Scientist II, LC Development, Biologics Analytical Development

Accountabilities Chromatography Method Development

• Build, optimize, and phase‑appropriately qualify custom (U)
  HPLC methods (SEC, RP, ion exchange, HIC) to monitor critical quality attributes for therapeutic proteins with a focus on fitness for purpose and lifecycle readiness.

• Independently operate, maintain, and troubleshoot UPLC/HPLC systems and detectors (UV, FL, ELSD, CD) to increase reliability, throughput, and data integrity in a cGMP setting.

• Plan and implement method qualification, validation, and transfer to internal and external laboratories; diagnose and resolve performance issues to ensure successful adoption and sustainable performance.

• Perform phase‑appropriate testing to support release and stability, contribute to characterizations and investigations, and translate findings into clear, actionable recommendations.

• Evaluate and implement new instruments, methods, and platforms to improve analytical capability and efficiency; introduce fit‑for‑purpose technologies that improve speed and insight.

• Author SOPs, study plans, protocols, development reports, and draft content that supports regulatory submissions, ensuring clarity, traceability, and compliance.

• Partner with R&D, Manufacturing, QA and QC to align analytical deliverables with program needs, enable process understanding, and support decision‑making across development stages.

• Stay current with evolving scientific principles and regulatory expectations; apply emerging knowledge to solve analytical problems and mentor standard methodologies within the team.

• M.S. degree in Chemistry, Biochemistry, or a related biological science with 3+ years of relevant industry experience (or B.S. degree with 5+ years of experience)
• Hands‑on experience with (U)
  HPLC and practical knowledge of method development and optimization for protein therapeutics
• Ability to take initiative in problem solving and apply an independent, scientific approach to method development and troubleshooting.
• Ability to contribute technical content to regulatory submissions related to analytical sections.
• Hands‑on experience with LC systems from multiple vendors (e.g., Waters, Thermo Fisher), with strong proficiency in chromatography data systems (CDS) such as Empower and Chromeleon.
• Experience developing and optimizing chromatographic methods for protein heterogeneity, aggregation, and degradation pathways.
• Ability to organize and complete work independently with minimal direction.
• Travel may be required on an as‑needed basis to support training and troubleshooting.
• Ability to work in a laboratory environment, including performing tasks with or without accommodation such as lifting/carrying materials, working with biological and hazardous materials, gowning/degowning PPE, and maintaining accurate laboratory documentation.
• Compliance with cGXPs and maintenance of clear, accurate, and complete laboratory records with strong attention to detail

• Ph.D. with 1‑3 years industry experience (particularly in CMC within pharmaceutical or biotech settings)
• Experience with LC‑MS–based protein characterization, including intact mass and peptide mapping using high‑resolution MS platforms (e.g., Orbitrap, Q‑TOF).
• Experience independently generating procedures, protocols, and reports related to analytical test methods.
• Strong working knowledge of current regulatory guidelines (e.g., ICH Q2 and Q14) and cGMP requirements
• Strong analytical thinking skills, including problem solving and data interpretation.
• High emotional intelligence with clear, professional communication skills
• Ability to recognize aberrant test or sample conditions and propose scientifically sound corrective actions.

Join a science‑led, mission‑driven organization where advanced analytics and chromatography translate directly into patient impact. You will work at the intersection of cutting‑edge platforms, rigorous quality standards, and real‑world…