Job FunctionsMethod validation/transfer and cGMP-compliance in routine operationsQC lead for method validation/transfer of immunoassaysSupporting quality control activities including cGMP analytical testing at Contract Testing Organizations and Vaxcyte QC laboratory operations
Job RequirementsPhD in Biochemistry or immunology with 7+ of industry experience; MS or BS with 12+ years of industry experience in Pharma / Biotech industry requiredPrevious experience in validation and transfer of immunoassay and bioanalytical assay and method development experience is highly desiredAbility to work in a fast-paced, cross-functional environment and collaborate effectively with other team members
SkillsTechnical expertise in immunoassay and bioanalytical methodsStrong cGMP experienceAbility to integrate and interpret interdisciplinary project informationProficient with analytical software such as Softmax ProSolid understanding of relevant FDA, EU, and ICH regulatory guidelines and pharmacopeiaKindness-first approach to collaboration and vigorous debate that advances business objectivesStrong teamwork in establishing a quality culture and shared accountabilityAbility to work globally with CMOs in different countries and continentsProject management skills including the ability to manage project resource requirements (material, manpower, time, etc.)
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 energetic and talented individual to join our Quality Control team as an Associate Director. The position will be an integral part of the team responsible for method validation/transfer and cGMP-compliance in routine operations for immunoassays performed for all phases of clinical development for Vaxcyte’s PCV product. The primary responsibility will be the QC lead for method validation/transfer of immunoassays and include supporting of the quality control activities including cGMP analytical testing at Contract Testing Organizations and Vaxcyte QC laboratory operations.
The ideal candidate will apply technical expertise, strong cGMP experience, ensure compliant operations and documentation, foster open communication, and pursue data-driven approaches.
Essential Functions:
- Author/Review validation and transfer protocols, data and reports for immunoassay and bioanalytical assays. Collaborate with internal stake holders to set appropriate validation/transfer acceptance criteria.
- Collaborate with and interface with key internal stake holders to understand immunoassay and bioanalytical methods being performed onsite and at CMOs.
- Apply technical and compliance expertise to the review of immunoassay and bioanalytical test methods and in-process/release protocols, data and CoAs from CMOs.
- Provide technical and compliance feedback to internal and external stakeholders who have developed the immunoassay and bioanalytical methods.
- Manage outsourced cGMP and characterization testing supporting lot release.
- Manage sample submission forms, shipping and sample handling activities required between the CMOs to support on time validation immunoassay and bioanalytical assays.
- Serves as the QC liaison for outsourced immunoassay development, technology transfer and data management in a CRO or CMO/CDMO environment.
- Accountable for execution of quality control testing and supportive processes including sample /inventory management, scheduling, documentation, compliance review, results reporting (CoA), and scientific interpretation of data / method performance to ensure high quality data and control of immunoassay and bioanalytical methods.
- Responsible for quality event management (deviations, investigations, change control) related to immunoassay and bioanalytical assays.
- Author SOPs, technical reports and multiple regulatory submission when needed, and address health authority questions during various clinical phase filings.
- Work with others to identify opportunities for continuous improvement and implement/maintain solutions.
- Provide strong teamwork in establishing a quality culture and shared accountability.
Requirements:
- PhD in Biochemistry or immunology with 7+ of industry experience; MS or BS with 12+ years of industry experience in Pharma / Biotech industry required.
- A proven track record of solving complex immunoassay and bioanalytical problems.
- Previous experience in validation and transfer of immunoassay and bioanalytical assay and method development experience is highly desired.
- Ability to integrate and interpret interdisciplinary project information; with at least a high-level understanding of the drug/vaccine development process.
- Ability to work globally with CMOs in different countries and continents.
- Ability to work in a fast-paced, cross-functional environment and collaborate effectively with other team members.
- Fundamental understanding of statistics and data analysis software, proficient with analytical software such as Softmax Pro.
- Strong interpersonal skills; ability to communicate effectively both verbally and in written formats.
- Thorough understanding and hands on experience of MSD platform is highly desirable.
- Solid understanding of relevant FDA, EU, and ICH regulatory guidelines and pharmacopeia as applicable to immunoassay method qualification/validation for biologics and vaccines, and demonstrated ability of applying the regulatory guidance to formulate practical solutions and phase appropriate analytical strategy.
- Experience in IND, NDA and BLA submission is preferred.
- Project management skills including the ability to manage project resource requirements (material, manpower, time, etc.), and ability to elevate relevant issues to project lead and line-management.
- Strong interpersonal skills; ability to communicate effectively both verbally and in written formats.
Reports to: Director, Method Transfer and Quality ControlLocation: San Carlos, CACompensation:The compensation package will be competitive and includes comprehensive benefits and an equity component.Salary Range: $189,000 – $197,000 (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>
