Associate Scientist, Process Analytical Sciences

6084-Janssen Research & Development Legal EntityMalvern, PA
Onsite

About The Position

The Associate Scientist, Process Analytical Sciences (PAS), is part of the Analytical Development (AD) Proteins organization and is responsible for accelerating large-molecule development by delivering phase-appropriate analytical testing at scale—combining high-throughput methods, automation, and streamlined data workflows to meet program timelines. You will be responsible for conducting execution of protein-based analytical assays for biologics drug development to quantify size variants, excipient content, charge variants, bioactivity, etc. You will also troubleshoot instrumentation issues; perform root-cause investigations with SMEs/vendors and implement corrective actions. Thrive in a team setting in a dynamic environment, contribute technical expertise to multiple large molecule programs, be proficient with documentation, and review of analytical data. Train and mentor end-users to run and maintain laboratory equipment; publish results and standard processes to build shared capability. Being technical lead and execute method development and routine testing/reviewing as per the procedures and methods in place within Non-GMP and GMP environments.

Requirements

  • Minimum of a bachelor’s degree in chemistry, biology, biochemistry, engineering, or related scientific/technical field with 0-3 years of relevant industry experience.
  • Experience working in cross-functional environments, effectively collaborating with analytical scientists, engineers, digital/data teams, and external vendors.
  • Strong background in multiple protein-based technologies (e.g. cIEF, CE-SDS, ELISA, cell-based assays, HPLC/UPLC, etc.)
  • Good written and verbal communication skills are required.

Nice To Haves

  • Demonstrated ability to train and mentor others, create standard work, and build sustainable technical capability within a team environment.
  • Strong communication, organization, and project management skills, with the ability to prioritize work and deliver against timelines in a dynamic environment.
  • Familiarity with regulated environments (e.g., GMP/GxP) and supporting documentation, validation, and data integrity requirements.
  • Familiarity with lab automation and automation workflow (i.e. TECAN, Hamilton, etc.)
  • Familiar with data acquisition software and processing (e.g. Empower, Chemstation, etc.)

Responsibilities

  • Conduct execution of protein-based analytical assays for biologics drug development to quantify size variants, excipient content, charge variants, bioactivity, etc.
  • Troubleshoot instrumentation issues; perform root-cause investigations with SMEs/vendors and implement corrective actions.
  • Contribute technical expertise to multiple large molecule programs, be proficient with documentation, and review of analytical data.
  • Train and mentor end-users to run and maintain laboratory equipment; publish results and standard processes to build shared capability.
  • Be technical lead and execute method development and routine testing/reviewing as per the procedures and methods in place within Non-GMP and GMP environments.
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