Location: Catalent Oxford, UK

Position Summary:

The BioModalities Director, Product Development (PD) - Oxford will be responsible for leading the PD team working on RNA and LNP based therapies at our new Oxford, UK site. The Director will be part of a larger PD team which includes process development (upstream/downstream), analytical development, RNA/LNP development, and MS&T. Driving rapid but robust tech transfer of programs will be key. The Director is expected to have a comprehensive understanding of RNA IVT/LNP development and manufacturing to drive solutions for early and late-stage client programs. Collaboration and connection with the full Biologics network including Catalent’s US and European sites will be an opportunity and expectation. Catalent is a rapidly growing, dynamic company and the role offers excellent career opportunities.

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

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.