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 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. SutroVax has generated pre-clinical proof-of-concept with its broad-spectrum PCV when 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 antigen discovery effort and early-stage pipeline addressing other 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 Series B round in 2017 and is financed by an international syndicate of experienced, blue-chip venture capital and corporate venture investors with $88M in capital raised since inception.
Summary / Essential Functions:
SutroVax is looking for an energetic and talented individual to play a key role in the Formulation Development function within Process Development. The successful candidate will be versed in the formulation development cycle of biological molecules. SutroVax is focused on the development of protein conjugate vaccines. Hence, the successful candidate will ideally not only have experience formulating proteins, but also have experience formulating complex mixtures such as adjuvanted polysaccharide-carrier proteins. The successful candidate will lead the experimental design, execution and output of the required scientific studies to progress the vaccines through the research development cycle and into early clinical trials. Such studies may encompass:
- Nomination of drug substance (DS) and drug product (DP) formulation matrix through accelerated thermal stability and handling studies,
- Generating a deep biophysical characterization package of the molecular entities,
- Development, with ongoing support, of clinical scale DP processing methodologies.
This position will report to the Director of Formulation and be part of the wider Process Development and Manufacturing group. The role may also have significant contact with contract manufacturing organizations (CMOs), thus a highly collaborative approach to cross-team project delivery will be engendered. In addition, significant partnerships with the Research, Analytical and Process Development teams is also essential. In conjunction with these teams, supply of toxicological and early clinical materials, with associated regulatory documentation, will ensue. This role will lead the scientific package of work for successful clinical execution.
The role will require the incumbent to be comfortable working in an independent, but supported manner. Flexibility of time management and agility in the thought process will be essential to accomplish the differing facets of various vaccine projects. This position may have a limited number of direct reports.
This is a hugely exciting time in SutroVax’s growth and this position will play a key role in delivering clinical materials and driving the success of the company.
- PhD in Pharmaceutical Sciences, Biochemistry, Chemical / Biochemical Engineering, or a related discipline, with 5+ years of industry experience; MS or BS with 10+ years of industry experience
- Expertise in the development of the formulation to allow matrix nomination, leading to DP process development for clinical manufacture of parenteral formulations (e.g., proteins, peptides, ADCs, viral particles, vaccines); preferably experience formulating adjuvanted vaccines.
- Experience in the characterization of adjuvanted vaccine systems a distinct advantage. Proficiency running gel and column-based analytical methods is also a plus; such methods may include CE-SDS, icIEF, SEC-HPLC/MALS, HIC/IEX/RP-HPLC.
- Experience in high throughput methodologies of formulation screening and DoE (Design of Experiments) for formulation development preferred. Supporting statistical analysis would be expected.
- Experience in developing DP manufacturing unit operations (e.g., filtration/mixing studies) would be of significant benefit.
- A thorough understanding of GLP/GMP; with experience of generating DP materials for toxicology or clinical studies preferred.
- Experience working with CMOs preferred; ability to effectively transfer formulation processes to external teams and assist in troubleshooting in conjunction with the CMO. This may require some occasional travel.
- Experience in designing and performing research stability protocols is required. This will be followed by data interpretation and presentations to local and senior management. Data will be summarized in formal documentation.
- Experience and success in managing direct reports.
- Highly efficient and structured work practices including practical laboratory work, notebook upkeep, data generation and presentation to the Formulation and wider teams.
- Demonstrated ability to work collaboratively in a cross-functional team environment on multiple projects
- Strong interpersonal skills, with excellent written and verbal communication skills
Reports to: Director, Formulation Process Development
Location: Foster City, CA
The compensation package will be competitive and includes comprehensive benefits and an equity component.