Title:
Vice President, Biologics Process Development
Company:
Ipsen Biopharm Ltd
About Ipsen:
Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation.
Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!
For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram.
Job Description:
The VP, Biologics Process Development will be responsible for leading the Biologics Process Development (BPD) organization at IPSEN. To deliver the Biologics Process Development (BPD) strategy and operational requirements, as part of the global Pharmaceutical Development (PharmDev) organization. Leading the CMC drug substance process development of all novel Biologics products; including toxins, monoclonal antibodies, antibody drug conjugates, enzymes and other Biologics products developed and in-licensed by IPSEN, from candidature selection to commercialization and life-cycle programs. Managing the teams across Biologics Process and Analytical Development groups, acting as Sponsor for Biologics CMC projects, working effectively with global PharmDev and R&D/TechOps Stakeholders & External partners (CDMOs), to ensure successful global product development and regulatory approvals.
Main Responsibilities & Technical Competencies
- Accountable for defining and delivering a coordinated, comprehensive and strategic CMC process development program for novel toxins, antibodies and other biologics developed/in-licensed by Ipsen across therapeutic areas. Lead the design, development, validation and industrialization of bioprocesses through all stages of development from pre-clinical, clinical to launch and lifecycle; ensuring that robust drug substance processes, analytics, specifications, regulatory documents are delivered for all product development plans; ensuring a science-based approach to ensure effective product - process understanding in line with regulatory requirements; achieve first time regulatory approvals and effective tech transfer to routine manufacture in-house/third party contractors.
- Lead the development groups within BPD; incorporating recruitment, empowerment, operational prioritization and development of managers and staff to ensure the group has the necessary skills, knowledge, motivation and leadership abilities to perform their roles effectively. Manage regular BPD leadership and Department meetings.
- Identify, implement and maintain fit-for-purpose functional technologies, capabilities and staff expertise to support biologics’ pipeline requirements; ensuring personal development, performance, talent management and succession management are integrated and aligned with IPSEN ways of working.
- Build strong collaborative global relationships and proactively engage with key stakeholders across and outside of the business to drive forward and support the Ipsen Biologics strategy.
- Provide proactive membership of the global PharmDev Leadership Team (PDLT), engaging and supporting global PharmDev initiatives, alignment and global practices working closely with the other PDLT members. Lead close collaborative interactions across global PharmDev with DPD (Formulation & Drug Product Development teams), GCSM (Clinical supply management), APID (Small molecule process development), CMC project leadership operations and Quality; supporting leadership of our global interfaces, forums, and project committees in line with ACM.
- Establish and maintain cross-functional interactions aligned with the requirements of IPSEN’s biologics pipeline. Enhance alignments with Research & External Innovation, Early Development and Clinical Development across R&D/therapeutic areas, maintaining close alignments and interfaces with TechOps to define end-end internal/external development, tech transfers and manufacturing requirements.
- Support global Asset Team requirements, CMC project leadership and Due Diligence (Business Development) for evaluation of new Biologics projects as required and the integration of new assets.
- Plan, manage and co-ordinate external partnerships with CDMOs (contract development manufacturing organizations) building our internal/external operation model for CMC development, alongside academic and other industry collaborations. Identify appropriate expert participants and strong collaborative relationships to ensure value and advocacy to internal & external forums to support biologics development.
- Lead continuous improvement activities and ensure best practices are implemented by appropriate benchmarking to improve the efficiency, effectiveness, compliance and customer service. Manage BPD budgets, and capital investment programs (including generation of business cases to support investment), providing short-term and long-term strategic vision of evolution and investments.
- Set and continuously evolve the BPD functional strategy, operating model, capability roadmap and investment priorities in line with the R&D portfolio and PharmDev strategy.
- Provide clear recommendations and make risk informed tradeoffs on portfolio priorities, resources, capacity, externalisation and investment.
- Represent BPD in portfolio and governance discussions, ensuring biologics CMC risks, opportunities and implications are understood and incorporated into enterprise decisions.
- Act as PharmDev/R&D site lead in Wrexham, as a member of the cross-divisional Site Leadership Team, providing input to the development and delivery of site strategy and goals in co-ordination with TechOps on site, promoting cross-functional working, Enterprise Excellence, working to EHS and Quality (cGMP) standards.
Knowledge & Experience
Knowledge & Experience (essential):
- Considerable biologics CMC development expertise, leadership of scientific teams, with experience within the pharmaceutical industry regulatory environment
- Significant leadership experience within global Pharmaceutical Development and CMC organizations, with demonstrated success advancing complex development portfolios from early development to commercialization.
- Expertise across CMC disciplines and relevant scientific knowledge, including DS, DP, Analytical requirements with understanding across Pharmaceutical Development
- Strong regulatory awareness & authoring of regulatory submissions and approvals for relevant Module 3 sections
- Focused, agile and performance driven leadership, experienced budget and staff line management
- Skilled respectful communicator able to lead discussions, influence, managing diverse & multi-cultural teams
Knowledge & Experience (preferred):
- Experience supporting new asset due diligence, integration activities and external partnering initiatives
- Experience implementing matrix-based operating models
- Experience leading organizational transformations
Education / Certifications (essential):
- BSc and PhD level or equivalent experience in relevant scientific discipline.
Language(s) (essential):
We are committed to creating a workplace where everyone feels heard, valued, and supported; where we embrace “The Real Us”. The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunities. When we include diverse ways of thinking, we make more thoughtful decisions and discover more innovative solutions. Together we strive to better understand the communities we serve. This means we also want to help you perform at your best when applying for a role with us. If you require any adjustments or support during the application process, please let the recruitment team know. This information will be handled with care and will not affect the outcome of your application.