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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 Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Description
Analytical chemist responsible for commercial and pipeline small molecule development within Science and Technology, Pharmaceutical Product Group.
Key Responsibilities Include:
• Lead analytical development, especially in LC-MS, GC-MS and ICP-MS area, to support drug substance and drug product development and manufacturing, including compound structural elucidation, impurity separation, isolation and structural identification, and control strategy development.
• Participate in analytical team activities. Mentor other team members for technical capability development. Provide project proposals and reviews, resource estimation and tracking, and periodical updates to management.
• Independently design experiments, review data and complete results interpretation and reporting. Prepare and review regulatory submission documents.
• Leading the analytical aspects of a project while collaborating with other CMC development functions and other areas in AbbVie to advance drug development.
• Responsible for method development, testing procedures, and implementation of analytical controls to support late-stage analytical development.
• Applying analytical separation and detection modes, such as LC-MS, GC-MS, or ICP-MS for complex impurity identification/quantitation or low level metal quantitation.
• Support commercial manufacturing by participating as an analytical expert in investigations, trouble shoot analytical method issues, and improve method execution.
• Implement a wide range of current analytical techniques to conduct research and development studies related to drug product development.
• Introduce technologies to analytical chemistry labs, such as new separation technology, new techniques in mass spectrometry, data science, and data trending.
• Perform routine and non-routine testing of development, release, and stability samples.
Qualifications
Basic:
• BS or equivalent education and extensive, typically 12+ years of experience; MS or equivalent education with typical 10+ years of experience; PhD with typical 0-4 years of experience in Chemistry or related fields in a pharmaceutical development laboratory setting.
• Advanced degree is preferred.
• Strong background in mass spectrometry and applications in pharmaceutical development is required.
• Strong competency in mass spectrometry data interpretation and structural characterization using MS and tandem MS techniques.
• Experience in developing quantitative analytical methods using mass spectrometry.
• Proficiency with state-of-the-art high-resolution LC-MS and GC-MS instrumentation (e.g., Q-Tof and Orbitrap).
• Proficiency with analytical techniques, e.g., HPLC, GC, ICP, spectroscopic techniques, and physicochemical characterization techniques.
• Candidate must possess solid fundamental training in separation theory.
• Candidate must possess outstanding oral and written communication skills.
• Familiar with ICH and FDA guidance documents in analytical, DS and DP development and manufacturing.
• This position requires an individual who is self-motivated, hard-working, detail-oriented, and able to work in a fast-paced team environment with demonstrated problem solving skills.
• Proven track record in leading analytical projects within a CMC development team setting.
Key Leadership Competencies:
• Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance
• Learns fast, grasps the “essence” and can change course quickly where indicated.
• Raises the bar and is never satisfied with the status quo.
• Creates a learning environment, open to suggestions and experimentation for improvement.
• Embraces the ideas of others, nurtures innovation and manages innovation to reality.
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.
• 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 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.
US & Puerto Rico only – to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
