Drug Product Lead

vor 19 Stunden

CorsiersurVevey, Schweiz Merck KGaA Darmstadt Germany Vollzeit

Work Your Magic with us

Ready to explore, break barriers, and discover more? We know you've got big plans - so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

**Your role**:
In your role as Drug Product Lead, you will ensure successful management of activities in the Drug Product development area and actively report the status (progresses, delays, risks, issues, mitigations, budget) of the relevant CMC programs.

Further, your role will be to develop a Drug product development plan, establish a development budget, and define and monitor project milestones, in line with the overall CMC development strategy. Be the key driver of the technical excellence of the DP activities. Advocate for the Quality by Design approaches and seek for optimization and value proposition opportunities in the CMC programs.

Be the main interface among the Drug Product development Function, the CMC team, the CMC Lead, and all relevant stakeholders; assure smooth communication among the parties so that all the project-related information is appropriately communicated and aligned. You will lead the multi-site Drug Product development sub-teams, and manage the DP supply of different development phases. Ensure that the documentation of the relevant program is thorough, completed on time, and meets the quality requirement. Overall the role requires ensuring compliance with regulatory and health authorities' guidelines and a high level of performance level on all Excellent Foundations levers (EHS, People, Quality, Service and reliability, Efficiency, and Cost).

**Who you are:
- Master's degree in Chemistry, Biology, or Biochemistry or Engineering degree in Life Science / Biochemistry / Biology / Chemical discipline
- Demonstrated track record (at least 7 years) in Biopharmaceutical / Biotechnology industry or equivalent in the field of formulation, process, or analytical development for new biological entities (NBEs)
- Scientific expertise in Biotech Drug Product development, especially in high potency product, freeze drying format, and QbD approaches
- Knowledge related to the CMC dossier and CDMO management are strongly preferred
- Proven experience in Program Management of moderate to high complexity (at least, 3 years in program management; PMO or any other certification in Project management will be considered as an advantage)
- Proficiency in English, oral and written. German, French, or Italian is a plus

**What we offer**:We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress

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