Principal Scientist, Chemical Development

Vividion Therapeutics; San Diego (CA); Presencial; USD 165.000 - 185.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, dental, vision coverage

401k with company match

Bonus opportunities

Long-term incentives

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Process chemistry development

CDMO management

Multi-kilogram scale manufacturing

Project management

Communication skills

Leadership

Educación

PhD in chemistry/related field

BS/MS in chemistry/related field

Descripción del empleo

Description

Company Overview

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.

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.

EEO & Employment Eligibility

Vividion Therapeutics, Inc. is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other characteristic protected by applicable federal, state, or local laws.

Privacy Policy

The protection of your personal information is a commitment we take seriously. For information regarding our Privacy Policy (CA candidates) please visit https://vividion.com/privacy-notice/.