Project Manager, Technology Transfer

vor 3 Monaten

Aubonne, 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.

A career at our company is an ongoing journey of discovery: our around 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

**Your role**

You will be responsible for the successful Technology Transfer Management of Merck's late stage and commercial biological assets. The position is reporting into the Technology Transfer Director within Global Manufacturing Science and Technology organization for Biologics.

You are accountable for the successful planning and execution of assigned Technology Transfers (Drug Substance/Drug Product/ Combination Products / Finished Products & associate analytics) of Biotech Processes/Products.

Key Responsibilities:

- Manage process transfers on Drug Substance, Drug Product, Combination / Finished Product for commercialized and late stage assets
- Ensure budget preparation as well as oversight and management according to target for assigned responsible TT projects
- Lead Technology Transfers by driving matrixed, cross-functional team (e.g. Supply Chain, Production Unit, Quality Control, Local MSAT, Regulatory, Quality Assurance, HSE, External Manufacturing, cross sites etc.) to ensure successful production campaigns (Eng, validation & commercial campaign)
- Develop projects plans, coordinate project execution, build and improve Tech Transfer project management tools
- Be accountable for success of the product transfer project from initiation to the engineering runs, to process performance qualification until successful transfer completion
- Support the preparation of the regulatory approval - process transfer registration dossier and coordination of other relevant registration documents
- Align with Merck TT local site lead and project team to define project transfer strategy/timeline/activities/FTE/ CAPEX planning and set-up regular follow up meeting.
- Coordinate all the activities with local site TT responsible, provide support to cross functions where required, to ensure/mitigate potential delays, impact to budget etc
- Manage and execute 3rd party/partnered TT projects
- Communicate effectively and proactively to involved departments, site and global leadership and to external partners

**Who you are**
- Degree in Bioprocess Engineering, Biochemistry, Biology, Pharmacy or Pharmaceutical Technology or equivalent scientific degree.
- Expertise in Biologics Drug Substance manufacture and process validation is a must
- MS with minimum 4 years of experience or PhD with minimum 2 years of experience in Drug Substance (Biologics) and/or Drug Product Manufacturing (parenteral) or Bachelor degree with minimum 6 years experience with successful execution of several Drug Substance process transfers
- Relevant and proven experience in Project Management and Technology Transfer is a must
- Fluent in English (writing and speaking), additional languages French or Italian would be a plus
- Excellent Communication skills are essential for this role
- Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion.

**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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