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Job Description
Senior Scientist I, tLNP Formulation
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 atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.
Job Description
About the Team
The Targeted Lipid Nanoparticle (tLNP) drug product developmentgroupwithin AbbViestLNPCMCteamis committed to advancing clinical-stagetLNPassets from First-in-Human (FIH) through Phase 2. The team collaborates across biologics discovery, CMC partners, Clinical Operations, Regulatory Affairs, Quality Assurance, and external manufacturing to support development and commercialization oftLNPproducts. Key focus areas include establishing robust formulation and process development capabilities, leading critical CMC activities for pipeline programs, devising formulation development strategies, conducting stability evaluations, optimizing clinical in-use strategies, developing innovative product presentations, implementing stage-based quality risk management, and driving scientific initiatives to ensure the strong development of current and futuretLNPprograms.
Purpose
We are seeking a SeniorScientist Ito lead key scientific initiatives and provide leadership in the development of early stage targeted Lipid Nanoparticle (tLNP) assets within AbbVies pipeline. This roleis responsible fordesigning, executing, and effectively communicating hypothesis-driven formulation and process development activities. The successful candidate will collaborate closely with analytical teams, process development groups, and subject matter experts across AbbVie to advance research and development in thetLNPspace.
Responsibilities
AssesstLNPliabilities under practical worst-case stress conditions to inform excipientselectionand formulation screening strategies
Design and execute comprehensive formulation screening studies, evaluating variables such as pH, buffer, antioxidants, surfactants, cryoprotectants, and other stabilizing excipients
Lead process development, optimization, and robustness studies, with a focus on sterile fill-finish operations
Facilitate scale-up, technology transfer, and manufacturing readiness in close collaboration with internal and external stakeholders
Utilize statistical methods and Design of Experiments (DoE) to optimize formulations and process parameters
Develop and communicate clinical in-use strategies for investigational products, including assessment of in-use stability for clinical-stage programs
Plan and conduct experiments to evaluate innovativetLNPproduct presentations, such as lyophilized forms, spray-dried powders, nonaqueous suspensions, and other advanced formats
Interpret and present critical data, key findings, and recommendations in both internal and cross-functional team forums
Maintain high laboratory productivity while ensuring strict adherence to corporate safety, quality, andgood research practices
Practice robust documentation standards by accurately recording experimental data, results, and conclusions in electronic lab notebooks, technical reports, and scientific presentations
Qualifications
Required
PhD in Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering, Biotechnology, or a related field (0+ years industry experience); or MS with 6+ years of relevant industry experience
Comprehensive theoretical knowledge of ICH regulations governing drug product formulation and sterile process development
Proven experience in formulation, process development, and analytical characterization of protein therapeutics
Experience characterizing thermal (glass transition, recrystallization)andphysico-chemical(pH shifts)events taking place at sub-zero temperatures (typically -20C to -80C)in frozen drug product solutions
Proficient in formulation characterization methods such as Dynamic Light Scattering (DLS), Differential Scanning Calorimetry (DSC), and chromatographic techniques (RP-HPLC, SEC, IEX)
Demonstrated ability to independently design, execute, and troubleshoot complex formulation experiments
Skilled at analyzing and interpreting multidisciplinary datasets to enable scientific decision-making
Exceptional written and verbal scientific communication skills
Preferred
Hands-on experienceinmRNA, lipid nanoparticles (LNP), targeted LNP systems, or biologics drug product development
Demonstratedexpertisein biologics manufacturing processes, including sterile fill-finish operations, lyophilization, and spray drying
Strong familiarity with LNP and protein formulation characterization techniques such as mRNA encapsulation efficiency assays and antibody binding assays (qELISA)
Proficient inutilizingstatistical software and Design of Experiments (DoE) methodologies for process and formulation optimization.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:
The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeofthis posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location,andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
This job is eligible to participate in our short-term incentiveprograms.
Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of anybonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's soleandabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable 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.
