Tech Management Lead - Drug Product

Daiichi Sankyo Europe

Pfaffenhofen an der Ilm, Germany

The position:

The Tech Management Lead Drug Product is responsible for 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:

Lead and coordinate the Site-Launch activities and associated teams for internal and external sites and development projects;
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;
Conduct scouting activities and recommend CDMOs for clinical and launch site selection from Tech Mgmt. Drug Product perspective;
Communicate and implement manufacturing plans at the site which are aligned with crossfunctional CMC strategic discussions;
Communicates outcome of key meetings to stakeholders and functional areas;
Support 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 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.

Personal skills and professional experience:

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;
Strong 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;
Strong verbal and written communication skills in English and ability to interface effectively with multinational teams in a multi-cultural work environment;
Leads global project and cross-functional working teams (e.g. Site Launch Team). Works 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;
Influences outcomes by negotiating win-win solutions and resolving conflict across the team;
Plans and organizes tasks in accordance to strategic organizational decisions and goals in alignment with overall Technology Unit organization;
Contributes to operational planning and organization of a key functional process, continually evaluating priorities of actions and tasks required for the process.

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