AbbVie Scientist II, Bioassay Automation in Irvine, California
Envision working with energetic colleagues and inspirational leaders. Now, place yourself in that mix; leading discussions, asking the right questions, and driving results.
The Scientist is responsible for implementing automated solutions such as liquid handlers and other automation devices to increase efficiency and throughput for bioassays (cell-based assays and immunoassays). The scientist is responsible for maintaining the devices in an operable state and training others on how to use them. The Scientist is also responsible for supporting the development, qualification, transfer, and validation of analytical methods for the analysis and characterization of neurotoxin and biologics entities.
He/She collaborates with scientific staffs to plan experimental work and executes protocols in support of biologics process development, formulation development, and stability studies. The individual independently generates, compiles, and evaluates data for technical reports to support regulatory filings for new and currently marketed biological products. The individual is also responsible for writing sections or subsections of technical reports, method and/or operational SOPs. He/She independently carries out multiple analytical methods to support AbbVie biologics projects depending on departmental needs. Maintains a productive and collaborative laboratory environment consistent with regulatory and company expectations.
The position requires the individual to work with and in areas requiring select agents and toxins 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.
Support development of phase appropriate separation methods to support toxin development programs
Execute the development and validation of analytical methods for the analysis and characterization of biopharmaceuticals. Create written procedures and protocols. Transfer, qualify or validate methods as needed.
Apply routine and specialized analytical techniques to characterize and quantify biopharmaceuticals. Maintain reagent supplies, notebooks, summarizes results in written reports and communicates observations to ensure that the end user receives quality methods in a timely manner. Comply with Quality Principals related to data generation and reporting.
Actively participate on cross-functional teams within Biologics Development and provide support to external departments. Openly share scientific expertise and collaboratively help the team to formulate rational solutions to problems.
Develop protocols and SOPs, train staff and maintain the laboratory consistent with departmental and company requirements. Understand, document, and adjust Quality Systems to match the project stage (e.g. pre-development or development).
Maintain a good and current knowledge of the scientific and technical literature pertinent to the project and necessary for development of state-of-the-art analytical methods, including the acquisition of necessary equipment.
Make high quality scientific presentations at internal management, regional and national meetings to help advance AbbVie’s image as the thought and product leader in the neuromodulator field. Present and defends product, assay and process data to regulatory agencies.
Bachelor’s Degree or equivalent education with typically seven years of experience, or Master’s Degree or equivalent education with typically 5+ years of experience.
Experience with liquid handler systems (e.g. Hamilton, HighRes BioSolutions, Opentrons) and software
Experience in the area of designing and qualifying in vitro cell-based assays to reflect the relevant molecular mode of action.
Experience in cell culture and state-of-the-art cell and molecular biology techniques.
Knowledge and experience in developing, validating, and transferring separation methods for biologics, including qELISA (quantitative), Cell-Based Potency Assays (CBPA), enzyme activity assays and other bioassays.
Understanding of methods and procedures related to the production and characterization of biopharmaceuticals in a regulated environment is expected.
General understanding in CMC development strategy of biologics drugs is expected.
Experience in working in a GMP environment – Compliance, documentation practices, and quality mindset.
Critical Reagent Management/ Procurement – Experience with inventory management, procurement, and maintenance of quality documents (e.g. CofAs)
Understanding of how neurotoxin structure relates to biological function is a plus.
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
· 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.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
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