Sr. Scientist, Drug Product Development SME
San Carlos, CA, USA
Posted on Saturday, November 4, 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 Formulation and Drug Product Development team.
The Scientist II Drug Product Development SME will assume the critical role of overseeing and executing investigations while developing and deploying strategies aimed at resolving a range of product-related challenges, extending from the initial stages to the more advanced phases of drug product development. This role will primarily center on the domain of aluminium salt adjuvanted vaccine drug products. Collaborating closely with cross-functional teams, the Sr. 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. In addition, this role will require significant expansion and deepening of our core and scientific understanding of the highly complex drug products under development, achieved through collaboration with external academic and commercial partners.
The primary responsibility for the incumbent will be to support formulation drug product development activities of Vaxcyte’s lead product candidate from early-stage development through Phase 3 and culminating in BLA filing and commercial manufactures.
- Product Investigations: The candidate will play a pivotal role in leading and conducting extensive investigations related to quality issues, deviations, out-of-specification results, and anomalies at all stages of vaccine drug product development, from early development to late-stage phases. These investigations will rely on the robust application of Design of Experiment (DoE) methodology and the utilization of a wide array of analytical techniques. A core requirement for the candidate is a deep understanding of the mechanisms of degradation and stability of biomolecules.
- Product Knowledge: The candidate will be responsible for strategically expanding our knowledge base, ensuring that our understanding of these complex drug products is not only deep but continually broadening. The candidate should be a creative problem solver, capable of identifying challenges and developing innovative solutions to overcome scientific hurdles in drug product development.
- Data Analysis: Analyse, interpret, and report on investigation findings, identifying root causes and proposing corrective and preventive actions.
- Documentation: Maintain thorough and accurate records of investigations, including reports, test results, and documentation of all activities performed.
- Regulatory Compliance: Ensure all investigations are conducted in accordance with regulatory requirements and company SOPs, contributing to the development and maintenance of compliance standards.
- Support formulation development activities, including stability studies for thermal, freeze/thaw, and agitation, kinetic analysis of antigen degradation as well as container closure system evaluation for both Drug Substance (DS) and Drug Product (DP) materials.
- Process Improvement: Identify opportunities for process improvements and optimization in early and late-stage product investigation procedures.
- 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 drug products, providing essential support for investigative processes.
- A Ph.D. or Master's degree in a relevant scientific field (e.g., pharmaceutical sciences, biophysics, biochemistry, or related discipline) is preferred.
- Preferable at least 3-5 years of experience in vaccine drug product development and product investigation, with a focus on adjuvanted vaccine drug products.
- Strong analytical skills, with proficiency in a range of analytical techniques such as MSD, ELISA, Laser diffraction, liquid chromatography and adjuvant antigen binding characterization.
- The candidate should have experience in the use of statistical analysis and Design of Experiments (DoE) for complex system optimization.
- Experience with biophysical and calorimetric methodologies applied to proteins and protein polysaccharide conjugates such as Circular Dichroism, Fourier Transformed Infrared (FTIR) Spectroscopy, Fluorescence Spectroscopy, Differential Scanning Calorimetry (DSC) and Isothermal titration calorimetry (ITC) would be a distinct advantage.
- 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 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 Formulation and Drug Product Development 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, Formulation Development
Location: San Carlos, CA
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $144,000 – $160,000
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.