Senior Scientist, Analytical Development
SutroVax is a biopharmaceutical company dedicated to the delivery of best-in-class conjugate vaccines and novel complex antigen-based vaccines to prevent serious infectious diseases. SutroVax’s lead product candidate is a pneumococcal conjugate vaccine (PCV) that is designed to prevent invasive pneumococcal disease (IPD) caused by Streptococcus pneumoniae. SutroVax’s broad-spectrum PCV is designed to provide expanded protection against circulating strains of pneumococcus and has the potential to replace the current vaccines used in infants and adults. The current mainstay vaccine only covers approximately 40% of the circulating strains causing IPD yet generates $6B in annual sales. SutroVax has generated positive pre-clinical proof-of-concept with its significantly broader-spectrum PCV compared head-to-head to current vaccines using well accepted immunological endpoints. In addition to its lead PCV product candidate, the Company also has a promising early-stage pipeline addressing other important disease areas.
SutroVax’s conjugate vaccines are developed utilizing the Company’s exclusive rights to Sutro Biopharma’s Xpress CF Platform, a cell-free protein synthesis technology. SutroVax closed its $85M Series C round in May of 2018 and is financed by a world-class syndicate of private equity, venture capital and corporate venture investors with over $170M in capital raised since 2015.
SutroVax is looking for an energetic and talented individual to join our Development team. The candidate will independently develop analytical methods (including but not limited to: different modes of chromatography, spectrometry such as MS and NMR, CE, colorimetric and light-scattering technique) and perform sample testing to support development and formulation of protein and conjugate vaccine targets. The successful candidate will also provide scientific mentorship and technical guidance for junior colleagues in analytical method development. Additional responsibility will also include analytical data review, authorship of protocols and reports, coordination and oversight during assay transfer between our company and external partner groups.
- Independently lead the development, qualification, and transfer of analytical methods for purity, content, and other quality attributes of biologic drug substances, carbohydrates, and vaccine targets
- Develop analytical methods and conduct characterization studies to support formulation development and the establishment of appropriate manufacturing control strategies
- Perform analytical method transfer to CROs/CMOs
- Perform appropriate CRO/CMO oversight by reviewing analytical method development data, reviewing and approving analytical method validation protocols and subsequent reports, and reviewing and approving analytical method SOPs
- Provide technical oversight to drug substance/drug product release and stability testing, as well as trouble shooting and analytical investigation at CRO/CMOs
- Author protocols, reports, and regulatory submissions as appropriate
- PhD in Chemistry, Analytical Chemistry preferred, Organic / Biochemistry considered, with 3+ years relevant industry experience; MS or BS with 10+ years of industry experience; (Pharma / Biotech / Analytical Testing) required
- Ideal candidate will have a strong theoretical understanding of various analytical chemistry methodology principles and successful track record of method development trouble shooting and validation.
- Extensive hands-on experience with modern analytical instrumentations commonly used in the analysis and characterization of biologics, carbohydrates, conjugates and small molecule drug candidates
- Direct experience operating Agilent HPLC using OpenLab/Chemstation software and/or Waters UPLC and Empower software for data acquisition and analysis
- Experience working in a regulated (GLP / GMP) environment
- Solid understanding of relevant FDA, EU, and ICH regulatory guidelines and pharmacopeia as applicable to analytical method development and qualification/validation for small molecules, biologics and vaccines, and demonstrated ability of applying the regulatory guidance to formulate practical solutions and phase appropriate analytical strategy
- Attention to detail and excellent skills in record keeping / documentation
- Extensive technical writing experience in drafting method protocols, SOPs and reports
- Project management skills including the ability to manage one’s project resource requirements (material, manpower, time, etc.), and ability to elevate relevant issues to project lead and line-management.
- Strong interpersonal skills; ability to communicate effectively both verbally and in written formats
- Self-starter; ability to work in a fast-paced, cross-functional environment and collaborate effectively with other team members
Reports to: Senior Director, Analytical Development & Quality Control
Location: Foster City, California
The compensation package will be competitive and includes comprehensive benefits and an equity component.