Scientist l, Biologics Analytical R&D Full-time

AbbVie Biologics Analytical Research & Development

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. We are looking for candidates with strong scientific experience to join the AbbVie Analytical R&D team and can offer exciting career opportunities for these candidates.

Responsibilities

• 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.

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.

Additional Information

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html

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Pay Range:

$ 75000 – 142500 USD