Associate Director, Combination Device and Late-Stage Drug Product Development
San Carlos, CA, USA
Posted on Friday, May 19, 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.
VAX-24 and VAX-31 are extremely complex biologics whereby numerous Drug Substances are presented as an adjuvanted suspension DP. The complexity of the DP necessitates careful consideration for development of a pre-filled syringe (PFS) combination product for clinical ph3 and ultimate commercial use. Vaxcyte is looking for an energetic and talented individual to join our Drug Product (DP) Development team to drive the combination product through the stages required for commercial success.
This is an SME position which is suited for someone who has significant late-stage experience in leading the technical combination product workstream for a PFS/Biologic combination product. Experience with combination product Design Control requirements and generation of completed Design Control documentation is required. As a core member of the DP Technical Team they will work closely with internal Technical and CMO/QC/QA/Clinical Teams to ensure the appropriate Device Design requirements, including Verification and Validation Testing are met for use of the combination product in ph3 clinical studies and marketing applications. They will work closely with the Regulatory and Quality Teams to ensure the appropriate 21 CFR Part 4 and 820.3 compliant documentation is produced to support both clinical studies and marketing applications.
In addition, there will be future scope for this individual to be involved in additional late-stage development activities of the DP program(s). This may include down-scale Process Characterization planning and execution, in-house Pilot scale production(s) and at-scale PPQ planning and execution. In addition, phase 3 DP campaign preparation, scale-up activities, and management of GMP productions at the DP CMO could be foreseen.
This is a unique opportunity to be involved in arguably the most complex Drug Product to enter clinical testing, be a crucial part of ph3 enablement and long-term commercial success of the product, which will affect millions of lives globally.
- Leading the Design Control process in the context of CMC requirements for VAX-24 and VAX-31 phase 3 regulatory submission content.
- Guide the DP team on the necessary technical/CMC requirements for compliance with 21 CFR Part 4 and Part 820.3 and implement into the Combination Product program plan.
- Build the required Design Control documentation with VAX-24/VAX-31 specific content, including appropriate SOPs, DDP, Design Input/Output Requirements, URS, Verification and Validation testing protocols/reports, FMEAs etc.
- Collaborate with numerous external Team members to build the phase appropriate DHF and DMR including, Program Management, Clinical, Regulatory, QA, QC, component suppliers and DP production CMO.
- Manage suppliers of PFS components and ensure the supply chain is in place for clinical production.
- Interact with the DP Technical Team and advise on late-stage development strategies for successful execution of Process Characterization studies and PPQ campaigns.
- Support the DP Technical Team in tech transfers of the process(es) for both late and early-stage programs to CMOs.
- BSc or MSc in Pharmaceutics, Chemistry, Biochemistry or Engineering preferred, with >8 years of industrial experience; or PhD in Pharmaceutics, Chemistry, Biochemistry or Engineering with >5 years of relevant experience.
- The candidate should have significant experience in managing and executing Design Control programs with biological molecules for combination products, preferably PFSs.
- Experience with vaccines and/or suspension products would be a distinct advantage.
- Experience of manufacturing within GxP environments either directly or through CMOs .
- Preferred experience in late-stage DP development, designing and executing PPQ protocols, ensuring that drug product manufacturing processes are robust, reproducible, and meet regulatory requirements. This would include conducting risk assessments, identifying critical process parameters, and overseeing process validation activities for suspension DPs.
- The candidate should have a track record of working seamlessly within and across Teams and Organizations to execute the Design Control process.
- Strong scientific leadership is required: critical thinking, ability to present complex data sets and to independently propose and design follow-up studies.
- High degrees of both flexibility and organizational skills as well as an eagerness and ability to learn in order to effectively navigate multiple projects and timelines.
- Strong interpersonal skills; ability to communicate effectively both verbally and in written formats are necessary to collaborate effectively with the rest of the Formulation and DP technical team and well as across other teams.
- Detail oriented, rigorous and excellent skills in record keeping/documentation.
- All Vaxcyte employees require vaccination against COVID-19.
Reports to: Senior Director of Formulation & Drug Product Development
Location: San Carlos, CA
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $176,000 - $190,000
Send resumes to:
825 Industrial Road, Suite 300
San Carlos, CA 94070
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