Scientist I, Analytical Chemistry

Envision working with energetic colleagues and inspirational leaders. Now, place yourself in that mix; leading discussions, asking the right questions and driving results.

What Your New Manager Wants You To Know
 

The Scientist is responsible for supporting the development, qualification, transfer and validation of analytical methods for the analysis and characterization of neurotoxin and biologics entities with experience required in the following,

• Separation techniques including HPLC (RP, SEC, HIC, IEX), gel and capillary electrophoresis (SDS-PAGE, native-PAGE, CE, cIEF)

Compendial techniques

Knowledge in cGMP regulations and hands-on cGMP experience are desired.

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 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.

YOU ARE more than just a title, YOU ARE…

A strategic thinker: align and excite internal stakeholders to facilitate success through strong leadership, strategic thinking and personal drive.

First class team player: collaborate across multiple disciplines to ensure compliance and ability to influence cross-functional teams and senior leadership.

You Will

• 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.
• Keep up-to-date on current and cutting-edge developments in the biologics characterization field.
• 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.

You Bring
 

• Experience obtained through a combination of appropriate education. Individuals with a MS degree and 2+ years of applied experience may also qualify.  Individuals with a BS degree and 5+ years of experience may also qualify.
• Extensive experience with the application of separation, compendial, and biophysical techniques for the characterization of proteins and their degradation and modification products.
• Understanding in CMC development strategy of biologics drugs is expected.
• A solid understanding of methods and procedures related to the production and characterization of biopharmaceuticals in a regulated environment is expected.
• A strong analytical and instrument skills and a thorough understanding and working knowledge of analytical method development and validation.
• Working knowledge of the requirements of working in a cGMP environment is desired.

AbbVie is an equal opportunity employer including disability/vets. 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 disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.