Scientist I, Stability
San Carlos, CA, USA
Posted on Friday, November 3, 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 energetic and talented individual to join our Analytical Development and Quality Control Team
The Stability Scientist will assume the critical role of design, plan, execute and coordinate stability studies on development and clinical lots, summarize and analyze results to ensure scientific and technical excellence. Collaborating closely with cross-functional teams, the scientist will play an integral part in guaranteeing the quality, safety, and adherence to regulatory standards of our products. This position is for a scientific role which will be mostly lab based, which will require excellent scientific judgement, independence, rigor and thorough record keeping.
The primary responsibility for the incumbent will be to support development stability activities of Vaxcyte’s lead product candidate from early-stage development through Phase 3 and culminating in BLA filing and commercial manufactures.
- Initiate and manage vaccine Stability Program activities. Including authoring of internal Vaxcyte Stability Protocols. Reviewing all stability data – conducting basic trending and statistical analysis for extrapolation.
- Support development activities such as stability studies for thermal, freeze/thaw, photostability, and new container closure system evaluation for both Drug Substance (DS) and Drug Product (DP) materials.
- Support in product investigations, working with cross functional teams for investigations related quality issues, deviations, out-of-specification results, and anomalies at all stages of vaccine development, from early development to late-stage phases.
- Support coordination of sample distribution and management of data results. Organize and train new personnel on new and emerging stability processes, provide guidance on these techniques to other technical staff.
- Contribute to the creation of stability data presentations for various key stakeholder meetings.
- Preparing written summaries of data analyses including figures, tables, as needed for technical reports, scientific papers and patent application.
- Documentation: Maintain thorough and accurate records of laboratory work
- Ensure good scientific and technical leadership within the group, keep updated with current developments in relevant scientific and technical disciplines.
- Communication: Effectively communicate investigation findings and progress to both internal teams and external stakeholders as necessary.
- Collaborate with external Contract Development Manufacturing Organizations (CDMOs) to facilitate the testing of stability samples, providing essential support for investigative processes.
- Ph.D. or Master's degree in a relevant scientific field (e.g., pharmaceutical sciences, biophysics, biochemistry, or related discipline) is preferred.
- At least 3-5 years of experience in vaccine analytical development and/or vaccine stability program development
- Strong analytical skills, with proficiency in a range of analytical techniques
- Strong scientific leadership is required: critical thinking, ability to present complex data sets and to independently propose and design follow-up experiments.
- The candidate should have high degrees of both flexibility and organizational skills as well as an eagerness and ability to learn in order to effectively navigate Vaxcyte’s multiple projects and timelines.
- Strong interpersonal skills: ability to communicate effectively both verbally and in written formats (must be able to work with managerial and lab team in remote setting when needed) are necessary to collaborate effectively with the rest of the Analytical Development and Quality Control 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: Director, Stability
Location: San Carlos, CA
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $120,000 – $128,000
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.