Product analyst Jobs in Schweitenkirchen

Passion for Innovation. Compassion for Patients.

With over 120 years of experience and approximately 19,000 employees in more than 30 countries / regions, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.

In Europe, we focus on two areas : The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life.

In Oncology, we are driving innovation in solid tumours and blood cancers, founded on breakthrough science from our own labs in Japan. We aspire to create better tomorrows for people living with cancer and their loved ones.

Our European headquarters are in Munich, Germany, and we have affiliates in 15 European countries and Canada.

For our development and production site in Pfaffenhofen / Ilm we are seeking highly qualified candidates to fill the position :

Senior Tech Management Lead (m / f / x) Drug Product

The position :

The Senior Tech Management Lead Drug Product is responsible for the development of the strategy and the management of technology transfer of the manufacturing processes of solid and / or parenteral Drug Products for investigational and commercial drugs to the sites of manufacture, both internal and external to Daiichi Sankyo, until transition to routine manufacture. The candidate is leading the Site Launch Team with its associated sub-teams. Accordingly, the candidate is responsible for executing the technology transfer in accordance with the established standard processes to facilitate alignment of tech transfer and validation activities across the projects for Drug Product manufacturing, evaluates CMC risks for appropriate escalation, recommends transition milestones and ensures a smooth transition of projects, recommends, and implements new technologies, as needed and supports Supply Chain Management with technical issues during routine commercial production.

Roles and responsibilities :

Responsibilities for the role encompass the following :

• Lead and coordinate the Site-Launch activities and associated teams for internal and external sites and development projects
• Strategically drive as Component Lead for programs with complex supply chains having multiple manufacturing sites and secure global alignment among the different sites. Act as main interface to internal and external sites
• Review technical documentation (protocols, reports) associated with manufacturing, tech transfer, site-to-site transfers and PPQ as needed
• Manage and conduct scouting activities and recommend CDMOs for clinical and launch site selection from Tech Mgmt. Drug Product perspective
• Create, communicate and implement technology transfer and manufacturing plans at the site which are aligned with crossfunctional CMC strategic discussions. Manage timelines, deliverables, and coordinate the input of technical and functional experts as needed
• Communicates outcome of key meetings to stakeholders and functional areas Cross-functionally drive technical recommendations for future sites and their selections
• Collect and share key data from KPI perspective to improve Drug Product site performance
• Conduct data review and analysis, data-driven decision-making process and support data transfer to the appropriate data repository - liaison between data digitalization team and the site
• Recommend remediations, CAPAs and provide inspection support as appropriate to mitigate risks or gaps
• Participate as the Drug Product component lead in the CMC working group meetings and communicate clear, timely and detailed updates on tech transfers and site activities
• Support the compilation and technical review of relevant CMC sections of regulatory submissions (INDs / IMPDs, NDAs, MAAs, BLAs, etc.), responses to regulatory questions, briefing books
• Coordinate with lab units, SC, RACMC, QA to drive collaboration and solve issues in Tech Mgmt. Drug Product team Interface with various site locations globally, other functions in the Technology Unit and key business partners. Establish and maintain good working relationships with internal and external stakeholders

Personal skills and professional experience :

Why work with us?

Working at Daiichi Sankyo is more than just a job – it is your chance to make a difference and change patients’ lives for the better. We can only achieve this ambitious goal together. That is why we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the opportunity to grow, think boldly, and contribute your ideas. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.