Director, CMC Drug Substance: Small Molecules and Biologics

Glaukos Corporation • San Clemente, CA

3d

About The Position

The Director, CMC Drug Substance leads strategy and operational implementation for R&D, preclinical, and clinical product development and manufacturing through contract development and manufacturing organizations (CDMOs). The role oversees lifecycle management to support robust, compliant, and efficient production of active pharmaceuticals—including small molecules, biologics, and oligonucleotides—across the company’s product portfolio. It provides technical and operational leadership for API development and commercialization, with a focus on reliable supply, regulatory compliance, quality, cost optimization, and business alignment.

Serving as the primary liaison among Research & Development, Manufacturing, Quality, Regulatory Affairs, Supply Chain, and external manufacturing partners, this role advances active pharmaceutical development from early development through commercial production. The Director is the subject matter expert for API manufacturing technologies, raw materials, and process optimization, and supports CDMO selection, audits, technology transfer, manufacturing campaigns, process monitoring, continuous improvement, regulatory submissions, and inspection readiness.

Requirements

• 12 or more years of GMP manufacturing experience with a bachelor’s degree, or 8 or more years of GMP manufacturing experience with an advanced degree.
• A bachelor’s degree or an advanced degree in a relevant field, according to the applicable experience pathway.
• At least 3 years of leadership experience managing technical, manufacturing, and/or supply chain functions.
• Experience with small molecules is required.
• Expertise in active pharmaceutical synthesis and process chemistry for small molecules, including scale-up and manufacturing operations.
• Strong problem-solving skills and excellent written, verbal, and communication skills.
• Ability to manage multiple projects and competing priorities in a fast-paced environment.
• Knowledge of upstream and downstream biologics process development, such as bioreactors, fermenters, purification, formulation and filling, packaging, and/or distribution, as well as data analysis and regulatory requirements.

Nice To Haves

• An advanced degree (Master’s or PhD) in chemistry, chemical engineering, biochemistry, pharmaceutical sciences, or a related field.
• CDMO experience.
• Microbial, mammalian, and/or oligonucleotide experience.
• Expertise in oligonucleotide synthesis and process chemistry, including scale-up and manufacturing operations.

Responsibilities

• Lead strategy and operational implementation for active pharmaceutical development and manufacturing across R&D, preclinical, clinical, and commercial stages.
• Coordinate with R&D, Manufacturing, Quality, Regulatory Affairs, Supply Chain, and external manufacturing partners.
• Lead technology transfers and scale-up from R&D or pilot scale to GMP manufacturing and commercial-ready production using phase-appropriate controls.
• Lead the biologics team in providing technical support during manufacturing campaigns and troubleshooting equipment, raw materials, suppliers, investigations, and manufacturing challenges.
• Facilitate investigations into process deviations and yield or manufacturing issues.
• Analyze manufacturing data and use statistical tools to monitor process control and drive continuous improvement.
• Evaluate emerging technologies and identify opportunities to improve API manufacturing efficiency and robustness.
• Ensure manufacturing development activities comply with applicable GMP regulations, industry standards, and OSHA requirements.
• Work with CDMOs and partners to support audits, inspections, regulatory submissions, and inspection readiness.
• Collaborate with Regulatory Affairs by providing technical support for filings and reviewing CMC documentation related to active pharmaceutical development and production, including responses to regulatory inquiries.
• Support CDMO selection and audits.
• Demonstrate strategic planning and lead cross-functional initiatives.

What This Job Offers

• Job Type: Full-time
• Career Level: Director