Director, CMC Drug Substance: Small Molecules and Biologics

How You'll Contribute

Leading the strategy and operational implementation for R&D, pre-clinical and clinical product development and manufacturing (Contract Development and Manufacturing - CDMOs): life cycle management to ensure robust, compliant, and efficient production of active pharmaceuticals including small molecules, biologics and oligonucleotides across the company's product portfolio. This role provides technical and operational leadership for API development and commercialization, ensuring consistent supply, regulatory compliance, quality performance, cost optimization, and alignment with overall business objectives.

This individual serves as the primary liaison between Research & Development, Manufacturing, Quality, Regulatory Affairs, Supply Chain, and external manufacturing partners to advance active pharmaceuticals development across salient programs from development through commercial production. This individual will serve as the subject matter expert for API manufacturing technologies, raw materials, and process optimization.

What You'll Do

• Support the CDMO/Glaukos manufacturing, quality, R&D, supply chain, and regulatory teams.
• Technology Transfer: Lead the scale up processes from R&D or pilot scale to GMP manufacture and ultimately commercial-ready manufacturing, employing phase-appropriate controls.
• Manufacturing Support: Lead the biologics team to provide technical support during campaigns and troubleshooting equipment, raw materials, suppliers, or investigations; facilitate investigations into process deviations, yield improvements, and manufacturing challenges.
• Process Monitoring & Optimization: Analyze manufacturing data to ensure processes remain in a state of control, using statistical tools to drive continuous improvement; evaluate emerging technologies and identify opportunities to improve API manufacturing efficiency and robustness.
• Quality & Compliance and Regulatory Support: Ensure the manufacturing development activities comply with applicable GMP regulations, industry standards and OSHA requirements.
• Work closely with CDMOs and partners to support audits, inspections, regulatory submissions and maintain inspection readiness.
• Collaborate with Regulatory to provide technical support for filings and review CMC documentation related to active pharmaceuticals development and production including supporting responses to regulatory enquiries.
• Expertise in active pharmaceuticals synthesis and process chemistry for small molecules and oligonucleotides including scale-up and manufacturing operations; sound knowledge for upstream and downstream process development for biologics (e.g., bioreactors, fermenters, purification, formulation and filling, packaging, and/or distribution), data analysis, and regulatory knowledge.
• Support CDMO selection and audits. Demonstrated strategic planning and lead cross-functional initiatives.
• Strong problem-solving skills, excellent written, verbal and communication skills. Ability to manage multiple projects and competing priorities in a fast-paced environment

How You'll Get There

Required Qualifications

• 12+ years of experience in GMP manufacturing with a bachelor's degree or 8+ years of experience in GMP manufacturing with an advanced degree (Master's or PhD).
• Advanced degree (Master's or PhD) in chemistry, chemical engineering, biochemistry, pharmaceutical sciences or a related field preferred.
• 3+ years of leadership experience managing technical, manufacturing and/or supply chain.
• CDMO experience is preferred.
• Small molecules required.
• Microbial, mammalian, and/or oligonucleotide experience preferred.
• Expertise in active pharmaceuticals synthesis and process chemistry for small molecules and oligonucleotides including scale-up and manufacturing operations; sound knowledge for upstream and downstream process development for biologics (e.g., bioreactors, fermenters, purification, formulation and filling, packaging, and/or distribution), data analysis, and regulatory knowledge.
• Support CDMO selection and audits. Demonstrated strategic planning and lead cross-functional initiatives.
• Strong problem-solving skills, excellent written, verbal and communication skills. Ability to manage multiple projects and competing priorities in a fast-paced environment.

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