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 peptide and protein LC-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 documents for regulatory submissions.
- 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 etc for complex impurity identification/quantitation or low level quantitation.
- Support commercial manufacturing by participating as an analytical expert in investigations troubleshoot 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 new technologies to analytical chemistry labs including advancements in separation technology mass spectrometry techniques data science and data trending.
- Perform routine and non-routine testing of development release and stability samples.
Qualifications :
- 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 instrumentation (e.g. Orbitrap and Q-Tof).
- Proficiency with analytical techniques e.g. HPLC GC 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.
Job level will be commensurate with experience
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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys 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 and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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Work :
No
Employment Type :
Full-time