Associate Director – Analytical Development

Location: 
800 Dubuque Avenue
South San Francisco, CA 94080
United States
Job Posted Date: 
May 30, 2019
Opportunities: 
Full-time Positions
Population: 
Life Sciences

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 to Vice President - Process Sciences and Manufacturing.   Compensation and title will be commensurate with experience level.

Job Requirements: 

Responsibilities:

  • 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
How to Apply: 

If you are interested, please submit your CV to [email protected]

Location: 
Peninsula
California