HPLC Specialist, Scientist II, Biologics Drug Product Development

HPLC Subject Matter Expertise

Serve as the department SME for HPLC/UPLC characterization of biologics, demonstrating advanced knowledge of reversed-phase, ion-exchange, size-exclusion, hydrophobic interaction, and other HPLC/UPLC modalities relevant to characterization of biologics.

Lead advanced troubleshooting of HPLC/UPLC instrumentation (e.g., pumps, autosamplers, detectors, columns) and chromatographic methods.

Be accountable and responsible for resolving instrument issues to minimize downtime and work in alignment with team to oversee preventive maintenance schedules and coordinate with instrument vendors and metrology teams to ensure instrument qualification and compliance.

Support company initiatives to increase automation capabilities related to HPLC data collection, storage and overall data integrity; act as an Empower software superuser.

Develop and deliver HPLC training curricula, maintain SOPs and training materials, and serve as a technical resource and scientific consultant on HPLC-related matters.

Formulation & Biologics Drug Product Development

Independently lead and execute drug product process development studies to support clinical studies, including formulation screening, in-use studies, and manufacturing process support.

Generate robust scientific data packages to support IND/NDA/BLA regulatory submissions, CTD module documentation, and technical reports.

Collaborate with cross-functional partners including Analytical Development, Drug substance, Regulatory Affairs, and Quality to advance programs through the development pipeline.

Drive continuous improvement of formulation strategies and drug product processes, applying scientific rigor and innovation.

Scientific Contribution & Communication

Independently analyze, interpret, and document experimental data in electronic lab notebooks (ELN) with clarity and completeness.

Present scientific findings to project teams, management, and cross-functional stakeholders with confidence and scientific rigor.

Contribute to technical reports, regulatory documents, SOPs, scientific publications, and patent applications as needed.

Stay current with emerging trends and innovations in formulation science, analytical chemistry, and HPLC/UPLC technology; proactively apply learnings to internal programs.

Qualifications

• Education:
  • Bachelor's degree in Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering, or a related discipline with typically 4-5 years (Scientist I) or 7+ years (Scientist II) of relevant industry experience
  • Masters degree in a related discipline with typically 2 years (Scientist I) or 5+ years (Scientist II) of relevant industry experience
• Required Experience & Skills:
  • Deep, hands-on expertise with HPLC across multiple modalities (RP-HPLC, SEC, IEC, HIC, etc.) with a proven track record as an SME, including method development and troubleshooting capabilities
  • Demonstrated expertise in formulation development and drug product development for small molecules and/or biologics, including solid oral dosage forms, parenteral, or other delivery systems
  • Proven ability to train and develop others on HPLC instrumentation and analytical methods
  • Proficiency in scientific data analysis and statistical tools, especially chromatography data systems (e.g. Empower)
  • Excellent technical writing skills with experience authoring reports, SOPs, and regulatory documents
  • Ability to independently manage multiple projects with competing priorities