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Principal Research Scientist I

4 months ago

Irvine, Kentucky, United States AbbVie Full time

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

The Principal Research 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.

Key Responsibilities

Lead development of phase appropriate separation methods to support toxin development programs at various phases by managing direct reports

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.

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 AbbVies 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
BS or equivalent education and extensive, typically 14+ years of experience; MS or equivalent education with typically 12+ years of experience; PhD with typically 6+ years of experience in area or scientific area of discipline.Advanced knowledge and experience in developing, validating and transferring separation methods for biologics, including HPLC (RP, SEC, HIC, IEX), gel and capillary electrophoresis (SDS-PAGE, native-PAGE, CE, cIEF)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.Extensive working knowledge of the requirements of working in a cGMP/GSP environment is desired.Prior experience of supervising staffs is highly desiredThorough understanding in CMC development strategy of biologics drugs is expected. Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes ingood faith it will pay for this role at the time of this posting based on the job grade for this position. Individualcompensation paid within this range will depend on many factors including geographic location, and we may ultimatelypay 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/visioninsurance and 401(k) to eligible employees.This job is eligible to participate in our short-term incentive programs.This job is eligible to participate in our long-term 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 benefitsthat are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent with applicable law.
Additional Information
AbbVie 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.