Associate Scientist II - Biologics Drug Product Development
AbbVie
Summary
The Biologics Drug Product Development group within AbbVie is a global organization responsible for developing and characterizing drug product formulations and manufacturing processes for biologic therapeutics (antibodies, antibody-drug conjugates (ADCs), neurotoxins, and novel biologic formats) from preclinical development through clinical proof of concept. This is a lab-based position and requires fulltime on-site presence.
Job description
Key Responsibilities
- Own & support stability / in-use / process studies: fill development drug product batches for GLP toxicology studies, reference standard fills, and representative drug product batches.
- Plan and execute screening, in-use, and formulation stability studies to support formulation and process development for clinical trials.
- Perform analytical assays to evaluate protein and excipients stability (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.
- Independently troubleshoot assays and instruments to ensure consistent quality data output.
- Analyze study results, document in an electronic lab notebook (ELN), and communicate updates, troubleshooting, and results to the team.
- Interpret results and draw conclusions from multistage experiments with support from study owners and project leads.
- Author technical reports to support regulatory filings and present study results and findings to the team.
- Collaborate closely with highly matrixed team members to support pipeline programs and participate in project teams as a study owner.
Qualifications
- 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.
- Eagerness to learn and apply new scientific techniques.
- Excellent verbal and written communication skills.
- Strong collaborative skills for working effectively within the team.
- Prior experience in protein formulation development, process development, drug delivery, or analytical functions is highly preferred.
- Prior experience utilizing automated liquid handlers and/or executing high-throughput screening workflows is highly preferred.
Requirements
- 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
- Eagerness to learn and apply new scientific techniques
- Excellent verbal and written communication skills
- Strong collaborative skills for working effectively within the team
- Prior experience in protein formulation development, process development, drug delivery, or analytical functions is highly preferred
- Prior experience utilizing automated liquid handlers and/or executing high-throughput screening workflows is highly preferred
Benefits
- Paid time off
- Holidays
- Sick leave
- Medical, Dental & Vision
- 401(k)
- Short-term incentive programs
Company overview
AbbVie is a global biopharmaceutical company that discovers, develops, and markets advanced therapies for some of the world's most complex and serious diseases. Founded in 2013 as a spin-off from Abbott Laboratories, AbbVie has established itself as a leader in immunology, oncology, neuroscience, eye care, and virology. The company's flagship product, Humira (adalimumab), was one of the world's top-selling drugs for treating autoimmune conditions like rheumatoid arthritis and Crohn's disease. AbbVie maintains a robust pipeline of innovative medicines and has expanded its portfolio through strategic acquisitions, including Allergan in 2020. With research facilities across the United States and globally, AbbVie focuses on advancing science to improve patient outcomes while maintaining strong commercial operations worldwide. The company operates with a patient-centric approach and invests significantly in research and development to address unmet medical needs across multiple therapeutic areas.