Associate Director of Late-Stage Analytics and Bioassay Development

Location
La Jolla, California
Posted
Jul 15, 2019
Required Education
Bachelors Degree
Position Type
Full time

Synthorx is a biotechnology company using a novel synthetic biology platform for the discovery and development of transformational protein therapeutics. Using expanded Genetic Alphabet to drive the site-specific incorporation of non-natural amino acids, Synthorx creates therapeutic proteins capable of re-programming receptor interactions leading to potentially effective treatment of diseases. We are hiring a driven, resourceful, and collaborative Associate Director of Late-Stage Analytical and Bioassay Development to join our high-energy team and support biopharmaceutical development. The successful candidate will report to the Sr. Director of CMC Analytical & Formulation Development. He/She will lead the development of cell-based bioassay, immunoassay and biochemical assays for cytokines to support clinical development and regulatory filings. He/She will also have responsibility developing Late-Stage analytical strategies and overseeing their execution.  We are seeking a highly motivated and independent individual who can operate at a fast pace, adjust priorities, and manage aggressive timelines.

Key Responsibilities

  • Develop, optimize and validate of MOA-reflective potency assay(s) suitable for drug product release and stability testing 
  • Lead interactions with internal experts, external consultants and key opinion leaders, to identify traditional and non-traditional strategies for characterizing new classes of proteins and peptides inherent with our platform
  • Support process development, qualification and comparability studies in a late clinical stage products
  • Lead tech transfer of methods to QC labs at CROs or CMOs 
  • Support regulatory filings including INDs and BLAs 
  • Edit, review and approve transfer and qualification or validation protocols and reports
  • Lead efforts to define product characterization and comparability strategies bridging from early stage to late stage.
  • Establish specification for late-clincal and commercial products
  • Collaborate with Sr. Director of Late-Stage Process Development to link Critical Process Parameters to Critical Quality Attributes.
  • Recruit and develop talent for the assay development group and the entire CMC organization
  • Collaborate with other internal bioassay and Early-Stage Analytical groups and provide support to collaborating functional groups as needed
  • Enforce Synthorx lab safety policies and best practices at all times 

Required Qualifications

  • A minimum of a Bachelor's degree in a biochemistry, molecular biology or relevant discipline with at least 12 years of pharmaceutical or related industry experience or a Master's degree with at least 10 years of pharmaceutical or related industry experience or a PhD with 8 years of pharmaceutical or related industry experience 
  • Broad knowledge and hands-on experience with various biological methods, e.g. SPR, FACS, ELISA, MSD, plate reader, etc.
  • Experience with method development and/or supervision of method development in cell-based bioassays, immunoassays and binding assays
  • Experience of late-stage assay development, qualification, and validation in GxP environment.  
  • Experience in setting product specification and assay validation acceptance criteria with statistical analysis
  • Strong familiarity with cGMPs, GLPs, GDPs and ICH guidelines 
  • People management and collaboration with CROs and CMOs
  • Attention to detail and exceptional organizational skills
  • Ability to work in a team environment and seamlessly coordinate activities across internal teams.
  • Proactively plan and manage priority and timelines 
  • Excellent oral and written communication skills