Scientist

BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a Scientist to work for a leading San Diego biotechnology company.


Scientist


Responsibilities:
  • Develop and pre-qualify cell-based potency assays and antigen binding ELISA methods. 
  • Apply Design of Experiments (DOE) to identify and optimize critical assay parameters. 
  • Set stage-appropriate systems suitability and acceptance criteria. 
  • Utilize PLA 3.0 software to perform parallel line analysis (equivalence testing). 
  • Interview GMP CROs, negotiate quotes, and perform audits to evaluate technical capabilities. 
  • Manage CROs to ensure bioassay methods are transferred and qualified within timelines for GMP lot release testing. 
  • CRO oversight to ensure stability sample testing occurs within specified time frames, new critical reagent lots are qualified for use, and any deviations, investigations, or CAPAs are resolved. 
  • Monitor bioassay performance and trend GMP DS and DP batch stability data. 
  • Represent bioassay function at project CMC subteam meetings. 
  • Perform non-GMP potency assay sample testing to support program needs. 
  • Write Development reports, memos, and relevant CMC sections for regulatory submissions. 
  • Present work and effectively communicate progress at meetings. 

Requirements:
  • Ph.D. (or MS) in Cell Biology or a related scientific discipline with 3+ years of industry experience in the bioassay field. (title commensurate with experience) 
  • Extensive, hands-on experience in bioassay methods optimization, qualification, and validation. 
  • Prior experience auditing and managing GMP CROs for bioassay testing. 
  • Proficient at using JMP, Design of Experiments (DOE), and PLA 3.0 software. 
  • Knowledge of relevant ICH and USP chapters, GMP requirements, and industry best practices. 
  • Demonstrated capability to work with team members to troubleshoot and identify solutions. 
  • Prior experience working with ADCs or bispecific molecules is desirable. 
  • Ability to work effectively in a goal-oriented, fast-paced, matrixed team environment. 
  • Flexibility to contribute to other functional areas is desirable


  • Location: La Jolla
  • Type: Permanent
  • Job ID: RH35756412