Vice President, Biologics Process Development

Ipsen Biopharmaceuticals Inc.; Wrexham; On-site; GBP 180,000 - 260,000; Full time

Job summary

Ipsen Biopharm Ltd in the United Kingdom seeks a Vice President, Biologics Process Development to lead the Biologics Process Development organization within PharmDev, steering CMC strategy for novel biologics from candidature through lifecycle. The role drives strategy, regulatory alignment and lifecycle management across global programs.

You will manage Biologics Process and Analytical Development teams, partner with global stakeholders and external partners, and drive regulatory readiness,

Responsibilities

• Define and deliver a coordinated CMC process development strategy.
• Design, develop, validate and industrialize bioprocesses.
• Build cross-functional relationships with internal and external partners.
• Provide leadership to BPD teams and drive staffing and performance.

Job description

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 st