Senior Scientist, Neurotoxin & Biologics Analytical Sciences

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Job description

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . on Twitter , Facebook , Instagram , YouTube and LinkedIn .

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 Senior Scientist is responsible for the analysis and characterization of neurotoxin and biologics entities to support the development, qualification, transfer and validation of analytical methods including:

• Separation techniques including HPLC (RP, SEC, HIC, IEX), gel and capillary electrophoresis (SDS-PAGE, native-PAGE, CE, cIEF)
• Characterization techniques such as mass spectrometry and biophysical-based characterization methods (UV, fluorescence, light scattering, subvisible particle analysis, CD, AUC, DSC, ITC)
• Immunoassay, cell-based bioassay, and qPCR

CMC development experience is expected since this position will be participating or leading the analytical strategy setup as part of the CMC strategy for Abbvie's biologics development projects. Knowledge in cGMP regulations and hands-on cGMP experience are desired.
He/She will provide scientific leadership as an expert across the R&D and operation functional groups and in different project teams for the analytical characterization of biological drugs. 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 or operational SOPs, and relevant sections in regulatory filing. 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. Mentor staff within a matrix environment when 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 the department 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.
• Make staffing recommendations related to direct reports and communicates desired forward path to mid-and-senior level management for endorsement/implementation. Evaluates performance for direct reports and assists with staff development via recommendations for internal and external technical training and scientific conferences. Consistently treats direct reports and other team members and all Abbvie employees with respect.

Qualifications
You Bring

• Experience obtained through a combination of appropriate education (Ph.D.) in biological or related field and 4+ years of relevant analytical pharma/biotech industry experience. Individuals with a MS degree and 7+ years of applied experience may also qualify.
• Extensive experience with the application of separation, and mass spectrometric, and biophysical techniques for the characterization of proteins and their degradation and modification products. Cell culture, molecular biology, immunoassay and bioassay techniques are also required.
• 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

In this role, we're looking for a leader who will:
Act as an Owner
Be Excellence Focused
Act as an Influencer
We Will Give You 'The Abbvie Edge'

At AbbVie we define an 'edge' as something that sets us apart, gives us an advantage and strengthens us to be better - for our customers, patients, investors and each other. Our 'edge' is our colleagues, and we are committed to making Allergan the best place for them to work and achieve career goals.

How do we do this? We Engage, Develop, and Reward our colleagues.
Engage. From Day 1, you are a bold leader who wants to make an impact. We listen to your ideas and questions, so we can be even better at what we do.
Develop. Learn every day, build new skills every day. We prioritize development, so our leaders are always ready for the next challenge and opportunity.
Reward. Exceptional performance creates exceptional opportunities and rewards. Financial awards and incentives are just a part of this - we invest in our people; celebrate success through recognition programs; and promote healthy lifestyles and work-life balance.

• Key Leadership Competencies:
• Builds strong relationships with peers and cross functionally with partners outside of the immediate team to enable higher performance
• Learns fast, grasps the "essence" and can change course quickly where indicated
• Raises the bar and is never satisfied with the status quo
• Creates a learning environment, open to suggestions and experiments to drive the science in the field of interest
• Embraces the ideas of others, nurtures innovation and manages innovation to reality

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 10 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.