Associate Director, tLNP Formulation

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 www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

We are seeking a leader responsible for the oversight of formulation development, sterile fill-finish process development, scale-up, tech transfer and manufacture of targeted lipid nanoparticles (tLNPs) for pre-clinical and clinical studies.  The successful candidate should demonstrate his/her ability in establishing and leading a growing formulation team and will work seamlessly with external manufacturing organizations to complete GMP testing. In addition, the incumbent will be expected to establish systems in the department to enable manufacturing of the batches for non-clinical safety studies and clinical studies under GMP. The candidate will oversee work on a cross-functional product development team including liaising with Biologics CMC, Synthetic Molecule CMC, Clinical Operations, Regulatory Affairs including addressing requests for Health Authorities, and Quality Assurance in development and commercialization of drug products.  

Responsibilities:

• Responsible for overseeing formulation development of targeted lipid nanoparticles (tLNPs) entering FIH, as well as formulation optimization and commercial formulation definition prior to pivotal clinical trials. 
• Responsible for evaluation of novel product presentations for tLNPs, which may include a lyophile, spray dried powder, nonaqueous suspension, or other advanced presentations, and the process development thereof. 
• Designs, oversees, and reviews clinical in-use studies to evaluate the stability and compatibility of tLNP drug products. 
• Manages contract development and manufacturing organizations (CDMOs) involved in sterile fill finish operations of tLNPs. 
• Reviews and approves documents related to formulatio