Associate Director / Director, Chemical Development
San Diego, CA
$180,000 - $210,000
Job Description
We are 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.
Our company was ranked #2 mid-size company on The San Diego Union-Tribune's 2022 Top Workplaces list.
Job Summary:
The Associate Director / Director of 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 commercialization with specific focus on delivering drug substance to support clinical and commercial needs for all small molecule programs.
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 material 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 Chemical Development on CMC subteams.
· Responsible for phase appropriate synthetic route design and implementation of control strategies for regulatory starting materials and drug substance.
· 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 Chemical Development timelines/objectives.
· Contribute to quarterly updates of Chemical 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 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 to ensure that synthetic route, final solid form, and compound properties are suitable for development.
· Support PAR, DOE studies, and validation activities for drug substance.
Educational and Experience Requirements:
· Ph.D. with 9+ years of experience or BS/MS with 15+ 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.
· Ability to effectively manage and develop a high functioning team.
· Recruit, develop and retain top Chemical Development talent to drive the organizational strategy, next generation manufacturing teams, and lifecycle management.
Pay & Benefits:
The annual base salary for this position ranges from $180,000 to $210,000 depending on relevant skills, 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. Relocation assistance may be available based on business needs and/or eligibility.