Senior Scientist I
1 month ago
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us Follow @abbvie onTwitter,Facebook,Instagram,YouTubeandLinkedIn.
Job Description
Envision working with energetic colleagues and inspirational leaders. Now, place yourself in that mix; leading discussions, asking the right questions, and driving results.
Our department develops analytical methods for the analysis and characterization of neurotoxin biologics in CMC development. 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.
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.
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 organization-wide 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 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 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 and typically 10 years of experience, Masters Degree or equivalent education and typically 8 years of experience, PhD and no experience necessary.Strong experience in the area of designing and qualifying in vitro cell-based assays to reflect the relevant molecular mode of action.Strong experience in cell culture and state-of-the-art cell and molecular biology techniques.Understanding of how neurotoxin structure relates to biological function is a plus.Advanced 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.A strong analytical and instrument skills and a thorough understanding and working knowledge of analytical method development and validation.A solid understanding of methods and procedures related to the production and characterization of biopharmaceuticals in a regulated environment is expected.Understanding in CMC development strategy of biologics drugs is expected.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law: The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees. This job is eligible to participate in our short-term incentiveprograms. This job is eligible to participate in our long-term incentiveprograms Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies 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. US & Puerto Rico only - to learn more, visit
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