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  AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.

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  LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.

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  RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.

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  MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.

Essential Functions:

• Oversee commercial production, implementation and execution to ensure that production schedules are met, and products are manufactured according to current Good Manufacturing Practice guidelines.
• Directs and leads a team of manufacturing managers to accomplish the goals of the manufacturing department, consistent and with established manufacturing and safety procedures.
• Collaborates closely with Senior Management, Functional/Department Heads, and project team members.
• Coordinates resource planning across programs to ensure adequate resources are available, escalate and resolve issues.
• Supports CDMO in setting up and maintaining operational capabilities to maximize reliability of production.
• Builds confidence and then maintains relationships with the involved CDMOs
• Fosters an environment of performance, efficiency, compliance, continuous improvement, and exceptional quality standards at the CDMOs.
• Regularly ensures manufacturing operations are running efficiently and that all level of manufacturing personnel at CDMO are appropriately trained and qualified to perform work assigned.
• Implement and monitor key performance indicators, highlighting progress, risks, and mitigation options.
• Ensure that manufacturing equipment is properly maintained, calibrated, and qualified to guarantee consistent and reliable operation.
• Works closely with Quality Control and Supply Chain to ensure that raw materials, intermediate products, and finished pharmaceutical products meet quality standards and specifications.
• Closely tracks planned and scheduled manufacturing activities at CDMOs to optimize resource utilization and meet production targets while minimizing downtime and waste.
• Ensures together with Supply Chain the timely availability of raw materials, packaging components, and other resources required for manufacturing operations.
• Makes sure that accurate and up-to-date records of manufacturing processes, quality control testing, and regulatory compliance activities are available.
• Ensures compliance with regulatory requirements, including GMP, safety and environmental regulations, and other relevant guidelines.
• Supports validation and qualification activities for equipment, processes, and facilities to ensure compliance with regulatory requirements and industry standards.
• Reviews batch production records to ensure completeness, accuracy, and compliance with established procedures and specifications.
• Manages technical input to batch records and other quality documents according to ICH and FDA guidelines.
• Identify, recommend, develop and implement necessary changes, within the appropriate regulatory confines, to improve productivity and for continuous process improvements.

Requirements:

• Ph D in Biological science (Biotechnology, Biochemistry), or MS Degree/Bachelor in Biochemical Engineering.
• 12+ years of professional management experience in successful leading of GMP manufacturing and external manufacturing organizations.
• Demonstrated ability to work effectively at all levels of a manufacturing organization.
• Proven experience in a facility start-up and commercialization of manufacturing processes.
• Strong organizational management, teamwork, interpersonal skills, and professionalism.
• Demonstrated experience in setting up a high performing team, driving personal development and mentoring of team members
• Proven experience in managing Large Molecule GMP manufacturing facilities, microbial manufacturing experience desirable.
• Experience in establishing Quality and Safety mindset/ behaviors and a culture of continuous improvement.
• Relentless focus and passion around process improvements (efficiency and automation).
• Experience in creating, managing, and adhering to budgets.
• Manage multiple projects in a fast-paced environment.
• Ability to balance, prioritize, and solution-oriented manner.