Senior Manager, Global Drug Substance Commercialization, Conjugation
Vaxcyte, San Carlos, CA, United States
The Senior Manager for Drug Substance (DS) Commercialization has responsibility for launch readiness and commercial supply of the conjugate drug substance. The conjugate product strategy transitions from Process Development to Manufacturing Science and Technology (MSAT) during late‑stage development. 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. It also provides leadership to ensure the organization can effectively communicate the scientific and commercial rationale for the conjugation process to internal stakeholders, CMOs, and regulatory agencies. The incumbent will be highly skilled in written communication, especially authoring Health Authority submissions (IND/BLA), and will interact effectively with people from diverse backgrounds and perspectives. The incumbent will work with the organization to ensure on‑time execution and appropriate planning for commercial lifecycle management. This position reports to the Director for Global DS Commercialization, Conjugation, and the Sr. Manager collaborates on overall program strategy with primary responsibility and accountability for the drug substance strategy.
Essential Functions
Provide strategic and scientific leadership for polysaccharide‑to‑protein conjugation with internal and external stakeholders and ensure successful execution of launch plans and post‑launch commercial activities.
Build a strong, highly‑skilled team for the global network with a focus on manufacturing processes and support resourcing recommendations.
Continuously improve process understanding and robustness by implementing systems to monitor, trend, and optimize operations.
Collaborate with cross‑functional teams (Regulatory, CMC, Quality, Supply Chain, Procurement, Process Engineering) to drive the successful development and commercial launch of the conjugate drug substance, and represent technology transfer, product launch, lifecycle, and retirement.
Ensure robust processes exist to support technical transfers and integration of new technologies.
Support internal and external manufacturing networks, including materials management and data analytics.
Support execution of process validation and comparability activities.
Engage in technical reviewing and authoring of regulatory filings, responding to health authority questions, and effectively communicating scientific and commercial rationale for DS processes.
Effectively and efficiently communicate process performance to key stakeholders and build strong working relationships with others.
Set clear and challenging goals, take accountability for driving results, adapt nimbly, and lead others through complex situations.
Contribute with the DS Commercialization lead and as a member of Global Manufacturing Operations to ensure effective and efficient delivery of therapies to patients; delegate effectively, celebrate diversity, and manage team performance with a focus on colleague development.
Travel: 10–30% travel required.
Requirements
Degree(s) in Chemical or Biochemical Engineering, Chemistry, Biochemistry, or related discipline with minimum experience: 5+ years (Ph.D.), 8+ years (M.S./M.A.), or 12+ years (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 authoring Health Authority submissions (IND/BLA).
Proactively recognizes needs and potential challenges, and independently identifies and implements effective solutions.
The ability to seek and analyze data from a variety of sources to support decisions and align others with the organization’s overall strategy.
An entrepreneurial and creative approach to developing new, innovative ideas that stretch the organization and push industry boundaries.
Reports to: Director, Global MSAT Commercialization Lead, Conjugation
Location: San Carlos, CA or North Carolina
Compensation The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $165,000 – $193,000 (SF Bay Area). Salary ranges for non‑California locations may vary.
We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.
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Essential Functions
Provide strategic and scientific leadership for polysaccharide‑to‑protein conjugation with internal and external stakeholders and ensure successful execution of launch plans and post‑launch commercial activities.
Build a strong, highly‑skilled team for the global network with a focus on manufacturing processes and support resourcing recommendations.
Continuously improve process understanding and robustness by implementing systems to monitor, trend, and optimize operations.
Collaborate with cross‑functional teams (Regulatory, CMC, Quality, Supply Chain, Procurement, Process Engineering) to drive the successful development and commercial launch of the conjugate drug substance, and represent technology transfer, product launch, lifecycle, and retirement.
Ensure robust processes exist to support technical transfers and integration of new technologies.
Support internal and external manufacturing networks, including materials management and data analytics.
Support execution of process validation and comparability activities.
Engage in technical reviewing and authoring of regulatory filings, responding to health authority questions, and effectively communicating scientific and commercial rationale for DS processes.
Effectively and efficiently communicate process performance to key stakeholders and build strong working relationships with others.
Set clear and challenging goals, take accountability for driving results, adapt nimbly, and lead others through complex situations.
Contribute with the DS Commercialization lead and as a member of Global Manufacturing Operations to ensure effective and efficient delivery of therapies to patients; delegate effectively, celebrate diversity, and manage team performance with a focus on colleague development.
Travel: 10–30% travel required.
Requirements
Degree(s) in Chemical or Biochemical Engineering, Chemistry, Biochemistry, or related discipline with minimum experience: 5+ years (Ph.D.), 8+ years (M.S./M.A.), or 12+ years (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 authoring Health Authority submissions (IND/BLA).
Proactively recognizes needs and potential challenges, and independently identifies and implements effective solutions.
The ability to seek and analyze data from a variety of sources to support decisions and align others with the organization’s overall strategy.
An entrepreneurial and creative approach to developing new, innovative ideas that stretch the organization and push industry boundaries.
Reports to: Director, Global MSAT Commercialization Lead, Conjugation
Location: San Carlos, CA or North Carolina
Compensation The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $165,000 – $193,000 (SF Bay Area). Salary ranges for non‑California locations may vary.
We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.
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