The Role

:

  • Leading early phase and late phase process/analytical development for RNA/LNP to ensure speed to IND and commercial launch.

  • Leading technical activities for development, process scale-up and tech transfers (internal and external).

  • Recruiting and developing a talented staff, ensuring lab and equipment readiness, and establishment of platform process capabilities.

  • Supporting tech transfer, batch record preparations and resolution of major and critical deviations led by the MS&T team & participating in innovation efforts to evolve Catalent platforms and evaluate new technologies.

  • The Director will manage the RNA LNP process team including conducting performance management for staff, effectively setting expectations, driving execution of project work and developing a talented, diverse and inclusive staff.

  • Interact routinely with Business Development and Commercial operations team & managing budget and assure support to deliver revenue goals.

  • Work with business development, project management and tech leads to review client proposals, drive project completion and lead discussions with clients.

  • Collaborate with the site General Manager (GM) and site leadership colleagues (SLT) to deliver on Catalent business goals.

  • The Candidate:  

  • PhD in Biochemistry, Chemical Engineering, Biotechnology or related field preferred, with 5 plus years of relevant industry experience in biologics development and manufacturing support.

  • M.S./M.A. in Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Science, Biotechnology, or related field, with 10 years of relevant experience.

  • Experience in in RNA/LNP and biologics formulations, drug substance and drug product scale-up and technical transfer with demonstrated knowledge of current industry best practices for biologics.

  • Experience in gene therapy, RNA and related drug substance development, tech transfer and processing platforms

  • Experience and/or working knowledge of developing analytical methods for RNA and LNP molecules, familiarity with biologics drug product formulation and molecule control strategy including regulatory expectations

  • Strong working knowledge of current bioanalytical methods and specifications for RNA LNP and experience/knowledge of QbD in process and product characterization