Associate Director, Analytical Development, Raw Materials
San Carlos, CA, USA
Posted on Friday, October 27, 2023
Vaxcyte, Inc. (Nasdaq: PCVX) is a vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. The Company is developing broad-spectrum conjugate and novel protein vaccines to prevent or treat bacterial infectious diseases. Vaxcyte’s lead candidate, VAX-24, is a 24-valent, broad-spectrum, carrier-sparing pneumococcal conjugate vaccine (PCV) being developed for the prevention of invasive pneumococcal disease (IPD). The Company is re-engineering the way highly complex immunizations are made through modern synthetic techniques, including advanced chemistry and our exclusively licensed XpressCFTM cell-free protein synthesis platform. Unlike conventional cell-based approaches, the Company’s system for producing difficult-to-make proteins and antigens is intended to accelerate its ability to efficiently create and deliver high-fidelity vaccines with enhanced immunological benefits. Vaxcyte’s pipeline also includes VAX-31, a 31-valent PCV candidate; VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease; and VAX-GI, a vaccine program designed to prevent Shigella. The Company is driven to eradicate or treat invasive bacterial infections, which have serious and costly health consequences when left unchecked. For more information, visit www.vaxcyte.com.
Vaxcyte, headquartered in San Carlos, CA, went public in June 2020 and currently has a team of approximately 180 employees and anticipates continued, significant growth. Following equity offerings in October 2022 and April 2023, which generated over $1.1 billion in net proceeds, the Company’s balance sheet is further strengthened to advance its pipeline of novel vaccines, including VAX-24. These financings followed positive data readouts from Vaxcyte’s Phase 1/2 proof-of-concept study evaluating VAX-24 in adults aged 18-64 and Phase 2 study in adults 65 and older. The Company believes these results support a best-in-class potential for VAX-24, which was designed to replace the current standard-of-care in adults and children. VAX-24 is being investigated for the prevention of IPD, which can be most serious for infants, young children, older adults and those with immune deficiencies or certain chronic health conditions. Given the global impact of pneumococcal disease remains significant, the public health community continues to advocate for vaccines that can offer broader protection to prevent IPD. Vaxcyte’s PCV franchise, consisting of VAX-24 and VAX-31, is designed specifically to address this need and has the potential to deliver the broadest protection for this very serious disease. We believe that our PCVs could receive regulatory approval based on successful completion of clinical studies utilizing well-defined surrogate immune endpoints, consistent with how other PCVs have obtained regulatory approval in the past, rather than requiring clinical field efficacy studies.
Vaxcyte is looking for an accomplished, driven, energetic and pragmatic leader with extensive analytical development experience, to join Vaxcyte’s Analytical Development & QC organization as Associate Director (AD) of Analytical Development for Raw Material.
This pivotal role will spearhead analytical method development for raw materials, serving as the analytical technical leader for all analytical activities related to raw materials within the company and a complex network of approximately 10 Contract Development and Manufacturing Organizations (CDMOs). These raw materials encompass a diverse range, including small molecules, enzymes, complex cell extracts, plasmid DNAs, and more—a list that continues to expand. Consequently, there is a broad scope of analytical technologies used, and expertise with analytical methods used in assays for these raw materials or the ability to quickly adapt to them is crucial.
This role is primarily outward-facing, where you will play a critical role in method development, transfer, and validation. The Associate Director of AD for the Raw Material will review all raw material-related analytical and QC documents to ensure their accuracy and quality. The role will also be responsible for establishing raw material analytical control systems and ensuring the timely completion of critical deliverables. Your leadership will be instrumental in resolving technical, compliance and cross-functional issues and determining priorities for Project Management (PM) and other ADQC project team members, ultimately contributing to the success of our projects.
This role offers a unique opportunity to lead and shape company’s raw materials program, both internally and within our network of CDMOs. You will have a significant impact on the technical quality of our projects and contribute to our company's continued success.
- Provide strategic, tactical, and technical leadership in the development and improvement of a broad range of analytical methods for raw material to support pre-clinical and clinical projects.
- Serve as the analytical technical leader for method transfer, method validation, and other QC activities within the CDMO network.
- Ensure methods developed internally or through CDMOs are technically solid, suitable for their intended purpose and robust.
- Review and approve all raw material-related analytical and QC documents, the weekly document review workload averages of 30-40 analytical documents.
- Responsible for the accuracy and quality of 50+ analytical raw material methods and many analytical quality documents, ensuring alignment among various ADQC functions.
- Collaborate with Vaxcyte QC and CMO QC team to design the raw material method validation protocols and set phase appropriate data-based acceptance criteria.
- Provide technical direction, mentorship and coaching to a small in-house analytical development team, with the expectation of team expansion as projects progress to late stages.
- Provide technical support to Vaxcyte QC team to ensure smooth transfer of methods to the GMP test sites, lead investigation and studies for troubleshooting of QC testing, method qualification/validation or method related issue.
- Evaluate and establish contracts with new CDMO for raw material method development and testing when necessary.
- Lead the establishment of analytical control systems for raw materials, provide clear rationale and supporting data to gain the CMC team endorsement of the decision.
- Highly skilled, motivated, energetic, and pragmatic leader who thrives on challenges and who is excited by the prospect of making a meaningful impact within a forward-thinking organization.
- Must be a strong technical leader who can guide project teams at CDMOs and internal team with clear goals of implementing and validating analytical methods, with critical and skillful review and assessment of analytical methods.
- Strong Analytical Technical Knowledge: Success in this position hinges on a deep understanding of analytical methodologies, including the ability to grasp and apply various analytical methods swiftly. A robust foundation in analytical science is essential for making informed decisions and ensuring the accuracy and quality of analytical activities.
- Adeptness in Learning: Given the broad range of molecular structures and analytical methods involved, the ability to quickly learn and adapt to new techniques and technologies is paramount. Your capacity to stay on top of principles and key details of over 50 continuously growing analytical methods, and swiftly integrate this method knowledge into your daily decision making and problem solving is vital.
- Critical Document Review: With the responsibility of reviewing and approving hundreds of QC documents, meticulous attention to detail and the capacity to critically assess data and reports is non-negotiable. Ensuring the highest standards of quality and compliance relies on your thorough and discerning approach.
- Strong Problem-Solving Skills: You must possess strong and pragmatic problem-solving skills to address the multifaceted challenges that arise in the internal and CDMO Analytical Development and QC organizations during method development, transfer, method qualification/validation and QC testing. The ability to navigate complex issues with innovative solutions is a cornerstone of this role.
- Good Judgment and Decision-Making: The role necessitates making critical decisions that impact raw material quality, compliance, and project timelines, which has direct impact on company strategic goals and milestones. Sound judgment and decision-making abilities are imperative to guide the team and ensure the company's QC and manufacturing objectives are met.
- PhD in Chemistry, Analytical Chemistry, Biochemistry, or related field with 7+ years relevant industry experience; MS or BS with 12+ years of industry experience in Pharma / Biotech industry required.
- Ability to collaborate effectively across functions and with external stakeholders.
- In-depth expertise in U/HPLC, CE, mass spectrometry, GC, colorimetric and other analytical technologies as applied to small molecules, polysaccharides, proteins, conjugates, and adjuvanted drug product vaccines. Skilled in analytical method development, trouble shooting, and validation for GMP lot release and stability testing.
- Strong knowledge of regulatory requirements and quality standards in the pharmaceutical industry.
- Good organization and planning skills.
- Excellent technical writing skills and direct experience in authoring method SOPs, validation protocols and reports, and regulatory filings.
- Ability to work in a fast-paced team environment, and to consistently meet aggressive timelines while prioritizing tasks for multiple projects.
- Strong written and verbal communication skills, and efficient in communicating to inter-disciplinary and cross-functional teams.
- Familiarity with FDA, ICH, EMA and other regulatory agency guidance associated with release and characterization assays.
- All Vaxcyte employees require vaccination against COVID-19.
Reports to: Vice President, Analytical Development & Quality Control
Location: San Carlos, CA
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $182,000 – $188,000
Send resumes to:
825 Industrial Road, Suite 300
San Carlos, CA 94070
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.