Scientist I / II, Liquid Chromatography (LC), tLNP Analytical R&D

Company Description

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The Analytical Development group within the Targeted LNP (tLNP) CMC Team at AbbVie is dedicated to advancing state-of-the-art analytical capabilities for mRNA-lipid nanoparticle therapeutics. Our team provides critical support across drug substance (DS) and drug product (DP) manufacturing, drug product formulation, and the development and implementation of robust analytical methodologies to ensure the quality, safety and integrity of tLNP genetic medicines. We leverage advanced biophysical, separations, and mass spectrometry techniques to deeply characterize intact LNP particles. We foster close collaborations with cross-functional colleagues in CMC, drug product formulation, and external partners, and are currently growing a world-class team of scientists who will be instrumental in building and deploying the analytical toolbox necessary to deliver high-quality, innovative tLNP medicines to patients.

Position Description: 

As a Liquid Chromatography (LC) Scientist within the Analytical Development team of AbbVie’s Targeted LNP (tLNP) CMC organization, you will support the development, optimization, qualification, transfer, and lifecycle management of LC-based analytical methods supporting tLNP programs.

The role will focus on LC methods used to evaluate the different modalities and components that comprise tLNP products, including monoclonal antibodies (mAbs), lipids, Linearized DNA (LDNA), mRNA, and LNP/tLNP. The successful candidate will have strong hands-on experience developing and troubleshooting chromatographic methods, such as ion-pair reversed-phase (IPRP), reversed-phase LC (RPLC), ion-exchange chromatography (IEX), size-exclusion chromatography (SEC), and other relevant LC techniques. The primary mission of this role is to independently develop and troubleshoot robust LC methods supporting analytical characterization, release, stability, and comparability assessment of tLNP components and products.

This individual is expected to maintain a strong laboratory presence while providing technical leadership in chromatographic method development and problem solving. The candidate will also collaborate across the global Analytical CMC organization and with R&D and CMC partners, including Discovery, Preclinical Safety, Process Chemistry, Process Engineering, Drug Product Development, Quality Assurance, and CMC Regulatory Affairs.

Responsibilities:

• Serve as an LC focused Scientist, design, develop, optimize, and execute LC-based methods supporting release, stability, characterization, comparability, and in-process testing.
• Develop and optimize chromatographic methods for multiple tLNP-related modalities, including lipids, mAbs, LDNA, mRNA, and LNP/tLNP. Experience in one or more relevant modalities is expected; the successful candidate will expand their expertise in these related modalities through collaboration and training.
• Apply a strong understanding of chromatographic separation principles to method development, including investigation of critical method parameters, selectivity, resolution, peak shape, recovery, and overall method performance.
• Lead root-cause investigations into chromatographic performance, sample preparation, instrumentation, column chemistry and method robustness.
• Maintain a strong laboratory presence and demonstrate a high level of scientific initiative, creativity, independence, and productivity.
• Develop robust analytical methods by systematically evaluating key method variables and applying Design of Experiments (DOE) approaches when appropriate.
• Lead or support method qualification, transfer, implementation, and lifecycle management of LC-based analytical methods.
• Provide technical guidance and troubleshooting support for LC testing performed internally and at external CDMOs and contract testing laboratories.
• Analyze and interpret experimental data, identify trends, draw scientifically sound conclusions, and clearly communicate findings and recommendations.
• Collaborate effectively with analytical, process development, formulation, quality, regulatory, and other cross-functional partners.
• Contribute to continuous improvement of analytical capabilities by evaluating and implementing new chromatographic technologies and approaches.
• Prepare and review technical reports, methods, protocols, presentations, and other analytical documentation.
• Ensure laboratory activities comply with applicable AbbVie safety, quality, data integrity, and regulatory requirements. 

Qualifications

• Bachelor’s or Master’s degree in Analytical Chemistry, Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline, typically with:
  • Scientist I: Bachelor’s with 5+ years of relevant industry experience, or Master’s with 2+ years of relevant industry experience.
  • Scientist II: Bachelor’s with 7+ years of relevant industry experience, or Master’s with 5+ years of relevant industry experience.
  • Leveling will be commensurate to experience level. 
• Strong understanding of chromatographic separation principles and demonstrated hands-on experience in LC method development.
• Direct experience with multiple LC separation techniques, such as RPLC, IPRP, SEC, IEX/IEC, and/or HIC.
• Demonstrated ability to independently develop, optimize, and troubleshoot LC methods, rather than solely execute established methods.
• Demonstrated ability to perform routine instrument maintenance and basic instrument troubleshooting.
• Hands-on experience with LC instrumentation from Agilent, Thermo Fisher Scientific, and/or Waters.
• Hands-on experience with Empower chromatography data software.
• Demonstrated understanding of the impact of key chromatographic variables on method performance and experience using systematic method-development approaches, including DOE where appropriate.
• Direct experience developing, optimizing, qualifying, and/or transferring LC-based methods for at least one relevant modality, such as lipids, LDNA/oligonucleotides, mRNA, antibodies/proteins, or LNPs.
• Ability to independently investigate and troubleshoot chromatographic, sample-related, and instrument-related issues.
• Ability to provide technical oversight and troubleshooting support for analytical work conducted at CDMOs or contract testing laboratories.
• Working knowledge of data integrity, laboratory safety, and compliance expectations associated with GxP-regulated analytical testing.
• Strong scientific communication and presentation skills, with the ability to clearly communicate technical data, conclusions, and recommendations to both technical and non-technical stakeholders.

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 roleat  the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on manyfactors  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 isearned,  vested,  and determinable. The amount and availability of  any bonus, commission, incentive, benefits, or any other form of compensation and benefits that areallocable 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 absolutediscretion,  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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