San Diego (CA); On-site; USD 165,000 - 185,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401k with company match

Bonus opportunities

Long-term incentives

Job summary

Vividion Therapeutics, Inc. in San Diego is seeking a Principal Scientist, Chemical Development to lead scalable synthesis and deliver non-GMP & GMP material for preclinical and clinical needs across all programs.

You will manage external partners, drive multi-kilogram scale manufacturing, oversee quality and regulatory readiness, and collaborate with Medicinal Chemistry, Analytical Development, and QA to ensure timely drug substance supply.

Qualifications

• PhD with 6+ years of relevant small molecule development experience OR BS/MS with 10+ years in organic chemistry/pharmaceutical sciences.
• Knowledge and implementation of ICH Guidelines and current Good Manufacturing Practices (cGMPs).
• Knowledge of API solid state properties and impact on drug product manufacturing and performance.
• Ability to manage multiple projects across development stages and adapt to changing program needs.
• Strong track record in process chemistry development and CDMO management.

Responsibilities

• Lead external scientists to scale synthetic routes and deliver non-GMP & GMP API on multi-kilogram scale.
• Collaborate with CDMO partners to manage process development and manufacturing of intermediates and API; manage inventory.
• Represent Drug Substance Development on research core teams and regulatory subteams.
• Design phase-appropriate synthetic routes and control strategies for starting materials and API.
• Lead impurity and genotoxic impurity evaluation and ensure compliance.
• Facilitate tech transfers of intermediate/API processes and support external manufacturing activities.
• Coordinate communication of timelines and objectives across teams.
• Contribute to Drug Substance Development budget and resource planning.
• Prepare and review CMC sections for regulatory filings.
• Coordinate QA involvement for external manufacture release and issue resolution.
• Review master batch records, validation protocols/reports, and specifications.

Skills

Process chemistry development

CDMO management

Multi-kilogram scale manufacturing

Project management

Communication skills

Leadership

Education

PhD in chemistry/related field

BS/MS in chemistry/related field

Job description

Vividion Therapeutics, Inc. in San Diego is seeking a Principal Scientist, Chemical Development to lead scalable synthesis and deliver non-GMP & GMP material for preclinical and clinical needs across all programs.

You will manage external partners, drive multi-kilogram scale manufacturing, oversee quality and regulatory readiness, and collaborate with Medicinal Chemistry, Analytical Development, and QA to ensure timely drug substance supply.