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