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About the Role
The Drug Product Development group is responsible for developing and characterizing drug product formulations and manufacturing processes for biologic therapeutics. This role is for an HPLC Specialist (Scientist I/II) to join our team at our Bay Area site in South San Francisco, CA. This is an onsite, lab-based role requiring daily face-to-face cross-functional interactions.
Responsibilities
- 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.
- Lead advanced troubleshooting of HPLC/UPLC instrumentation and chromatographic methods.
- Resolve instrument issues to minimize downtime and oversee preventive maintenance schedules.
- 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.
- Serve as a technical resource and scientific consultant on HPLC-related matters.
- Independently lead and execute drug product process development studies to support clinical studies.
- 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.
- Drive continuous improvement of formulation strategies and drug product processes.
- Independently analyze, interpret, and document experimental data in electronic lab notebooks (ELN).
- Present scientific findings to project teams, management, and cross-functional stakeholders.
- Contribute to technical reports, regulatory documents, SOPs, scientific publications, and patent applications.
- Stay current with emerging trends and innovations in formulation science, analytical chemistry, and HPLC/UPLC technology.
Requirements
- 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.
Skills
- HPLC/UPLC characterization of biologics
- Reversed-phase HPLC
- Ion-exchange HPLC
- Size-exclusion HPLC
- Hydrophobic interaction HPLC
- HPLC/UPLC instrumentation troubleshooting
- Empower software
- Formulation development
- Drug product process development
- Scientific data analysis
- Statistical tools
- Technical writing
- Project management
Location
- South San Francisco, CA
Work Type
- Onsite
- Lab-based
Experience Level
- Scientist I/II
- 4-5 years (Scientist I) or 7+ years (Scientist II) of relevant industry experience with Bachelor's degree
- 2 years (Scientist I) or 5+ years (Scientist II) of relevant industry experience with Master's degree
Education Level
- Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering, or a related discipline
- Master’s degree in a related discipline
Salary/Compensations
- USD 78500 - USD 141000 - yearly
Benefits
- Paid time off (vacation, holidays, sick)
- Medical/dental/vision insurance
- 401(k)
- Short-term incentive programs
About the Company
- AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.
- We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio.
Equal Opportunity
- AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.
- Equal Opportunity Employer/Veterans/Disabled.
- US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
- US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html