Director, CMC Drug Substance: Small Molecules and Biologics
About The Position
The Director, CMC Drug Substance provides strategic and operational leadership for research, preclinical, and clinical product development and manufacturing through contract development and manufacturing organizations (CDMOs). The role oversees lifecycle management to ensure robust, compliant, and efficient production of active pharmaceutical ingredients across small molecules, biologics, and oligonucleotides, supporting the company’s product portfolio. It is accountable for API development and commercialization, consistent supply, regulatory compliance, quality performance, cost optimization, and alignment with business objectives. The position serves as the primary liaison among Research & Development, Manufacturing, Quality, Regulatory Affairs, Supply Chain, and external manufacturing partners. It advances active pharmaceutical development from early development through commercial production and acts as a subject matter expert in API manufacturing technologies, raw materials, and process optimization.
Requirements
- At least 12 years of GMP manufacturing experience with a bachelor’s degree, or at least 8 years of GMP manufacturing experience with an advanced degree.
- 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.
- Knowledge of oligonucleotide synthesis and process chemistry, including scale-up and manufacturing operations.
- Sound knowledge of upstream and downstream biologics process development, such as bioreactors, fermenters, purification, formulation, filling, packaging, and/or distribution.
- Knowledge of data analysis and regulatory requirements.
- Strong problem-solving skills and excellent written, verbal, and communication skills.
- Ability to manage multiple projects and competing priorities in a fast-paced environment.
Nice To Haves
- A Master’s or PhD in chemistry, chemical engineering, biochemistry, pharmaceutical sciences, or a related field.
- CDMO experience.
- Microbial, mammalian, and/or oligonucleotide experience.
Responsibilities
- Support CDMO and Glaukos manufacturing, quality, R&D, supply chain, and regulatory teams.
- Lead technology transfer and scale-up from R&D or pilot scale through GMP manufacturing to commercial-ready manufacturing, 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 identify yield improvements and solutions to manufacturing challenges.
- Analyze manufacturing data to ensure processes remain in a state of control and use statistical tools to 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 and inspections, regulatory submissions, and inspection readiness.
- Collaborate with Regulatory Affairs on technical support for filings, review CMC documentation, and support responses to regulatory inquiries.
- Support CDMO selection and audits, and lead cross-functional initiatives and strategic planning.
- Manage multiple projects and competing priorities in a fast-paced environment.
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What This Job Offers
Job Type
Full-time
Career Level
Director
