Senior Tech Management Lead

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.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/d) Drug ProductThe 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.AufgabenResponsibilities for the role encompass the following:Lead and coordinate the Site-Launch activities and associated teams for internal and external sites and development projectsStrategically 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 sitesReview technical documentation (protocols, reports) associated with manufacturing, tech transfer, site-to-site transfers and PPQ as neededManage and conduct scouting activities and recommend CDMOs for clinical and launch site selection from Tech Mgmt. Drug Product perspectiveCreate, 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 neededCommunicates outcome of key meetings to stakeholders and functional areas Cross-functionally drive technical recommendations for future sites and their selectionsCollect and share key data from KPI perspective to improve Drug Product site performanceConduct 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 siteRecommend remediations, CAPAs and provide inspection support as appropriate to mitigate risks or gapsParticipate as the Drug Product component lead in the CMC working group meetings and communicate clear, timely and detailed updates on tech transfers and site activitiesSupport the compilation and technical review of relevant CMC sections of regulatory submissions (INDs/IMPDs, NDAs, MAAs, BLAs, etc.), responses to regulatory questions, briefing booksCoordinate 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 stakeholdersProfilPh.D. (biochemistry, chemistry, pharmaceutics, engineering, or related disciplines) or master's degree with equivalent work experience to doctoral degree within pharmaceutical/biotechnology sciencesMultiple years of experience in the pharmaceutical/biotechnology industry working in a drug development environmentExtensive experience in CMC related functions including solid formulation and/or sterile and lyophilized process and product developmentExcellent 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 formulationsCreativity 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 environmentLead 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 maintainedInfluence outcomes by negotiating win-win solutions and resolving conflict across the teamStrong problem solving and risk-based decision-making skills and a demonstrated ability to influence or manage without direct authorityLead one or more programs that have global reach and are highly prioritized within the organizationAbility to develop and implement a long-term vision for Technology Transfer of Drug Product processesIndependently plans and organizes tasks in accordance to strategic organizational decisions and goals in alignment with overall Technology Unit organizationResponsible for operational planning and organization of a key functional process, continually evaluating priorities of actions and tasks required for the processEstablish the objectives and accomplishments required to achieve defined short term or long-term goals, develops, and propose plans to deliver themWir bietenExcellent BenefitsWork-Life BalanceGrowth and DevelopmentHealth and Wellbeing SupportJBTE_DE