Senior Tech Management Lead

Vor 2 Tagen

Pfaffenhofen an der Ilm, Deutschland Daiichi Sankyo Europe GmbH Vollzeit

Mit über 120 Jahren Erfahrung und mehr als 17.000 Mitarbeiter*innen in über 20 Ländern widmet sich Daiichi Sankyo der Entdeckung, Entwicklung und Bereitstellung neuer Behandlungsstandards, die die Lebensqualität weltweit verbessern.

In Europa konzentrieren wir uns auf zwei Bereiche: Unser Specialty Business hat es sich zum Ziel gesetzt, Menschen vor Herz-Kreislauf-Erkrankungen, der führenden Todesursache in Europa, zu schützen. Außerdem möchten wir betroffenen Patient*innen helfen, jeden kostbaren Moment des Lebens zu genießen. In der Onkologie streben wir danach, ein weltweit führender Pharma-Innovator mit Wettbewerbsvorteilen zu sein und neue Therapien für Menschen mit Krebs zu entwickeln.

Unser europäischer Hauptsitz befindet sich in München, Deutschland, und wir haben Niederlassungen in 13 europäischen Ländern und Kanada.

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.


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

  • Ph.D. (biochemistry, chemistry, pharmaceutics, engineering, or related disciplines) or master's degree with equivalent work experience to doctoral degree within pharmaceutical/biotechnology sciences
  • Multiple years of experience in the pharmaceutical/biotechnology industry working in a drug development environment
  • Extensive experience in CMC related functions including solid formulation and/or sterile and lyophilized process and product development
  • Excellent knowledge of CMC development, process development and technology transfer, CMC regulatory, and GMP compliance in the field of small molecule solids and/or biologics parenteral formulations
  • Creativity and demonstrated track record of success in drug development, tech transfer and validation.
  • Strong verbal and written communication skills in English and ability to interface effectively with multi-national teams in a multi-cultural work environment
  • Lead global project and cross-functional working teams (e.g. Site Launch Team, Component Team). Work with the CMC Working Group team to determine the scope, assumptions, and key objectives to enable effective risk management to ensure the timelines are maintained
  • Influence outcomes by negotiating win-win solutions and resolving conflict across the team
  • Strong problem solving and risk-based decision-making skills and a demonstrated ability to influence or manage without direct authority
  • Lead one or more programs that have global reach and are highly prioritized within the organization
  • Ability to develop and implement a long-term vision for Technology Transfer of Drug Product processes
  • Independently plans and organizes tasks in accordance to strategic organizational decisions and goals in alignment with overall Technology Unit organization
  • Responsible for operational planning and organization of a key functional process, continually evaluating priorities of actions and tasks required for the process
  • Establish the objectives and accomplishments required to achieve defined short term or long-term goals, develops, and propose plans to deliver them

  • Attraktive Benefits
  • Work-Life-Balance
  • Persönliches Wachstum und Entwicklung
  • Gesundheit und Wohlbefinden

CRWL1_DE

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