HPLC Specialist, Scientist II, Biologics Drug Product Development
AbbVie
July 01, 2026
On-site
South San Francisco, CA
$78,500 - $141,000 USD yearly
Clinical Research and Development
HPLC Specialist (Scientist I/II) – Onsite (Lab-based), Bay Area Site, South San Francisco, CA
Key Responsibilities
- Serve as department SME for HPLC/UPLC characterization of biologics; advanced knowledge of RP-HPLC, ion-exchange, size-exclusion, hydrophobic interaction, and other relevant modalities.
- Lead advanced troubleshooting of HPLC/UPLC instrumentation and chromatographic methods.
- Resolve instrument issues to minimize downtime; oversee preventive maintenance; coordinate with instrument vendors and metrology teams for qualification/compliance.
- Increase automation for HPLC data collection/storage and support data integrity; act as an Empower software superuser.
- Develop and deliver HPLC training curricula; maintain SOPs and training materials; serve as technical/scientific consultant.
Formulation & Biologics Drug Product Development
- Independently lead drug product process development studies (formulation screening, in-use studies, manufacturing process support) to support clinical studies.
- Generate IND/NDA/BLA and CTD-related scientific data packages and technical reports.
- Collaborate with cross-functional partners (Analytical Development, Drug Substance, Regulatory Affairs, Quality).
- Drive continuous improvement of formulation strategies and drug product processes.
Scientific Contribution & Communication
- Analyze/interpret/document experimental data in ELN.
- Present findings to teams/stakeholders; contribute to technical/regulatory documents, SOPs, publications, and patents.
- Stay current on formulation science, analytical chemistry, and HPLC/UPLC technology.
Qualifications
- Education: Bachelor’s (Scientist I: 4–5 yrs; Scientist II: 7+ yrs) or Master’s (Scientist I: 2 yrs; Scientist II: 5+ yrs) in a related discipline.
Required Skills/Experience
- Deep, hands-on HPLC expertise across multiple modalities (e.g., RP-HPLC, SEC, IEC, HIC); proven SME in method development/troubleshooting.
- Experience in formulation and drug product development for small molecules and/or biologics.
- Ability to train others on HPLC instrumentation/methods.
- Proficiency in scientific/data analysis and chromatography data systems (e.g., Empower).
- Excellent technical writing skills (reports, SOPs, regulatory documents).
- Ability to manage multiple projects with competing priorities.
Key Responsibilities
- Serve as department SME for HPLC/UPLC characterization of biologics; advanced knowledge of RP-HPLC, ion-exchange, size-exclusion, hydrophobic interaction, and other relevant modalities.
- Lead advanced troubleshooting of HPLC/UPLC instrumentation and chromatographic methods.
- Resolve instrument issues to minimize downtime; oversee preventive maintenance; coordinate with instrument vendors and metrology teams for qualification/compliance.
- Increase automation for HPLC data collection/storage and support data integrity; act as an Empower software superuser.
- Develop and deliver HPLC training curricula; maintain SOPs and training materials; serve as technical/scientific consultant.
Formulation & Biologics Drug Product Development
- Independently lead drug product process development studies (formulation screening, in-use studies, manufacturing process support) to support clinical studies.
- Generate IND/NDA/BLA and CTD-related scientific data packages and technical reports.
- Collaborate with cross-functional partners (Analytical Development, Drug Substance, Regulatory Affairs, Quality).
- Drive continuous improvement of formulation strategies and drug product processes.
Scientific Contribution & Communication
- Analyze/interpret/document experimental data in ELN.
- Present findings to teams/stakeholders; contribute to technical/regulatory documents, SOPs, publications, and patents.
- Stay current on formulation science, analytical chemistry, and HPLC/UPLC technology.
Qualifications
- Education: Bachelor’s (Scientist I: 4–5 yrs; Scientist II: 7+ yrs) or Master’s (Scientist I: 2 yrs; Scientist II: 5+ yrs) in a related discipline.
Required Skills/Experience
- Deep, hands-on HPLC expertise across multiple modalities (e.g., RP-HPLC, SEC, IEC, HIC); proven SME in method development/troubleshooting.
- Experience in formulation and drug product development for small molecules and/or biologics.
- Ability to train others on HPLC instrumentation/methods.
- Proficiency in scientific/data analysis and chromatography data systems (e.g., Empower).
- Excellent technical writing skills (reports, SOPs, regulatory documents).
- Ability to manage multiple projects with competing priorities.