Associate Director, Drug Substance

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

📋 Description

• Lead the development of late-stage drug substances, scale-up processes, and commercial manufacturing.

• Collaborate with internal CMC, Regulatory, and Quality teams to create, enhance, and establish robust, scalable processes for drug substance development.

• Direct the optimization and scale-up of manufacturing processes in partnership with external collaborators.

• Utilize Quality by Design (QbD) and Design of Experiments (DoE) methodologies to define Critical Process Parameters and Critical Quality Attributes.

• Manage the technical transfer of drug substance processes across global Contract Development and Manufacturing Organizations (CDMOs).

• Oversee scale-up initiatives and process validation campaigns in accordance with FDA, EMA, and other regulatory authorities.

• Supervise commercial-scale manufacturing operations, ensuring process consistency, yield enhancement, and supply chain robustness.

• Guarantee adherence to global cGMP and regulatory standards.

• Develop drug substance control strategies, which include impurity profiling and Proven Acceptable Ranges in compliance with ICH guidelines.

• Assist in the writing and review of CMC sections for global regulatory submissions and responses to inquiries from regulatory agencies.

• Work collaboratively with both internal and external stakeholders and report to the Sr. Director of Drug Substance Development.

⛳️ Requirements

• A Ph.D. or M.S. in Organic Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field.

• Over 8 years of advancing experience in drug substance development and manufacturing within the pharmaceutical sector, with an emphasis on late-stage development and commercialization.

• Robust experience in managing relationships with CDMOs and implementing outsourcing strategies.

• Proven track record in process development, scale-up, and technical transfers.

• Familiarity with global regulatory standards and cGMP compliance.

• Exceptional project management, organizational, and leadership capabilities.

• Capacity to thrive in a dynamic, cross-functional environment while influencing both internal and external stakeholders.

• Comprehensive understanding of material sciences and solid-state characterization techniques, including ssNMR, XRPD, and advanced spectroscopy.

• Strong verbal and written communication skills.

• Demonstrated hands-on experience in driving drug substance chemistry, manufacturing, and control (CMC) activities that support successful NDA submissions.

• Previous experience in preparing for, hosting, or managing a successful regulatory Pre-Approval Inspection (PAI).

• Acknowledged Subject Matter Expert in late-stage process characterization, including QbD, establishment of PAR/NOR, studies on the fate and purge of impurities, and ICH M7/nitrosamine safety evaluations.

• Highly knowledgeable and proficient in global ICH guidelines related to drug substance development and manufacturing.

• Experience with inhalation products is advantageous.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and continuous learning.

• Collaborative and innovative work environment.

• Flexible work arrangements to promote work-life balance.