Senior Manager, Global Drug Substance Commercialization, Conjugation

About the role

The Senior Manager for Drug Substance (DS) Commercialization plays a critical role in the launch readiness and commercial supply of the conjugate drug substance. This role involves technical launch planning and execution, coordination of cross-functional efforts for regulatory filings, facility readiness, and launch supplies. Additionally, this role provides leadership to ensure the organization is equipped to effectively communicate the scientific and commercial rationale for conjugation process to internal stakeholders, relevant CMOs, and regulatory agencies.

Responsibilities

• 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 and highly-skilled team for the global network with special focus on manufacturing processes.
• Continuously improve process understanding and process robustness by putting systems in place to monitor, trend, and optimize operations.
• Interface 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 the conjugate drug substance.
• Support the development and execution of technical launch and commercialization strategy, ensuring best possible patient outcomes while creating value for the enterprise.
• Engage in technical reviewing and authoring of regulatory filings and respond to questions received from health authorities.
• Effectively communicate the scientific and commercial rationale for DS processes to the Boards of Health for regulatory submissions for commercialization.
• Communicate process performance to key stakeholders (internal-facing and external-facing).
• Seek and analyze data from a variety of sources to support decisions and align others with the organization's overall strategy.
• Develop and implement new, innovative ideas that will stretch the organization and push the boundaries within the industry.

Requirements

• Minimum of 5+ years of relevant experience for a degree in Chemical or Biochemical Engineering, Chemistry, Biochemistry, or related discipline (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).
• Able to interact effectively with people of diverse backgrounds and perspectives.
• Proactive recognition of needs and potential challenges, and independent identification and implementation of effective steps and solutions.

Qualifications

• Proven track record of leading cross-functional teams and driving results.
• Strong interpersonal and communication skills, particularly in writing and presenting technical information to regulatory bodies.
• Ability to work independently and in a team environment.
• Experience with regulatory affairs and compliance.
• Knowledge of GMP guidelines and regulations.

Skills

• Technical expertise in polysaccharide/protein conjugate vaccines.
• Strategic thinking and planning.
• Collaborative leadership.
• Effective communication and presentation skills.
• Problem-solving and analytical skills.

Benefits

• Comprehensive benefits package.
• Equity component in compensation package.

Pay

• Salary Range: $165,000 – $193,000 (SF Bay Area).
• Salary ranges for non-California locations may vary.

Schedule

• Remote Location: San Carlos, CA or North Carolina.
• 10-30% travel required.

Company Information

• Vaxcyte is a clinical-stage vaccine innovation company.
• We are dedicated to eradicating or treating bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella.
• We are guided by four enduring core values: RETHINK CONVENTION, AIM HIGH, LEAD WITH HEART, and MODEL EXCELLENCE.