We are seeking a Senior Scientist - Process Research & Development to provide technical expertise to drive the process development and manufacturing of a novel nanoparticle, and the coupling of a recombinant pMHC protein to the nanoparticle, to produce active drug substances (referred to as a Navacim). The role requires expertise in organic and protein chemistry, preferably with experience in nanoparticles, bioconjugation and/or nanomedicines. The Senior Scientist will develop and scale-up robust manufacturing processes to produce material for pre-GMP and clinical studies to support the Parvus therapeutic platform. This includes building a strong technical understanding of the process chemistry and its influence on the molecular characteristics of these novel therapeutic constructs. The role will then provide technical oversight to the manufacturing conjugation process at the CMO and follow batches through release and stability testing. The individual must also work closely with other CMC functions in Parvus to ensure timely support to, and alignment with, formulation and analytical development activities and stability studies. This position reports to Vice President - Process Sciences and Manufacturing. Compensation and title will be commensurate with experience level.
Responsibilities:
- Technical expertise and oversight for the conjugation of pMHC protein to Nanoparticles, and technical support to the process for making the novel Nanoparticle
- Drive the development and scale-up of the conjugation process, building a strong technical understanding of the process chemistry and structure of the Navacim Drug Substance
- Work closely with analytical development to align process capability with Drug Substance Quality attributes, to define testing requirements for release, stability and characterization
- Work closely with process and manufacturing CRO/CMOs to drive/coordinate activities, including technical transfer of the process to manufacturing
- Responsibilities in establishing and managing the timeline and budget for nanoparticle and conjugation development and manufacturing activities
- Work within the Parvus Development team, and with CROs/CMOs, to finalize documentation and authoring of quality records and regulatory filings as needed
- Work with Parvus Development team in overall planning and coordination for the CMC function within Parvus
Required Skills/Experience:
- Doctorate (Ph.D.) degree in organic chemistry, biochemistry, biomaterials, or a related field is preferred.B.S./M.S. with equivalent professional experience also considered
- Technical expertise in biochemistry and/or organic chemistry, with > 3 years of post-graduate experience in areas of nanoparticle, nanomedicine and/or bioconjugation
- Experience/interest in applying chemistry skills to develop and improve drug manufacturing processes, and to build a fundamental understanding of the process technology and its influence on the drug construct
- Expert knowledge in applying analytical testing to characterize nanoparticle and/or bioconjugation systems
- Experience developing specifications for biological therapeutic constructs, as well as testing and characterization strategies for IND filings, is a plus
- A basic understanding of requirements and Quality documentation as related to GMP manufacturing and testing, and ability/interest to contribute to regulatory filing content
- Ability to effectively work with CRO/CMOs to drive process development and manufacturing activities
- Capable of managing timelines and budget to support programs
- Work effectively in a small, virtual company
- Ability to travel ~20% of the time
If you are interested, please submit your CV to [email protected]
Organization Details
Drug candidates have also been identified for celiac disease with others in earlier stages of research. Parvus recently announced that it had entered into a worldwide collaboration and license agreement with Genentech covering three of these programs: autoimmune liver, IBD, and celiac. In support of our new partnership, Parvus is expanding rapidly to on-board the additional resources necessary to advance these programs to the clinic.
The Parvus management team combines decades of experience in start-ups and biopharma, with demonstrated success in commercializing drugs from the lab to the market. We are seeking extraordinary and ambitious individuals who share our drive and desire to transform medicine.