Senior Manager, Global Drug Substance Commercialization, Conjugation

Role Overview

• The Senior Manager for Drug Substance (DS) Commercialization has the responsibility for launch readiness and commercial supply of the conjugate drug substance.
• This role focuses on technical launch planning and execution by bringing best-practices and coordinating cross-functional efforts for regulatory filings, facility readiness, and launch supplies.
• This role also provides leadership to ensure that the organization is equipped to effectively communicate the scientific and commercial rationale for conjugation processes to internal stakeholders, relevant CMOs, and to regulatory agencies.
• The incumbent will work with the organization to ensure on-time execution and appropriate planning for commercial lifecycle management.
• The role will also require the ability to interact effectively with people of diverse backgrounds and perspectives.

Requirements

• Degree(s) in Chemical or Biochemical Engineering, Chemistry, Biochemistry, or related discipline with a minimum of 5+ years of relevant experience for Ph.D., 8+ years for M.S./M.A., or 12+ years for B.S./B.A.
• Experience in development, tech transfer, scale-up or production of polysaccharide/protein conjugate vaccines
• Experience in MSAT or Process Development in supervisory and/or matrixed team roles.
• Able to leverage deep technical knowledge in a collaborative manner to achieve collective goals.
• Excellent organization, problem solving and strategic planning skills.
• Highly skilled in both verbal and written communication, especially in regards to authoring Health Authority submissions (IND/BLA) with the ability to interact effectively with people of diverse backgrounds and perspectives.
• Proactively recognizes needs and potential challenges, and independently identifies and implements effective steps and 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.
• An entrepreneurial and creative approach to developing new, innovative ideas that will stretch the organization and push the boundaries within the industry.

Benefits

• The compensation package will be competitive and includes comprehensive benefits and an equity component.