Senior Scientist I, tLNP Formulation

About the Team 

The Targeted Lipid Nanoparticle (tLNP) drug product development group within AbbVies tLNP CMC team is committed to advancing clinical-stage tLNP assets 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 of tLNP products. 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 future tLNP programs. 

Purpose 

We are seeking a Senior Scientist I to lead key scientific initiatives and provide leadership in the development of early stage targeted Lipid Nanoparticle (tLNP) assets within AbbVies pipeline. This role is responsible for designing 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 the tLNP space.  

Responsibilities 

• Assess tLNP liabilities under practical worst-case stress conditions to inform excipient selection and 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 innovative tLNP product 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 and good 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) and physico-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 experience in mRNA lipid nanoparticles (LNP) targeted LNP systems or biologics drug product development 
• Demonstrated expertise in 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 in utilizing statistical 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 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 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