Scientist l, Biologics Analytical R&D
About The Position
AbbVie Biologics Analytical Research & Development in Irvine is an analytical sciences organization responsible for early-stage CMC analytical activities supporting development of AbbVie biologics products. The biologics characterization group develops analytical techniques for in-depth characterization using separation and compendial methods. This role works collaboratively with cross-functional teams to support scientific understanding and innovative product development strategies. The position performs analytical testing of biologics raw materials, drug substances, and drug products, and requires work in Biosafety Level 2 laboratories requiring select-agent access. The employee must comply with applicable federal regulations and AbbVie requirements for ethics, environmental health and safety, financial, human resources, quality, data integrity, and general business practices. The role also supports method and documentation review, laboratory operations, and communication of scientific findings.
Requirements
- Bachelor’s degree or equivalent education with typically 5+ years of experience, or a master’s degree or equivalent education with typically 2+ years of experience working in a GxP-regulated environment.
- Understanding of CMC development strategy for biologics drugs.
- Experience and working knowledge executing separation methods for biologics, including HPLC (RP, SEC, AEX, CEX), gel electrophoresis, and capillary electrophoresis (CE, icIEF), as well as compendial techniques in a cGMP environment.
- Strong communication and presentation skills, including the ability to clearly communicate technical data, conclusions, and recommendations to diverse technical teams.
- Strong organizational skills and ability to manage multiple priorities.
- Working knowledge of data integrity, laboratory safety, and compliance expectations associated with GxP-regulated analytical testing.
Responsibilities
- Perform separation and compendial testing of raw materials, drug substances, and drug products using techniques including HPLC, capillary electrophoresis, particulate matter testing, osmolality, Karl Fischer, and pH.
- Apply Good Manufacturing Practices, guidelines, and regulations to ensure products are analyzed consistently according to quality standards in a GMP environment.
- Review methods, protocols, and SOPs for adherence to GMP principles.
- Participate in cross-functional teams within Biologics Development and provide support and feedback to external departments.
- Share scientific expertise and collaborate with the team to formulate rational solutions to problems.
- Maintain reagent supplies and laboratory notebooks, summarize results in written reports, and communicate observations to deliver quality methods in a timely manner.
- Comply with quality principles related to data generation and reporting.
- Ensure laboratory activities comply with applicable AbbVie safety, quality, data integrity, and regulatory requirements, including requirements related to select-agent access.
Benefits
- Paid time off, including vacation, holidays, and sick leave.
- Medical, dental, and vision insurance for eligible employees.
- 401(k) for eligible employees.
- Eligibility to participate in short-term incentive programs.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
