Director, Synthetic Molecules Analytical R&D

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 X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok .

Job Description

Description:

The Analytical Research & Development team is seeking a talented, highly motivated candidate that is a recognized industry expert in areas of structural elucidation, impurity management including nitrosamine and mutagenic impurities, physical analytical characterization and methodology for enhanced stability modeling. The successful candidate will be responsible for leading a team in the design, development, and implementation of technology for the characterization of drug substance and drug products of synthetic molecules and peptides. We are looking for diverse candidates with a strong scientific and leadership experience to join the AbbVie Analytical R&D team and can offer exciting and rewarding career opportunities for these candidates. The ideal candidate will have CMC expertise in analytical development for both synthetic and biomolecule therapeutics. The candidate will be responsible for assisting with the development and execution of analytical methods to support CMC and will participate in phase-appropriate characterization of material and products at all stages of the development process, as well as monitoring completion of tasks and projects. This role will provide scientific leadership, strategic direction, and cross-functional collaboration to ensure robust analytical control strategies aligned with regulatory expectations.

Responsibilities:

• Lead development and implementation of advanced analytical characterization for drug substance and drug product methods to support a range of modalities including small synthetic molecules and complex peptide development programs.
• Utilize cutting-edge structure elucidation techniques (e.g., high-resolution, tandem mass spectrometry, nuclear magnetic resonance) to characterize a wide range of modalities across AbbVie’s pipeline.
• Lead cross-functional teams and collaborate with multi-disciplinary experts to develop strategies to enable the structure elucidation aspects of a project to advance programs through the development pipeline including impurity management to develop control strategies for mutagenic and nitrosamine impurities.
• Advance scientific expertise beyond ARD organization. Proactively advise and share knowledge and expert opinions with subordinates, peers, and senior management. Mentor and train colleagues and assesses current and emerging business challenges enabling functional goal achievement.
• Ensure quality and effectiveness of key results of major project plans through sound design, early risk assessments, and implementation of fallback strategies.
• Source and identify emerging scientific trends in the field of molecular characterization of therapeutics from internal and external sources and assess relevance. Integrate trends into functional short-term objectives. Advance cross discipline technology and direction within area of discipline.
• Apply imagination and innovation by creating, inventing, and implementing new or better approaches, alternatives and breakthrough ideas across disciplines.
• Make significant contributions to project team and deliver results in a team-oriented setting and will work across scientific disciplines to drive programs through critical milestones.
• Generate new scientific proposals and lead those efforts. Anticipate and critically evaluate scientific or regulatory advances and respond with appropriate new strategies.
• Drives innovation and technical excellence for a multi-functional organization
• Drive scientific rigor, operational excellence, and consistent execution as a key contributor to overall CMC and portfolio strategy.

Qualifications

• PhD (with 12+ years’ experience) in scientific discipline (e.g., Analytical Chemistry, Biochemistry, Chemical Biology or related field) with previous pharmaceutical laboratory experience.
• Deep understanding of pharmaceutical develop applications utilizing mass spectrometry, nuclear magnetic resonance spectroscopy, impurity management and control strategy development, physical analytical characterization (DSC, TGA, XRPD, FTIR, Raman, particle size and morphology analysis, microscopy), and biophysical techniques (e.g. optical spectroscopy, structure, and binding).
• Practical experience and strong knowledge of LC separations (e.g., HPLC, GC, IP-RP LC, SEC), capillary electrophoresis, and other separation techniques as applied to small molecules and peptide/oligonucleotide analysis.
• Experiences with the project and people leadership in the development of pharmaceutical development.
• Strong technical background with proven ability to innovate with a history of new or improved product release and publications.
• High-quality written and oral communication skills and ability to interact effectively with interdisciplinary scientists and engineers.

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 and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

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