Scientist II, Analytical Development

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 II is 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.

He/She independently plans 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 individual must follow all SOPs (Standard Operating Procedures) GMP (Good Manufacturing Practices) and methods while maintaining proper documentation.

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.

• 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 in a GMP enviroment.
• 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.
• Represent department for important organizationwide initiatives to support establishment of infrastructures.
• 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 crossfunctional 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. predevelopment or development).
• Maintain a good and current knowledge of the scientific and technical literature pertinent to the project and necessary for development of stateoftheart analytical methods including the acquisition of necessary equipment.
• Make high quality scientific presentations at internal management regional and national meetings to help advance AbbVies image as the thought and product leader in the neuromodulator field. Present and defends product assay and process data to regulatory agencies.

Qualifications :

• Bachelors Degree or equivalent education with typically 7 years of experience or Masters Degree or equivalent education with typically 5 years of experience.
• Experience and working knowledge in developing and validating separation methods for biologics including HPLC (RP SEC) gel and capillary electrophoresis (CE icIEF) as well as compendial techniques in a cGMP environment.
• Strong understanding of methods and procedures related to GMP and compendial methodology.
• General understanding in CMC development strategy of biologics drugs is expected.
• PhD candidates need not apply. 

Additional Information :

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 

• This is an onsite opportunity at AbbVies Irvine CA location. 
• 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 shortterm 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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law. 

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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