Director, Global Drug Substance Commercialization, Conjugation

About the role

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Director, Global Drug Substance Commercialization, Conjugation based in United States. The Director will lead global drug substance commercialization activities for glycoconjugate manufacturing processes. This role focuses on launch readiness, commercial supply, technical planning, and execution across polysaccharide activation and conjugation. You will provide scientific and strategic leadership across internal teams, external manufacturing partners, and regulatory stakeholders. The position plays a critical role in ensuring robust processes, successful technology transfers, validation, and commercial lifecycle management. You will collaborate across Regulatory, CMC, Quality, Supply Chain, Procurement, Process Engineering, and Manufacturing functions. The role combines deep technical expertise with organizational leadership, strategic planning, and cross-functional influence. This is a remote U.S. opportunity, with a preference for candidates located in Raleigh, North Carolina, and requires 10–30% travel.

Responsibilities

• Provide strategic and scientific leadership for polysaccharide activation and conjugation processes across commercialization activities.
• Lead technical launch planning and execution for glycoconjugate drug substances and associated raw materials.
• Drive successful execution of launch plans and post-launch commercial activities.
• Establish and maintain robust commercialization strategies for conjugation manufacturing processes.
• Build and develop a highly skilled team supporting a global manufacturing network, with particular focus on conjugation processes.
• Provide recommendations on staffing and resource requirements needed to meet organizational and commercialization objectives.
• Continuously improve process understanding, robustness, and performance using laboratory and technical resources across the organization.
• Monitor, trend, and optimize manufacturing operations to strengthen process performance throughout the product lifecycle.
• Collaborate with Regulatory, CMC, Quality, Supply Chain, Procurement, Process Engineering, and other cross-functional teams.
• Support development and commercialization activities for carrier proteins and related pipeline products.
• Ensure robust processes and technical strategies are established for technology transfers and integration of new technologies.
• Provide technical support to internal and external manufacturing networks, including materials management and data analytics activities.
• Lead process validation and process comparability activities for commercialization programs.
• Communicate the scientific and commercial rationale behind polysaccharide and conjugation processes to manufacturing stakeholders.
• Participate in technical review and authoring of regulatory submissions related to commercialization.
• Support responses to technical questions from health authorities and regulatory agencies.
• Clearly communicate process performance, risks, opportunities, and recommendations to internal and external stakeholders.
• Establish strong working relationships across the global manufacturing organization and external partners.
• Contribute as the Drug Substance Commercialization lead for Conjugation and as a member of the broader Global Manufacturing Operations organization.
• Identify emerging technical or operational challenges and direct appropriate activities to develop effective solutions.
• Support appropriate planning and execution of commercial lifecycle management activities.
• Travel approximately 10–30% as required.

Requirements

• Bachelor’s, master’s, or doctoral degree in Chemical Engineering, Biochemical Engineering, Chemistry, Biochemistry, or a related discipline.
• Minimum relevant experience of 10+ years with a Ph.D., 12+ years with an M.S./M.A., or 16+ years with a B.S./B.A.
• Extensive experience with conjugate production processes, including polysaccharide activation, conjugation to carrier proteins, and associated purification processes.
• Experience working with conjugation processes across multiple operational scales.