Senior Scientist, I

1 week ago

East Irvine, 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 atwww.abbvie.com. Follow @abbvie onTwitter,Facebook,Instagram,YouTubeandLinkedIn.
Job Description

The PDS&T Toxins group within Operations Science & Technology - Biologics organization supports manufacturing, process validation, regulatory submission, and continuous improvement for late-stage and commercial manufacturing of biological toxin products at AbbVie. We have an exciting opportunity for a Senior Separations Scientist position based in Irvine, CA.

  • Lead the development, qualification, validation and troubleshooting of separation methods for biologics including HPLC, capillary electrophoresis and SDS-PAGE.
  • Provide analytical support for process characterization and manufacturing of late-stage and commercial biological programs.
  • Identify and drive continuous improvement initiatives and implement new technologies to contribute to future business developments and improvements.
  • Author CMC analytical sections of BLA and other CMC regulatory packages, including analytical methods, specifications, analytical comparability, and stability assessment. Support agency inspections and inquiries.
  • Present analytical development topics in cross-functional CMC meetings.
  • Partner with diverse groups within the function and maintain strong working relationships with internal, global, and external collaborators.
  • Perform routine testing of in-process samples using various separation techniques.
  • Troubleshoot any issues that arise during routine testing and provide solutions to ensure accurate and reliable results.
  • Perform method validations in a GMP laboratory setting to ensure compliance with regulatory requirements. Author protocols, reports, and SOPs for development and GMP laboratories.
    Qualifications
    • Bachelor's, Master's, or Ph.D. degree in Biochemistry, Analytical Chemistry, Pharmaceutical Sciences, Biophysics, or a closely related field.
    • Minimum of 8 years of industry-related experience with a Bachelor's degree, 6 years with a Master's degree, or 0+ years required with a Ph.D.
    • Proven track record in successfully developing HPLC based methods for biologic products.
    • Experience with analytical method transfer and validation to support late-phase and commercial processes is a plus.
    • Excellent interpersonal and oral/written communication skills.
    • Results-oriented work ethic and a positive "can-do" attitude with a strong sense of urgency and self-motivated desire to achieve common business goals.
    • Demonstrated ability to collaborate effectively in a dynamic, cross-functional matrix environment.


      Additional Information

      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 postingbased 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 orless 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.

        Note: No amount of payis a considered to bewages 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 paidandmay be modified at the Companys sole and absolute discretion, consistent with applicable law.

        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.

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