Scientist l, Biologics Analytical R&D

Job Description

AbbVie Biologics Analytical Research & Development (Biologics Analytical R&D) at Irvine is an analytical sciences organization responsible for early-stage CMC analytical activities related to the development of AbbVie's biologics products. Careers in AbbVie Biologics Analytical R&D provide opportunities to work collaboratively with cross-functional teams to drive scientific understanding and innovative product development strategies. The biologics characterization group develops analytical techniques for in-depth characterization of biologics using separation and compendial techniques.

Responsibilities

• Work with and in areas requiring select agents access (i.e. Biosafety level 2 laboratories) and conduct all work activities in compliance with AbbVie internal and applicable regulatory requirements.
• Adhere to and apply Good Manufacturing Practices (GMP), guidelines and regulations ensuring products are consistently analyzed according to quality standards required in a GMP environment.
• Possess a strong understanding of compendial methodology (USP/EP/JP).
• Perform separation and compendial testing of raw materials, drug substances, and drug products using techniques such as HPLC, Capillary Electrophoresis, Particulate Matter, Osmolality, Karl Fischer, pH.
• Review methods, protocols and SOPs for adherence to GMP principals.
• Participate in cross-functional teams within Biologics Development and provide support and feedback to external departments.
• Openly share scientific expertise and collaboratively help the team to formulate rational solutions to problems.
• Maintain reagent supplies, notebooks, summarize results in written reports and communicate observations to ensure that the end user receives quality methods in a timely manner.
• Comply with Quality Principals related to data generation and reporting.
• Ensure laboratory activities comply with applicable AbbVie safety, quality, data integrity, and regulatory requirements.

Qualifications

• Associate Scientist II: Bachelor Degree with typically 3+ years of experience or Master degree with up to 2 years of experience working in a GxP-regulated environment.
• Scientist I: Bachelor's Degree or equivalent education with typically 5+ years of experience, or Master's Degree or equivalent education with typically 2+ years of experience working in a GxP-regulated environment.
• Understanding in CMC development strategy of biologics drugs is expected.
• Experience and working knowledge in executing separation methods for biologics, including HPLC (RP, SEC, AEX, CEX), gel and capillary electrophoresis (CE, icIEF), as well as compendial techniques, in a cGMP environment.
• Strong communication and presentation skills, with the ability to clearly communicate technical data, conclusions, and recommendations to diverse technical teams.
• Strong organizational skills with the ability to manage multiple priorities.
• Working knowledge of data integrity, laboratory safety, and compliance expectations associated with GxP-regulated analytical testing.