Associate Director – Analytical Development
CMC: We are seeking an Associate Director – Analytical Development to lead the development of analytical methods for a class of recombinant pMHC proteins and an active drug substance referred to as Navacims, where the pMHC protein is coupled to a nanoparticle. The development of these methods represents a significant technical challenge given the novelty of the pMHC proteins and Navacims. The scope includes establishing a complete network of assays to release and characterize the pMHC proteins and Navacim drug substances and products for clinical use. This will be accomplished by collaborating with Parvus research to establish selected novel biological assays, as well as driving transfer of assays and all development activities through a virtual CRO/CMO network. After development, methods will be qualified and validated at CRO/CMOs as needed for Quality Control testing to enable GMP manufacturing or used for characterization testing in support of regulatory filings. The Associate Director will oversee the progression of the methods from the concept phase to their end use as a QC or characterization method. The Associate Director will also work closely with other Parvus CMC functions in process and formulation development to ensure timely support of these activities and alignment of methods with process and stability requirements. This individual must have the ability to quickly understand business and technical issues, and to build effective plans to mitigate risk and ensure timely progress and successful completion of analytical development and testing activities. This position reports toVice President – Process Sciences and Manufacturing. Compensation and title will be commensurate with experience level.
Location: South San Francisco, CA
Parvus Therapeutics is pioneering a breakthrough class of disease-specific, non-immunosuppressive biologics called NavacimsTM that are designed to halt and potentially cure autoimmune disease and other inflammatory disorders by restoring immune tolerance. The Navacim technology platform is generating a rich pipeline of therapeutic candidates to address a wide range of inflammatory diseases. Our most advanced programs target Type 1 Diabetes (T1D) (partnered with Novartis) and autoimmune liver diseases. POC and efficacy in animals has been established not only for these two programs but also for multiple sclerosis (MS) and inflammatory bowel disease (IBD).
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.
- Technical oversight of analytical development for pMHC proteins, Navacims (pMHC linked to Nanoparticle) and Drug Product
- Deliver expert, in-depth knowledge to analytical methods for proteins and nanoparticle-protein constructs, including complete array of assays needed for drug development
- Development of analytical testing to characterize and release pMHC protein, Navacims and Drug Product. This includes method establishment, development and qualification/validation as required for GMP manufacturing
- Work with QC and other functions within Parvus to give technical oversight for release and stability testing of manufacturing batches and reference standards
- Establish/maintain/lead relationships with analytical CRO/CMOs to drive the timely advancement of analytical development
- Responsibilities in establishing and managing the timeline and budget for analytical development and testing within the Parvus development team
- Interface with Parvus collaboration partners to ensure understanding and alignment in analytical development, characterization and testing
- Work within the Parvus Development team, and with CROs/CMOs, to finalize development, qualification/validation and testing documentation for quality records and regulatory filings associated with analytical development and testing
- Author regulatory sections related to protein, Navacim and Drug Product structure and testing results
- Work with Parvus Development team in overall planning and coordination for the CMC function within Parvus
- Doctorate (Ph.D.) degree in biochemistry, chemistry, or the biological sciences is preferred. S./M.S. with equivalent professional experience also considered
- Strong technical expertise in biologics analytical development, including at least 5 years of experience in the development of assays of biologically derived constructs for in vivo use
- Technical expertise in the development of general methods used in CMC drug testing
- Expertise in the analysis of protein conjugation systems and/or nanoparticle/nanomedicine constructs is a plus
- Experience establishing, optimizing, developing and qualifying/validating assays for QC testing in support of GMP manufacturing
- Familiarity with applying analytical testing to formulation screening, process development and stability studies
- Experience developing specifications for biological therapeutic constructs, as well as testing and characterization strategies for IND filings
- An understanding of GMP requirements and Quality documentation as related to QC testing, and experience preparing documentation for quality systems and regulatory filings
- Experience effectively working with and managing CRO/CMOs for analytical development and testing
- Ability to manage development timelines and budget to support programs
- Capable of working effectively in a small, virtual company, and executing a development plan through a third party CRO network
- Ability to travel ~20% of the time
Parvus Therapeutics is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Parvus is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment.
(Req # 1200-15)
No relocation offered-local candidates only