Associate Director / Director, Chemical Development

My name is Nick Davis and I am with InstantServe LLC. We're currently recruiting for a role that we think would be a great fit for someone with your skills and experience. Would you be open to learning more about this? I have included a brief job description below to help you better understand the qualifications we are looking for:

Our company places a high value on employee referrals, and we are willing to offer a generous referral bonus to anyone who successfully recommends a candidate that we end up hiring. If you know of anyone who you believe would be a great fit for this role, I would greatly appreciate it if you could provide a recommendation.

Job Title: Associate Director / Director, Chemical Development

Location: San Diego, CA

Job type: Full time Permanent

Shift: Full-time 8 hours a day 40 hours a week

Pay Range: USD $180 - $210k Yearly/Annually + target bonus, long-term-incentives, 401k + Benefits

Must-Haves

1minimum 9 years industry experience (NOT including postdoc)

2must be a process chemist with strong synthetic chemistry skills

3must be based in San Diego or willing to relocate to San Diego

Nice-To-Haves

1big pharma experience (Merck, Janssen, AbbVie, Gilead, Amgen)

Job Description

Company Overview:

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.

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.