PaxVax develops, manufactures and commercializes innovative specialty vaccines against infectious diseases for traditionally overlooked markets such as travel. PaxVax has licensed vaccines for typhoid fever (Vivotif) and cholera (Vaxchora), and vaccines at various stages of research and clinical development for adenovirus, anthrax, hepatitis A, HIV, and zika. As part of its social mission, PaxVax is also working to make its vaccines available to broader populations most affected by these diseases. PaxVax is headquartered in Redwood City, California and maintains research and development and Good Manufacturing Practice (GMP) facilities in San Diego, California and Bern, Switzerland and other operations in Bermuda and Europe.
PaxVax offers competitive compensation along with a generous benefits package that includes fully covered employee medical and dental benefits, 401k, life insurance, Short Term Disability (STD) & LTD coverage.
PaxVax is proud to be an E-Verify employer. E-Verify is an Internet based system operated by the Department of Homeland Security (DHS) in partnership with the Social Security Administration (SSA) that allows participating employers to electronically verify the employment eligibility of their newly hired employees in the United States. Please review our Everify posters for more information.
Please find our available positions below. Please submit your cover letter and resume to email@example.com with the position title in the subject line.
The Sr. Production Associate is responsible for commercial production of PaxVax's Vaxchora vaccine, which includes blending and filling processes at the San Diego site. This position reports directly to the Director of Process Development and Production.
The Senior Scientist position will assume a leadership role focused on supporting Analytical Development and company pipeline objectives. The candidate will actively design, carry out, and evaluate analytical activities to advance preclinical/clinical stage novel vaccines through development, regulatory submission and approval, as well as supervise a team of scientists engaged is method development and GMP testing activities. Assure timely, appropriate method development, validation and implementation to meet project target profiles and ICH, USP, FDA, and EMA standards through a combination of internal and contracted activities. Vaccine projects will include a broad range of methods for characterization and quality control requiring strong competencies in cell-based and molecular techniques, both compendial and novel, applied to in-process materials, drug substance, and drug product. The Candidate must be able to effectively communicate results and issues to management and customers, internal and external, with excellent professional standards.
The Senior Associate, Production is responsible for clinical production of PaxVax's various viral vaccine products, which includes suspension cell culture in bioreactor, purification and diafiltration/ultrafiltraton, lyophilization and pan coating processes. This position reports directly to the production supervisor.
The Scientist, Process Development (Purification) is responsible for process development of PaxVax's various viral vaccine program, which includes suspension cell culture in bioreactor, purification and diafiltration/ultrafiltraton, lyophilization processes. This position reports directly to the director of process development and production.
The Research Associate will be responsible for pre-clinical and clinical assay development, qualification, and execution. This is a unique position that requires the understanding and application of both existing and new scientific methods and knowledge in accordance with GxP standards. Experience with cell-based multi-well plate bioassay formats for virus titration, virus neutralization, and immunoassays such as ELISA/ELISpot is preferred. Prior experience using flow cytometry, pre-clinical animal models, or protein/virus purification is a bonus.
Responsible for operating standardized scientific procedures and techniques in a highly regulated environment (GMP/GLP compliant) for clinical research applications; contributes to the planning, design, execution and interpretation of clinical and pre-clinical assay optimization experiments (assay development); makes detailed observations, records data, as well as assesses the processes and results for reliability, efficacy, and compliance. Must be able to multi-task, adapt, and be flexible to a fast paced and demanding environment. Organization and accountability is key. Will work closely with and report to the clinical assay project lead to ensure delivery of project specific demands and requirements.
PaxVax is looking to recruit an experienced professional into the role of Regulatory Affairs Manager. The purpose of this role is:
- Global RA operational function including the compilation, publishing, submission and archiving of all variations.
- Implementation of RA processes that are scalable, including eCTD submissions.
The Quality Assurance Manager, Compliance will be assisting the head of the Quality Systems Compliance group with monitoring the overall performance of the quality systems at PaxVax in San Diego and the assessment of key quality outputs, such as deviations, change controls, complaints, audits, non-conformances, and out-of-trends (OOT). In this role, s/he will conduct both internal and external audits as the lead auditor, write audit reports and Quality SOPs, conduct cGMP trainings, manage the training program, and assist with the maintenance of the documentation system as well as with trending of Quality metrics.
The Principal Associate position will focus on developing, qualifying, and validating new methods in support of PaxVax vaccine development programs. The candidate will also perform release and stability testing of pipeline candidates through all phases of product development. Experience working in a GMP laboratory environment, as well as a detailed knowledge of analytical requirements for parenteral and oral products is required. Experience with biomolecular methods, including cell-based, immunological, and molecular biological assays, as well as standard laboratory techniques (Karl Fisher, pH determination, spectroscopic methods etc.) is also required.
The Quality Assurance (QA) Manager is expected to bring in-depth experience in drug substance and drug product manufacturing. Reporting to the Director, Quality Assurance, the QA Manager will provide Quality oversight and support to the Operations group for the manufacture and testing of non-clinical, clinical and commercial products. The QA Manager will be accountable for driving Quality initiatives, maintaining/improving quality infrastructure and participating where needed on various CMC related project teams. The QA Manager will be accountable for assuring compliance with Quality System, quality oversight at the project level and assuring the quality of materials manufactured and data generated.
The Manager, Clinical Operations will be responsible for the planning and efficient conduct of the clinical operations of the vaccine research and development programs. The Manager provides leadership and supervision for the Clinical Research Associates and Clinical Program Managers, and serves as a technical and scientific resource in the conduct of Phase I to Phase IV Clinical Trials.