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 www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

The Toxins group within Product development, Science & Technology - Biologics organization supports manufacturing, process validation, regulatory submission, and continuous improvement for late-stage and commercial manufacturing of biological toxins products in AbbVie. We have an exciting opportunity for a Senior Scientist I position based in Irvine, CA. The scientist will apply scientific, analytical principles and statistical process design/analysis to develop, validate and implement robust toxin testing methods. The candidate must have in-depth knowledge and experience including but not limited to analytical method development, qualification, validation and cross-validation with current version of methods where it applies.  Excellent verbal/written communication skills and the ability to work within a multi-disciplinary and cross-functional teamwork environment are essential. 

Responsibilities:

Hands-on experience in cell culture and aseptic techniques, including media preparation, cell culture optimization, cell passaging, and cell banking.Develop and optimize novel cell-based assays ensure successful implementation and routine execution.Support or lead cell-based assay transfer, validation and troubleshooting.Independently design, execute and interpret critical experiments to answer scientific questions. Understand the broad objectives of the project as well as their role in achieving those objectives, and modify experimental plan when required, to respond.Support CMC life cycle management and post-approval continued process validation for commercial DS.Support product investigations and non-conformances. Identify root causes and make scientific recommendations as to the acceptability and quality of affected product lots.Support preparation of relevant CMC sections of submissions and support agency inspections, inquiries and audits.Represent the PDS&T Toxins group in CMC program teams. Interact effectively with diverse groups within function and maintain strong working relationships with internal, global, and external collaborators.Responsible for compliance with applicable Corporate and Divisional policies and procedures
Qualifications
Education: MS in Molecular/ Cellular Biology, Biochemistry or closely related field with typically 8 or more years of experience, BS or equivalent education with typically 10 or more years of industry related experience.Experience in areas of assay development, validation, regulatory submissions, and manufacturing-related investigations.Demonstrated ability to independently design, execute and interpret critical experiments to answer scientific questions.An analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.Excellent communication, writing and presentation skills are required.Must have a “results-oriented” work ethic and a positive “can-do” attitude with a strong sense of urgency and self-motivated desire to achieve.Demonstrated knowledge of GMP and experience providing analytical support in a GMP environmentDemonstrated ability to collaborate effectively in a dynamic, cross-functional matrix environment.Proficient with but limited to the following key technical skills: mammalian cell culture, familiarity with cell culture instrumentation, cell-based assays, qPCR, and ELISA assays.
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 in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay 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/vision insurance and 401(k) to eligible employees.​

This job is eligible to participate in our short-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 benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable 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 AbbVie’s 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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