Process Chemist Director

About This Opportunity

We are representing a confidential pharmaceutical organization seeking a Process Chemist Director to provide senior technical leadership across development-stage small molecule programs. This is a primarily remote role based in the United States with periodic travel for CDMO visits and internal meetings.

This position reports to the VP of CMC Development and plays a critical role in developing robust, scalable, and phase-appropriate drug substance manufacturing approaches from early development through commercialization. You'll work in a highly cross-functional, matrixed environment requiring strong scientific judgment, operational leadership, and the ability to influence decisions through expertise and collaboration.

Responsibilities

• Lead drug substance development strategies for small molecule programs, providing process chemistry expertise to support aligned CMC and program objectives
• Provide scientific and technical leadership on route selection, process development, optimization, control strategy, and scale-up activities
• Oversee external process development and manufacturing activities at CDMOs, providing technical input, risk identification, and guidance on timelines and budgets
• Contribute to phase-appropriate control strategies for starting materials, intermediates, APIs, impurities, and critical process parameters
• Provide technical input to technology transfer activities and support engineering, registration, validation, and commercial readiness
• Serve as drug substance subject matter expert for regulatory submissions and agency interactions, including INDs, CTDs, NDAs, MAAs, and health authority responses
• Partner with cross-functional teams including Formulation Development, Analytical Development, Supply Chain, QA, Regulatory Affairs, and clinical teams
• Facilitate scientific problem solving related to process performance, manufacturability, impurity trends, and lifecycle improvements
• Build and maintain relationships with external partners, consultants, and contract laboratories
• Mentor and develop scientists and matrix team members while fostering a culture of scientific excellence and collaboration
• Ensure accurate, timely, and inspection-ready documentation of development work and technical reports

What We're Looking For

Required Qualifications:

• PhD in Organic Chemistry, Process Chemistry, Pharmaceutical Chemistry, or related scientific discipline (exceptional candidates with Master's or Bachelor's degree and significant relevant experience may be considered)
• Minimum 10 years of pharmaceutical or biotechnology industry experience in process chemistry or drug substance development
• Demonstrated expertise in synthetic route design, process optimization, scale-up, impurity control, and technology transfer for small molecule APIs
• Strong working knowledge of cGMP manufacturing, CMC development, regulatory expectations, and global quality standards
• Experience authoring or reviewing regulatory submission content and supporting health authority interactions
• Proven success providing technical oversight to CDMOs and contract laboratories
• Experience supporting programs from early development through late-stage development and/or commercialization
• Ability to travel periodically for CDMO visits and internal meetings

Preferred Qualifications:

• Prior people management experience (strong matrix leadership experience will also be considered)
• Japanese language proficiency to enhance collaboration with international colleagues

Key Skills and Abilities:

• Strong leadership presence with ability to influence direction and contribute to key technical decisions
• Deep scientific curiosity and practical, risk-based approach to development challenges
• Excellent communication skills with ability to present complex technical information to senior leadership
• High degree of organizational awareness and ability to connect interdependencies across functions
• Strong collaboration and influencing skills in matrixed, global environments
• Ability to manage multiple priorities and adapt to changing business needs

How We Work With You

When you apply through Get A Job.ai, our recruiting team will review your qualifications and conduct an initial screening. If there's a strong match, we'll submit your profile to our client for consideration. Please do not contact the client directly—all communication and coordination will flow through our talent team to ensure a smooth and professional process.

Pay

The base salary range for this role at the client organization is $207,000 to $258,700. Total compensation includes merit-based increases, short incentive plan participation, 401(k), comprehensive medical/dental/vision benefits, life and disability insurance, flexible paid time off, 11 paid holidays, year-end shutdown period, and 80 hours of paid sick time annually.

Equal Employment Opportunity: Get A Job.ai is committed to inclusive hiring practices. We welcome applications from qualified candidates of all backgrounds and will ensure fair consideration throughout the recruitment process.