Principal Scientist, Chemical Development

Vividion Therapeutics, Inc•San Diego, CA

1d•$165,000 - $185,000

About The Position

Vividion is a next generation biotechnology company based in San Diego that is leveraging its proprietary chemical proteomics platform to conduct proteome-wide footprinting of drug-protein interactions with unprecedented breadth and precision. Our technology allows us to screen, identify and optimize novel drugs that selectively bind virtually any protein, including proteins previously considered “undruggable”. Our pipeline and emerging programs reflect a matured and productive platform capable of delivering first in class drugs utilizing novel mechanisms of action (allosteric inhibitors, protein-protein interaction inhibitors, functional activators, degraders etc.) against undruggable targets in the oncology and immunology space. We prize scientific excellence, creativity, team players and we are committed to continued innovation. We have worked hard to create a collaborative and dynamic work culture where your ideas and discoveries are valued and will have an impact. We are growing and there are opportunities for mentorship and career progression. Vividion has been recognized as a Top Workplace by The San Diego Union-Tribune from 2022 to 2025. 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

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.

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.