Position Summary:
The Biologics Product Development Head, Product Development - Europe will be responsible for growing and leading the product development teams at the three European biologics sites. The scope includes DP formulation and analytical lab support as well as Manufacturing Science & Technology (MS&T) teams supporting manufacturing tech transfer and scale-up. Catalent is also expanding capabilities at our Anagni site for DS and the Head, PD will be responsible for collaborating with the site and Biologics leadership to build that team and capability. The Head is expected to have a comprehensive understanding of biologics development and manufacturing to support solutions for development, early and late stage tech transfers. Collaboration and connection with the full Biologics network including US sites and central team will be an expectation.
The Role:
Collaborate with the VP Biologics, BIO Product Development leadership, site General Managers (GMs), and business leads to drive excellence in product development, to advance technology and feasibility projects to prepare for next generation new products.
The Head, EU PD is expected to lead activities for drug product development, analytical development, drug product process tech transfers and to provide technical support for operation and client visits. Ongoing work by the teams at Anagni and Brussels will be a priority.
The Head will work with the VP PD and the Anagni General Manager to build Drug Substance process development and tech transfer teams and capability in anticipation of readiness for the site expansion.
The Head will work with the VP PD, Limoges GM Business Development and the Director, PD at Limoges to deliver successful early phase DP development and tech transfer.
Manage site Product Development team including performance management, effectively set expectations, drive performance and develop staff.
Execution of projects at the European sites & direct and coordinate activities of scientists and engineers to ensure projects progress on schedule and within budget.
Oversees the alignment and direct technical transfer across departments (PD, manufacturing, Quality) to support new products.
Active participation in client project new proposals for business opportunities from a technical, marketing and pricing perspective & connect with new and existing clients (sites or other visits), act as center of expertise for new development opportunities to BD.
The Candidate:
PhD in Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Science, Biotechnology or related field preferred, with minimum of 8-10 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 minimum of 15 years of relevant experience
Experience in biologics formulations, drug product scale-up and technical transfer with demonstrated knowledge of current industry best practice for sterile product development.
Experience leading biologics formulation and bioanalytical development strategies.
Experience in drug substance development, tech transfer and biologics platforms
Experience developing analytical methods for biologic molecules, familiarity with biologics drug product degradation mechanism as they impact stability.