Associate Scientist II - Biologics Drug Product Development
San Francisco, CA, United Statesfull time
On Site
entry
H1B: yes
AbbVie Associate Scientist II at AbbVie supports biologics drug product development through stability studies and analytical assays. The role involves planning and executing formulation stability studies and troubleshooting analytical assays.
Responsibilities
Own & support stability / in-use / process studies: work within the process operations team to fill development drug product batches for GLP toxicology studies, reference standard fills, and representative drug product batches. Develop skills to plan and execute screening, in-use, and formulation stability studies to support formulation and process development for clinical trials.
Perform analytical assays & support troubleshooting: conduct analytical assays to evaluate protein and excipients stability (i.e. HPLC/UPLC, SEC, CEX, CE‐SDS, icIEF, UV-Vis, CD, Karl Fischer titration, HIAC, MFI). Generate high-quality data to support selection of formulation composition, development of dose administration guidance, and drug product manufacturing instructions. Develop the skills to independently troubleshoot assays and instruments to ensure consistent quality data output.
Analyze & communicate results: analyze study results, organize and document the results in an electronic lab notebook (ELN), and effectively communicate updates, troubleshooting, and results to the team. Interpret results and draw conclusions from multistage experiments with support from study owners and project leads. Communicate aberrant data and lab issues to management to gain input and alignment on solution.
Write technical reports and communicate technical updates: Author technical reports to support regulatory filings and present the study results and findings to the team
Collaboration: Collaborate closely with highly matrixed team members to support pipeline programs and participate in project teams as a study owner
Degree in chemistry, chemical engineering, biochemistry, pharmaceutical sciences or equivalent
Bachelor’s degree and typically 3-5 years of experience or master’s degree and typically 0-2 years of experience.
Strong technical background encompassing protein chemistry and protein handling.
Hands-on experience with running and troubleshooting analytical techniques used for protein characterization and stability testing such as SEC, CEX, iCIEF, CE-SDS, HIAC, and MFI.
Ability to work in cross-matrixed team supporting multiple projects and participate in project-focused teams.
Technical ability to execute and troubleshoot experiments through rational and critical thinking. Must be highly organized and detail oriented.
Qualification
Degree in chemistryBachelor’s degree
Required
Degree in chemistry, chemical engineering, biochemistry, pharmaceutical sciences or equivalent
