Scientist, Neurotoxin & Biologics Analytical Sciences

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 www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

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What Your New Manager Wants You To Know

The Scientist is responsible for supporting the development, qualification, transfer and validation of cell-based potency assays (bioassay), immunoassay, qPCR, and safety measurement methods for the characterization of proteins and peptides. He/she is responsible for preparing or overseeing the preparation of all documentation associated with automation, as well as ensuring a robust system prior to laboratory implementation. 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 and Method or Operational SOPs. He/She independently carries out multiple analytical methods to support biologics projects depending on departmental needs. Maintains a productive and collaborative laboratory environment consistent with regulatory and company expectations.

You Will
• Execute the development and validation of analytical methods for the characterization of biopharmaceuticals with an emphasis on cell-based potency assays (bioassay), immunoassays, qPCR, and TCID50. 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 Biologics Development and provides support to external departments as time permits. Openly share scientific expertise and collaboratively help the team to formulate rational solutions to problems. Share expertise, instruments and resources within the limitation of established priorities.
• Assist in the identification, development, and implementation of improved workflows in order to optimize laboratory processes for fast turnaround time, cost efficiency, scalability by use of automation system
• Manage outsourced projects from CROs, as needed
• Keep up to date on current and cutting-edge developments in the laboratory analytical technology
• Establish expertise in the operation of instrumentation and applicable laboratory techniques
• 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 production and analytical methods and acquisition of reasonable and 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.

Furthermore, the position requires the individual to work with and in areas requiring select agents and Toxins access (i.e. Biosafety level 2 and biosafety level 3 laboratories). Access to and use of select agents is regulated by federal policies. Therefore, the candidate must conduct all work activities in compliance with Allergan internal and applicable regulatory requirements. Allergan internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.

Qualifications

You Bring

• Experience obtained through a combination of appropriate education (Ph.D.) and 0-4 years of applied experience. Individuals with a MS degree and 5 or more years of applied experience may also qualify. However, individuals with a BS degree and 7 or more years of experience may also qualify.
• Extensive experience with the application of cell culture and bioassay techniques for the characterization of proteins and their degradation and modification products.
• Skill in the use of multiple equipment for the characterization of proteins or peptides (Synergy2, Neo2, MSD Imager, fully automated CSI Imager, Luminex Plate Reader, C. sight, iQue, FlexMap, SMCxPro, Taqman qPCR, ddPCR, and application of liquid handlers in cell-based assay automation and related software for data analysis).
• Skill in the use of handling proteins and experience with standard protein analysis techniques such as Western blotting, SDS-PAGE, ELISA, AAV titering with viral genomic DNA staining and qPCR, AAV viral potency assay (TCID50), preparation of cells for neurotoxin CBPA.
• Experience in cell line development
• The ability to create effective experimental designs.
• Expertise in the operation of instrumentation, automation and applicable laboratory techniques
• Working knowledge of the requirements of working in a GLP or cGMP environments.
• 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.

Job Type
Standard

Schedule
Full-time

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.