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About the Role
Provide technical leadership and subject matter expertise across small molecule drug substance manufacturing, supporting the full product lifecycle from development to commercialization. Collaborate with internal teams and external partners globally.
Responsibilities
- Act as a Subject Matter Expert for small molecule drug substance manufacturing, providing technical leadership.
- Provide technical leadership for external manufacturing products, covering drug substance and drug product manufacture and testing.
- Lead technology transfer and validation activities, including protocol development and delivery.
- Support the transition of products from Phase III clinical development through to commercial launch.
- Partner with Regulatory Affairs on drug substance sections and responses for regulatory submissions.
- Lead technical issue resolution, risk analysis, troubleshooting and continuous improvement with external manufacturing partners.
- Analyze and trend process and analytical data to support technical and regulatory activities.
- Build strong relationships with CMOs and cross-functional stakeholders.
- Lead complex technical projects, balancing multiple priorities while coaching and supporting other team members.
Requirements
- Strong knowledge and hands-on experience in small molecule drug substance manufacturing processes.
- Experience in technology transfer.
- Professional-level English.
- The ability to lead cross-functional teams, manage stakeholders and make independent, risk-based decisions aligned with Ipsen strategy.
- Experience working with or within a CMO/CDMO environment.
- Experience with biological drug substance and/or Antibody-Drug Conjugates (ADCs).
- An understanding of French would be beneficial.
Skills
- Small molecule drug substance manufacturing
- Technology transfer
- Technical leadership
- Subject matter expertise
- Regulatory affairs
- Risk analysis
- Troubleshooting
- Continuous improvement
- Process and analytical data analysis
- Stakeholder management
- Project leadership
Location
- Remote
- Hybrid
Work Type
- Hybrid
Experience Level
- Senior
- Specialist
Education Level
- Degree or higher qualification in natural science, chemistry or a related discipline
- PhD-level qualification in natural science, chemistry or a related discipline
About the Company
- Ipsen is a mid-sized global biopharmaceutical company focused on transformative medicines in 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.
- Tackles areas of high unmet medical need through research and innovation.
- Passionate teams in more than 40 countries focused on what matters and endeavor every day to bring medicines to patients in 88 countries.
- Builds a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact.
- Empowers every individual to be their true selves, grow and thrive alongside the company’s success.
- Journey towards sustainable growth, creating real impact on patients and society.
Equal Opportunity
- Committed to creating a workplace where everyone feels heard, valued, and supported; where we embrace “The Real Us”.
- The value placed on different perspectives and experiences drives commitment to inclusion and equal opportunities.
- When including diverse ways of thinking, more thoughtful decisions are made and more innovative solutions are discovered.
- Strive to better understand the communities we serve.
- Want to help you perform at your best when applying for a role.
- If adjustments or support are required during the application process, let the recruitment team know.
- This information will be handled with care and will not affect the outcome of your application.