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:*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.*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.*MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.
Summary:
Vaxcyte is looking for an accomplished, driven, energetic and pragmatic leader with extensive hands-on analytical development and validation experience, to join Vaxcyte’s Analytical Development & QC organization as a Senior Manager (SM) of Small Molecule Raw Material Method Validation and QC Lead. This pivotal role will lead method qualification/validation and oversee all QC activities in a complex network of approximately 4 Contract Development and Manufacturing Organizations (CDMOs). These small molecule raw materials encompass a diverse range non-natural amino acid and a linker that are used for intermediates, drug substances and drug products.
Expertise with analytical methods used for these small molecule raw materials is crucial. This position reports directly to the Sr Director of QC.
Essential Functions:
- Responsible for all deliverables of small molecule raw material method qualification/validation used in intermediates, DS and DP for various projects in the Vaxcyte pipeline.
- Contribute to and implement the high-level method qualification and validation strategy decided by CMC executive team. Accountable and responsible for implementing the detailed method qualification and validation strategy with the CMOs and CTLs.
- Collaborate with Analytical Development and interface with key stakeholders to determine when a small molecule raw material method is suitable for method validation and transfer. Review and evaluate method development data, reports, and documents to be transferred to CMOs, provide technical and compliance feedback to internal and external stakeholders who have developed the analytical methods.
- Collaborate with CDMOs to design an effective method validation plan, and lead method validation activities to ensure campaign readiness. May need to author method validation protocols and reports.
- Review and approve small molecule raw material test methods, method validation and/or method transfer protocols and reports, and responsible for the accuracy and compliance of these documents. The average number of documents to be reviewed per week is about 30.
- Accountable for execution of method implementation, validation, and transfer and responsible for supportive processes including sample planning, scheduling, documentation, compliance / technical review and scientific interpretation of data to ensure the successful validation / transfer of methods.
- Responsible for quality event management (deviations, investigations, change control) related to method qualification / validation.
- Manage outsourced GMP testing at CDMOs.
- Support audit, inspections, and health authority responses.
- Guide and work with others to identify opportunities for continuous improvement and implement solutions.
Requirements:
- PhD in Chemistry, Analytical Chemistry, or related field with 5+ years relevant industry experience; MS or BS with 10+ years of industry experience in Pharma / Biotech industry required.
- Demonstrate sound decision-making skills and exhibit good judgment. Make decision with an understanding of the strategic context and short- and long-term impact of decisions on other departments or functional areas.
- Successful track record of analytical method validation / transfer, and trouble shooting.
- Have solid understanding of principles of various analytical technology used for analysis of small molecule raw materials.
- Result oriented; good judgment in directing attention and effort across competing priorities, especially when resource constrained; implements “best practices” or leading-edge quality standards.
- Ability to manage project resource requirements (material, manpower, time, etc.), and to elevate relevant issues to analytical lead and line-management.
- Solid understanding of product development activities in biotech/drug/vaccine development, including key interdependencies, and knowledge of proven development strategies and tactics.
- Solid understanding of relevant FDA, EU, and ICH regulatory guidelines as applicable to analytical method validation for small molecule raw materials, and retest period.
- Demonstrate ability of applying regulatory guidance to formulate practical solutions and strategy for phase appropriate analytical method validation and transfer with a focus on small molecule raw materials.
- Ability to work globally with CMOs in different countries and continents.
- Self-starter and resourceful problem solver, and able to move up learning curve independently and map out intermediate milestones to achieve project goals.
- Experience in IND, NDA and BLA submission is highly preferred.
- Extensive technical writing experience in drafting analytical method validation and transfer protocols, reports, and method SOPs.
- Strong interpersonal skills and ability to communicate effectively both verbally and in written formats.
- Ability to work in a fast-paced, cross-functional environment and collaborate effectively with other team members.
Reports to: Senior Director, Quality Control, Raw Material and PolysaccharideLocation: San Carlos, CACompensation:The compensation package will be competitive and includes comprehensive benefits and an equity component.Salary Range: $180,000 – $187,000 (SF Bay Area). Salary ranges for non-California locations may vary.Vaxcyte, Inc. 825 Industrial Road, Suite 300San Carlos, CA 94070We 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.Apply for this job
Life at Vaxcyte
Thrive Here & What We ValueCourageously make the most complex biologics ever attempted to protect humankind | Model excellence with a shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.</s> | Models our Core Values: is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted.</s> | Rethink convention | Aim high | Lead with heart | Model excellence</s> | Vaxcyte is committed to protecting humankind from bacterial diseases through high-fidelity vaccines. | The company values creativity and intellectual diversity in all aspects of its work. | Vaxcyte aims to make the most complex biologics ever attempted to protect humankind. | The company leads with kindness-first, inclusive approach to collaboration and vigorous debate that advances business objectives. | Vaxcyte models excellence by demonstrating integrity, accountability, equality, and clarity across communications and decision-making.</s> | 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.</s> | AIM HIGH: Embody 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 business objectives. | RETHINK CONVENTION: Bring creative and intellectual diversity to every facet of work done in order to innovate and re-innovate the way vaccines are delivered. | MODEL EXCELLENCE: Demonstrate integrity, accountability, equality and clarity across communications and decision making.</s> | AIM HIGH: Courageously make the most complex biologics ever attempted to protect humankind. | LEAD WITH HEART: Kindness-first, inclusive approach to collaboration and vigorous debate that advances business objectives. | RETHINK CONVENTION: Creative and intellectual diversity to every facet of work done in order to innovate and re-innovate the way vaccines are delivered. | MODEL EXCELLENCE: Shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.</s> | Collaborative role working closely with the Supply Chain team to deliver a system that will support Vaxcyte's growth through commercialization. | Promote a culture of continuous improvement by identifying areas for enhancement and implementing best practices in SAP and APS program management.</s> | Shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making</s> | Kindness-first approach to collaboration and vigorous debate that advances business objectives | Vaxcyte's mission is to protect humankind from bacterial diseases, which have serious and costly health consequences when left unchecked. | The company values rethinking convention, aiming high, leading with heart, and modeling excellence in their work. | They prioritize collaboration across teams and strive for process improvement initiatives to enhance efficiency and compliance.</s> | 1. RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and reinnovate the way vaccines are delivered | 2. AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind | 3. LEAD WITH HEART: Everyone leads at Vaxcyte with a kindnessfirst, inclusive approach to collaboration and vigorous debate that advances our business objectives | 4. MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making</s> | Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases | Our work together is guided by four enduring core values: RETHINK CONVENTION, AIM HIGH, LEAD WITH HEART, and MODEL EXCELLENCE | 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.</s> | Bringing creative and intellectual diversity to every facet of the work done in order to innovate and re-innovate the way vaccines are delivered</s> | Join our mission to protect humankind from the consequences of bacterial diseases | Collaborate with various stakeholders to understand integration requirements and translate them into technical solutions | Stay up to date with the latest trends and technologies in integration, particularly within the Workato ecosystem | Participate in code reviews and ensure the quality of integration solutions | Proactively identify and address potential integration challenges | Manage and prioritize integration projects, ensuring timely delivery and within budget</s> | Shared commitment to demonstrating integrity, accountability, equality, and clarity across communications and decision making | 11. RETHINK CONVENTION: Creative and intellectual diversity in every aspect of work | 12. AIM HIGH: Courageously make the most complex biologics ever attempted to protect humankind | 13. LEAD WITH HEART: Kindnessfirst, inclusive approach to collaboration and vigorous debate that advances business objectives | 14. MODEL EXCELLENCE: Shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.</s> | The company leads with a kindness-first, inclusive approach to collaboration and vigorous debate that advances business objectives. | The company models excellence by demonstrating integrity, accountability, equality, and clarity across communications and decision-making.</s> | Collaborative and high-performance project team environment. | Aim high by embodying our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind. | Model excellence by demonstrating integrity, accountability, equality, and clarity across communications and decision making. | Lead with heart by everyone leading at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.</s> | 4. MODEL EXCELLENCE: Shared Commitment to Demonstrating Integrity, Accountability, Equality and Clarity Across Communications and Decision Making</s> | Courageous goal to make the most complex biologics ever attempted to protect humankind | Bringing creative and intellectual diversity to every facet of work to innovate and re-innovate the way vaccines are delivered</s> | Shared Commitment to Demonstrating Integrity, Accountability, Equality, and Clarity Across Communications and Decision Making</s> | Mission-driven: working towards protecting humankind from the consequences of bacterial diseases | Collaborative: guided by four enduring core values that prioritize collaboration and inclusion | Innovative: bringing creative and intellectual diversity to every facet of work to innovate and re-innovate the way vaccines are delivered | Ambitious: embodying a collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.</s> | Mission to protect humankind from bacterial diseases | Collaborative work environment guided by four core values: Rethink Convention, Aim High, Lead With Heart, Model Excellence | Commitment to scientific excellence, innovation, and integrity within the medical and clinical affairs team.</s> | Vaxcyte values creativity and intellectual diversity to innovate and re-innovate the way vaccines are delivered. | They aim high and embody their collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind. | They lead with heart, everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances their business objectives. | They model excellence by demonstrating integrity, accountability, equality, and clarity across communications and decision making.</s> | Rethink convention: bring creative and intellectual diversity to every facet of the work done in order to innovate and re-innovate the way vaccines are delivered | Caring: Vaxcyte is committed to protecting humankind from the consequences of bacterial diseases | Courage: Vaxcyte embodies a collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind | Excellence: Vaxcyte strives for world-class finance organization that is customer service-oriented and highly accountable | Passion: Vaxcyte's cultural attributes include caring, courage, excellence, and passion</s> | Kindness-first and inclusive approach to collaboration and vigorous debate that advances 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.</s> | Kindness-first, inclusive approach to collaboration and vigorous debate that advances business objectives</s> | 1. RETHINK CONVENTION: Creative and Intellectual Diversity to Innovate and ReInnovate the Way Vaccines are Delivered | 2. AIM HIGH: Embodiment of Collectively Audacious Goal to Courageously Make the Most Complex Biologics Ever Attempted to Protect Humankind | 4. MODEL EXCELLENCE: Shared Commitment to Demonstrating Integrity, Accountability, Equality, and Clarity Across Communications and Decision Making</s> | Collaborative culture | Continuous improvement mindset | Kindness-first, inclusive approach to collaboration and vigorous debate that advances business objectives.</s> | 1. RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and reinnovate the way vaccines are delivered. | 2. AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind. | 3. LEAD WITH HEART: Everyone leads at Vaxcyte with a kindnessfirst, inclusive approach to collaboration and vigorous debate that advances our business objectives. | 4. MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.</s> | Commitment to protecting humankind from bacterial diseases | Emphasis on continuous improvement and risk mitigation strategies | Rethink Convention: Bring creative and intellectual diversity to every facet of work to innovate and re-innovate the way vaccines are delivered. | Model Excellence: Shared commitment to demonstrating integrity, accountability, equality, and clarity across communications and decision making.</s> | Vaxcyte values creativity and intellectual diversity in every facet of the work they do | They model excellence by demonstrating integrity, accountability, equality and clarity across communications and decision making.</s>
