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Director, Process Validation and Risk Management
San Carlos, California, United States
Join our Mission to Protect Humankind!
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, periodontitis and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.
WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values:
*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.
*AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.
*LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.
*MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.
Summary:
The Director, Process Validation and Risk Management has the accountability for:
- Commercial process validation of the Vaxcyte end -to-end processes
- Identification, assessment, and mitigation of operational, technical, and regulatory risks within the end-to-end manufacturing processes
In this role the Director will be a part of the Global MSAT organization reporting to the Sr. Director of Process Validation. This role will be immersed in all aspects of operations in a commercial setting, which includes:
- Development of Process Validation/Process Performance Qualification/CPV strategy for the life cycle of products, ensuring alignment with regulatory guidelines and industry standards.
- Apply a fundamental understanding of bioprocessing to support continuous process validation for commercial processes, new site/plant start-up, execution of validation projects and/or protocols and the collection of data to support completion of process validation activities.
- Provide guidance for the generation, resolution and closure of deviations and ensure safety and compliance of validation activities including support for regulatory filing, inspection, and other CMC and technology team activities.
- Influence engineering, facility, systems and method validations within the commercial organization.
- Lead the development and execution of risk assessments to identify potential risks and plan mitigation strategies to sustain processes in a state of inspection and regulatory compliance readiness
- Collaborate with business units and other stakeholders to ensure that operational risks are effectively managed and mitigated.
- Monitor and report on key risk indicators and risk events, providing regular updates to senior management.
- Ensure compliance with regulatory requirements and industry best practices related to operational risk management.
Manufacturing Science and Technology (MSAT) is responsible for successfully and seamlessly transitioning the vaccine process from Process Development to Commercial, developing and executing technical launch and commercialization strategy, continuously improving process robustness through to end of lifecycle, commercial process validation, and ensuring best possible patient outcomes while creating value for the enterprise. As part of the Commercial Manufacturing and Supply Chain organization, MSAT will lead the technical and process support for end-to-end commercial manufacturing, including Raw Materials, Polysaccharides, Carrier Proteins, Conjugation across all DS production and formulation, fill finish and packaging across all DP production.
Essential Functions:
- Raw Material Qualification – Provide guidance and establish principles for complex and critical raw material qualification with internal and external stakeholders to ensure consistent and reliable supply to the commercial processes.
- DS Validation – Provide strategic and scientific leadership for process verification and validation with internal and external stakeholders and ensure successful execution of launch plans and post launch commercial activities.
- Risk management - Develop and implement a risk management framework, collaborating with Quality on developing policies, procedures and tools for identifying, assessing, monitoring, and reporting risks.
- Interface - Collaboration with cross-functional teams across the network, including Regulatory, CMC, Quality, Supply Chain, Procurement, and Process Engineering, to drive the successful commercialization of pipeline products.
- Support technical services - Support of our internal and external manufacturing network validations, including qualification of raw materials.
- Process validation and comparability - Provide support for the execution of process validation and process comparability activities.
- Regulatory - 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 validation to the Boards of Health for regulatory submissions for commercialization.
- Communicate - Effectively and efficiently communicate process validation performance to key stakeholders (internal-facing and external-facing). Connect and build strong working relationships with others, demonstrating strong emotional intelligence and an ability to communicate clearly and persuasively.
- Executing for Results - Set clear and challenging goals and take accountability for driving results. Comfortable with ambiguity and uncertainty; the ability to adapt nimbly and move forward through complex situations.
- Leadership – Provide technical leadership and contribute as a member of the Global MSAT organization, with an aim to ensure effective and efficient delivery of our life enhancing therapies to our patients.
- Travel - 10-30% domestic and international travel required.
Requirements:
- Degree(s) in Chemical or Biochemical Engineering, Chemistry, Biochemistry, Biotechnology or related discipline with a minimum of 10+ years of relevant experience for Ph.D., 12+ years for M.S./M.A. or 16+ years for B.S./B.A. Protein synthesis process experience preferred with a background of process and support system validation, MSAT/Technical Operations/Late phase process development/Commercialization.
- Broad experience in understanding aspects of process characterization, product development, multivalent vaccines, and relevant fill finish unit operations across multiple operational scales.
- Technical leadership experience in Process or Product validation strategy supporting technology transfer, project management and regulatory documentation.
- Experience in quality risk management and ICH Q9; strong knowledge of quality risk management frameworks, methodologies, and regulatory requirements.
- Ability to develop a full and deep understanding of the operational, technical and quality operations, both internally and externally, and how they create value and risk for the overall organization
- 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 collaborates 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.
- An entrepreneurial and creative approach to developing new, innovative ideas that will stretch the organization and push the boundaries within the industry.
Reports to: Sr. Director, Process Validation
Location: San Carlos, CA
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $208,000 – $243,000 (SF Bay Area). Salary ranges for non-California locations may vary.
Relocation:
This role is not eligible for any relocation assistance.
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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