Director, Global Drug Substance Commercialization, Conjugation

This is a fully remote position, open to applicants in California, +1 more state.

📋 Description

• Oversee and facilitate the readiness for launch and commercial supply of glycoconjugate drug substances, which includes polysaccharide activation, conjugation, and related raw materials.

• Direct the technical planning and execution for regulatory submissions, facility preparedness, and launch supplies.

• Ensure clear communication of the scientific and commercial justifications for critical raw material manufacturing processes to internal stakeholders, Contract Manufacturing Organizations (CMOs), and regulatory bodies.

• Organize and carry out activities related to commercial lifecycle management.

• Offer strategic and scientific guidance for polysaccharide activation and conjugation procedures.

• Assemble and cultivate a highly proficient global conjugation manufacturing team, providing support for staffing decisions.

• Continuously enhance process knowledge and reliability by observing, analyzing trends, and optimizing operations.

• Collaborate with teams in Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC), Quality Assurance, Supply Chain, Procurement, and Process Engineering.

• Assist in technical transfers and the integration of new technologies.

• Support both internal and external manufacturing networks, materials management, and data analytics initiatives.

• Lead activities related to process validation and comparability.

• Review and draft regulatory submissions and address inquiries from health authorities.

• Convey process performance metrics to both internal and external stakeholders.

• Act as the Drug Substance Commercialization lead for Conjugation within Global Manufacturing Operations.

⛳️ Requirements

• Degree(s) in Chemical or Biochemical Engineering, Chemistry, Biochemistry, or a related field, with a minimum of 10+ years of relevant experience for Ph.D. holders, 12+ years for M.S./M.A. graduates, or 16+ years for B.S./B.A. graduates.

• In-depth experience in conjugate production processes, including polysaccharide activation, conjugation to carrier proteins, and associated purification methods across various operational scales.

• Experience with glycoconjugate vaccines is strongly preferred.

• Leadership experience in Manufacturing Science and Technology (MSAT) or Process Development in supervisory and/or matrixed team environments.

• Comprehensive technical knowledge applied collaboratively to formulate strategic plans and achieve shared objectives.

• Strong organizational, problem-solving, and strategic planning capabilities.

• Proficient in both verbal and written communication.

• Ability to engage effectively with individuals from diverse backgrounds and perspectives.

• Capacity to identify needs and challenges, implementing effective solutions accordingly.

• Ability to gather and analyze data from various sources to inform decisions and ensure alignment with organizational strategy.

• An entrepreneurial and innovative mindset in generating creative ideas.

• 10–30% travel may be required.

🏝️ Benefits

• Comprehensive benefits package.

• Equity component included.

• Flexible remote work arrangement.