Tech Management Lead Drug Substance

Tech Management Lead Drug Substance

Daiichi Sankyo Europe

Pfaffenhofen an der Ilm, Germany

The position:

The Tech Management Lead Drug Substance is responsible for the management of technology transfer of the manufacturing processes of drug substance (especially Antibody-Drug Conjugates) for investigational and commercial drugs to the sites of manufacture, both inter-nal and external to Daiichi Sankyo, until transition to routine manufacture.

The candidate is leading the Site Launch Team with its associated subteams. Accordingly, the candidate is responsible for executing the technology transfer in accordance with the established stand-ard processes to facilitate alignment of tech transfer and validation activities across the pro-jects for drug substance manufacturing, evaluates CMC risks for appropriate escalation, rec-ommends 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 Substance 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 substance manufacturing site performance;
• Conduct data review and analysis, data-driven decision-making process and support data transfer to the appropriate data repository - liaison between the Tech Strategy (data digitalization) 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, BLAs, etc.), responses to regulatory questions, briefing books;
• Coordinate with lab units, SC, RACMC, QA to drive collaboration and solves issues in Tech Mgmt. Drug Substance 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;
• At least many years of experience in the pharmaceutical/biotechnology industry working in a process development environment;
• Extensive experience in CMC related functions including biopharmaceutical process (preferably drug substance manufacturing) and product development;
• Strong knowledge of CMC development, process development and technology trans-fer, CMC regulatory, and GMP compliance in the field of biopharmaceutical products (preferably drug substance);
• Strong verbal and written communication skills in English and ability to interface effectively with multi-national 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 membership;
• Plans and organizes tasks in accordance to the strategic organizational decisions and goals in alignment with overall Technology Development organization;
• Contributes to operational planning and organization of a key functional process, continually evaluates priorities of actions and tasks required of the process.

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