Executive Director, Biologics Development
Our client is a fast growing highly profitable multinational biopharmaceutical company with a large exciting pipeline of drug compounds at an advanced stage in research. This newly created role, will lead their Biologics development team.
This leadership position will lead the Biologics development team responsible for progression of the portfolio of biologics projects at various stages of the development life cycle from early development through commercialization and life cycle management.
It will have responsibility for drug substance, formulation and drug product and bioanalytical development activities. Activities may be performed internally or with external partners.
The role will involve significant cross functional collaboration with other functions in R&D in addition to Technical Operations (manufacturing, quality & supply chain), working towards agile new product introduction and ensuring all processes are understood, robust, efficient and in control.
- Technical, scientific and strategic leadership and oversight of technical development for biologics development programs
- Manage resources, budgets, contracts and external relationships necessary to the effective functioning of the group
- Provide leadership, support and team-members to high-performing cross-functional Biologics CMC Development teams while ensuring successful outcomes
- Application of CMC regulatory requirements for pharmaceutical products and in particular the evolving opportunities offered by application of QbD principles and ICH guidelines
- Develop and maintain close collaboration with R&D functions including but not limited to non-clinical, clinical, regulatory, medical and project management.
- Work closely with all leaders to monitor and where necessary, implement improvement initiatives in line with continuous improvement philosophy
- Serve as a member of the Technical Development leadership team, participating in portfolio review and project governance meetings and providing guidance for best practices and direction for continuous improvement
- Participate in due diligence assessments of new business development opportunities, as required
- Ensure that all processes are in line with health, safety, environmental and quality requirements including regulations, policies, applicable guidelines and procedures
- Continue to develop knowledge and remain abreast of new pharmaceutical development and manufacturing technologies as required, in line with company business strategy & objectives
- Over fifteen years of experience required with a broad experience across biologics development (drug substance and product) and manufacturing technologies and functions with exposure to multiple drug delivery technologies and platforms.
- Broad and demonstrated expertise in the phase appropriate development of diverse biologics modalities and dosage forms with associated formulation and process technologies
- Proven track record of leadership through approval and commercialization of multiple Biologics Drug/Combination products.
- Demonstrated technical proficiency, scientific creativity, collaboration with others and independent thought in suggesting experimental designs to support process development objectives
- Significant experience managing and working with contract development and manufacturing organisations
- Excellent managerial, leadership, communication and collaborative skills. Must possess a keen awareness and understanding of people-management and team dynamics.
- Demonstrated track record of training and coaching colleagues to improve overall team process knowledge & effectiveness.
- Proven project management skills for technical programs
- Thorough and detailed knowledge of current regulatory expectations and demonstrated experience of successful licensures with FDA, EMA and other agencies.
- Track record of success in cross functional collaboration
- Bachelor’s degree with a masters or PhD in science or engineering