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Title:
MS&T Senior SpecialistCompany:
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:
Are you an expert in oral solid dose drug product formulation and manufacturing processes? Do you have a passion for leading technical projects and building strong relationships with Contract Manufacturing Organisations (CMOs)? If so, we have an exciting opportunity for you!
About the Role:
As an MS&T Senior Specialist, you will be the subject matter expert in oral solid dose drug product formulation and manufacturing processes. You will be accountable for technical and project leadership in the External Manufacturing Organisation (EMO) and will manage technical relationships with CMOs across a global landscape. You will also liaise with R&D, Quality, and Regulatory CMC functions for relevant products.
Key Responsibilities:
Serve as the product owner for small molecule, oral solid dose (OSD) products.
Provide technical leadership for EMO OSD products, including drug substance and drug product manufacture and testing.
Lead validation and technology transfer activities, ensuring successful completion against quality, cost, and timeline.
Manage the activities at internal/external partners to complete successful transfers and provide on-site support as required.
Lead trending and statistical evaluation of data (both process and analytical) and provide data and dossier sections to regulatory submissions.
Optimize QMS in relation to the EMO MS&T team and ensure the supply and management of critical materials and reference standards.
To be considered for this role, you will have:
Degree level (or higher) in natural science, chemistry, or similar (essential).
Experience working with or at a CMO or CDMO (preferred).
Hands-on experience in one or more of the following: small molecule API, biological drug substance, aseptic filling (preferred).
Deep understanding of oral solid dose (OSD) development and manufacturing, formulation development, troubleshooting, and technology transfer (essential).
Proven ability to identify, analyze, and resolve complex technical issues.
Strong project management skills with experience leading cross-functional teams.
Excellent communication and interpersonal skills to work effectively with diverse teams.
Proficiency in English; French is a plus.
Why Join Us?
Opportunity to work with cutting-edge technology in a dynamic and innovative environment.
Collaborative and supportive team culture.
Competitive salary and benefits package.
Career growth and development opportunities.
If you are ready to take your career to the next level and make a significant impact in the field of MS&T, we would love to hear from you!
Apply Now!
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IPSEN is committed to equality of opportunity for all staff and applications, individuals are encouraged to apply regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.