Remote Associate Director, Global Drug Substance Commercialization, Conjugation

Summary

Join our team as the Associate Director for Drug Substance (DS) Commercialization of Conjugation and lead launch readiness and commercial supply of glycoconjugate drug substances. This role focuses on technical launch planning and execution, leadership, and communication with internal stakeholders and regulatory agencies.

Requirements

• Degree(s) in Chemical or Biochemical Engineering, Chemistry, Biochemistry, or related discipline
• Minimum 9+ years of relevant experience for Ph.D., 11+ years for M.S./M.A., or 14+ years for B.S./B.A
• Extensive experience in conjugate production processes, including polysaccharide activation, conjugation to carrier proteins, and associated purification processes across multiple operational scales
• Leadership experience in MSAT or Process Development in supervisory and/or matrixed team roles
• Able to leverage deep technical knowledge in a collaborative manner to establish strategic plans and achieve collective goals
• Excellent organization, problem solving and strategic planning skills
• Highly skilled in both verbal and written communication with the ability to interact effectively with people of diverse backgrounds and perspectives
• Proactively recognizes needs and potential challenges and directs activities to implement effective solutions
• The ability to seek and analyze data from a variety of sources to support decisions and to align others with the organization's overall strategy

Responsibilities

• Provide strategic and scientific leadership for polysaccharide activation and conjugation processes with internal and external stakeholders
• Ensure successful execution of launch plans and post-launch commercial activities
• Support building a strong and highly-skilled team for the global network with special focus on conjugation manufacturing processes
• Continuously improve process understanding and process robustness by working with staff and laboratory resources across the organization to monitor, trend, and optimize operations
• Collaborate with cross-functional teams across the network, including Regulatory, CMC, Quality, Supply Chain, Procurement, and Process Engineering, to drive the successful development and commercial launch of conjugate drug substances for pipeline products
• Ensure robust processes exist to support technical transfers and integration of new technologies
• Support of our internal and external manufacturing network, including materials management and data analytics
• Provide leadership for the execution of process validation and process comparability activities
• Engage In technical reviewing and authoring of regulatory filings and responding to questions received from health authorities
• Effectively communicate the scientific and commercial rationale for conjugation processes to the Manufacturing organization for commercialization
• Effectively and efficiently communicate process performance to key stakeholders (internal-facing and external-facing)
• Lead matrixed teams focused on Conjugation drug substance commercialization with an aim to ensure effective and efficient delivery of our life-enhancing therapies to our patients

Benefits

• Comprehensive benefits
• Equity component