Scientist l, Biologics Analytical R&D at AbbVie · LumiJobs

Responsibilities

The position requires the individual to work with and in areas requiring select agents access (i.e. Biosafety level 2 laboratories). Access to and use of select agents is regulated by federal policies. Therefore, the candidate must conduct all work activities in compliance with AbbVie internal and applicable regulatory requirements. AbbVie internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.
Strong understanding, knowledge and ability to 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.
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.

Scientist l, Biologics Analytical R&D

Responsibilities

Qualification

Required

Benefits

Company

AbbVie

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