Job Location : Atlanta,GA, USA
Join a Legacy of Innovation 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology, Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
Summary
The Senior Technology Management (mAb, Drug Substance, Drug Product, or New Modality) Lead is responsible for the development of the strategy and the management of technology transfer of the manufacturing processes of (mAb, Drug Substance, Drug Product, or New Modality) for investigational and commercial drugs to the sites of manufacture, both internal and external to Daiichi Sankyo, until completion of the first CPV. 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 (mAb, Drug Substance, Drug Product, or New Modality) 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 post first CPV.Responsibilities- Strategically drive as Component Lead for programs with complex supply chains having multiple manufacturing sites and secure global alignment among the different sites. Lead and coordinate the Site-Launch activities and associated teams for multiple internal and external manufacturing sites and development projects. Serve as the main interface to internal and external manufacturing sites. Review technical documentation (protocols, reports) associated with manufacturing, technology transfer, site-to-site technology transfers and PPQ as needed. 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.- Create, communicate, and implement technology transfer and manufacturing plans at the site which are aligned with cross-functional CMC strategic discussions. Manage timelines, deliverables, and coordinate the input of technical and functional experts as needed. Participate as the (mAb, Drug Substance, Drug Product, or New Modality) component lead in the CMC working group meetings and communicate clear, timely and detailed updates on tech transfers and site activities. Recommend remediations, CAPAs and provide inspection support as appropriate to mitigate risks or gaps at the manufacturing sites.- Manage and conduct scouting activities and recommend CDMOs for clinical and launch site selection from Tech Mgmt. (mAb, Drug Substance, Drug Product, or New Modality) perspective. Cross-functionally drive technical recommendations for future manufacturing sites and their selections. Collect and share key data from KPI perspective for CDMOs to improve (mAb, Drug Substance, Drug Product, or New Modality) manufacturing site performance.- Communicate outcomes of key meetings to stakeholders and functional areas (i.e., stage gates, working group meetings – upstream, downstream, analytical, shipping logistics). 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. Coordinate with lab units, SC, RACMC, QA to drive collaboration and solves issues in Tech Mgmt. (mAb, Drug Substance, Drug Product, or New Modality) team.- Support the compilation and technical review of relevant CMC sections of regulatory submissions (INDs/IMPDs, NDAs, BLAs, etc.), responses to regulatory questions, briefing books.
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications (from an accredited college or university)- Bachelor's Degree Bachelor's degree in chemistry, biochemistry, pharmaceutics or related disciplines within the pharmaceutical/biotechnology sciences with at least 12 years of industry experience required- Master's Degree Master's degree in chemistry, biochemistry, pharmaceutics or related disciplines in the pharmaceutical/biotechnology sciences with at least 9 years of industry experience. preferred- PhD in chemistry, biochemistry, pharmaceutics or related disciplines in the pharmaceutical/biotechnology sciences with at least 7 years of industry experience preferred
Experience Qualifications- 7+ years of professional experience in chemistry (at PhD level), biochemistry, pharmaceutics, or related disciplines within pharmaceutical/biotechnology sciences with at least 7 years of industry experience preferred- 7+ years of professional experience (at MS level) in chemistry, biochemistry, pharmaceutics, or related disciplines within pharmaceutical/biotechnology sciences with at least 9 years of industry experience preferred- 7 + years of professional experience (at BS level) in chemistry, biochemistry, pharmaceutics, or related disciplines within pharmaceutical/biotechnology sciences with at least 12 years of industry experience required- Must have demonstrated knowledge of CMC related functions including (mAb, Drug Substance, Drug Product, or New Modality) process and product development preferred- Must have demonstrated expertise and knowledge of CMC development, process development and technology transfer, CMC regulatory, and GMP compliance in the field of (mAb, Drug Substance, Drug Product, or New Modality) or similar formats preferred
Travel
Ability to travel 10-20%. Domestic and international travel. International collaboration and communication across all global time zones
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.