Senior Director, Small Molecule Drug Substance Development

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide strategic, scientific, and operational direction for small molecule API development, from candidate selection to commercial readiness.

• Establish and implement development strategies and plans for drug substances and APIs.

• Lead the selection of routes, process chemistry, optimization, impurity control, scale-up, and manufacturing strategies.

• Ensure the implementation of safe, robust, scalable, and commercially viable manufacturing processes.

• Support clinical supply, regulatory submissions, process validation, and readiness for commercial launch.

• Identify technical and operational risks and develop appropriate mitigation strategies.

• Oversee the development of process characterization and process control strategies.

• Assess novel technologies and manufacturing methods.

• Provide oversight and guidance for CDMO technology transfer, scale-up, and manufacturing activities.

• Contribute to due diligence, business development evaluations, portfolio assessments, departmental planning, performance metrics, and resource strategies.

• Manage departmental budgets, external development costs, and consulting resources.

• Author, review, and approve drug substance sections for INDs, IMPDs, CTAs, NDAs, MAAs, and related global filings.

• Offer input into regulatory strategies and interactions with health authorities.

• Present and justify development strategies during inspections, audits, and agency meetings.

• Collaborate with drug product development, analytical sciences, quality assurance, regulatory affairs, supply chain, and other stakeholders.

• Lead, mentor, and develop process chemists, scientists, and drug substance development professionals.

• Enhance technical capabilities while promoting scientific rigor, innovation, accountability, collaboration, and continuous improvement.

⛳️ Requirements

• Preferred: PhD in Organic Chemistry, Process Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related scientific field.

• A Master's degree with significant relevant industry experience may be considered.

• Over 15 years of progressive experience in drug substance development within the pharmaceutical or biotechnology sector.

• Leadership experience in small molecule process chemistry and API development.

• At least 5 years of experience in leading scientific teams and managing personnel.

• Proven track record of advancing multiple small molecule programs from candidate nomination through late-stage clinical development and readiness for commercialization.

• Significant experience in process chemistry, technology transfer, scale-up, and API commercialization activities.

• Extensive experience in managing CDMOs and external development partners.

• Demonstrated capability to lead cross-functional initiatives within a matrixed organization.

• Experience in managing departmental budgets and resource allocation.

• In-depth knowledge of synthetic organic chemistry and pharmaceutical process development.

• Strong understanding of route selection, process optimization, scale-up, technology transfer, process characterization, validation, and commercial manufacturing.

• Comprehensive knowledge of global drug substance CMC requirements and relevant regulatory guidelines.

• Experience with impurity control strategies, genotoxic impurity management, and process control strategies.

• Strong grasp of pharmaceutical development principles from early development to commercialization.

• Familiarity with modern manufacturing technologies and external manufacturing business models.

• Strategic thinker with strong scientific judgment and business insight.

• Ability to build, motivate, and lead high-performing technical teams.

• Excellent project management and prioritization skills.

• Ability to influence stakeholders and facilitate decision-making across complex organizations.

• Exceptional verbal, written, and presentation skills.

• Strong interpersonal abilities and capacity to cultivate productive internal and external relationships.

• Capability to operate effectively in a fast-paced and dynamic development environment.

🏝️ Benefits

• Comprehensive medical, dental, vision, and prescription drug coverage.

• Company-sponsored basic life insurance.

• Accidental death and dismemberment insurance.

• Short-term and long-term disability insurance.

• Tuition reimbursement.

• Student loan assistance.

• Generous 401(k) matching.

• Flexible time off.

• Paid holidays.

• Paid leave programs.

• Additional company-provided benefits.

• Incentive opportunities.