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Associate Director, Tech Management Lead mAb
4 months ago
Job Description
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 Technology Management (mAb, Drug Substance, Drug Product, or New Modality) Lead is responsible for 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 technology 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
* Lead and coordinate the Site-Launch activities and associated teams for internal and external 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 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 site launch team representative in the CMC working group meetings, as needed, 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.
* Conduct scouting activities and recommend CDMOs for clinical and launch site selection from Tech Mgmt. (mAb, Drug Substance, Drug Product, or New Modality) perspective. Support 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 in the pharmaceutical/biotechnology sciences and at least 7 years of industry experience. required
* Master's Degree Master's degree in chemistry, biochemistry or pharmaceutics or related disciplines in the pharmaceutical/biotechnology sciences with at least 7 years of industry experience preferred
* PhD PhD in chemistry, biochemistry, pharmaceutics or related disciplines in the pharmaceutical/biotechnology sciences with at least 5 years of industry experience.
Experience Qualifications
* 7 or More Years Bachelor's degree in chemistry, biochemistry, pharmaceutics, or related disciplines within pharmaceutical/biotechnology sciences with at least 7 years of industry experience required
* 7 or More Years Master's degree in chemistry, biochemistry, pharmaceutics, or related disciplines within pharmaceutical/biotechnology sciences with at least 7 years of industry experience preferred
* 4 or More Years Ph.D. in chemistry, biochemistry, pharmaceutics, or related disciplines within pharmaceutical/biotechnology sciences with at least 5 years of industry experience preferred
* 4 or More Years Extensive experience in CMC related functions including (mAb, Drug Substance, Drug Product, or New Modality) process and product development preferred
Travel
Ability to travel up to 30%. Global and domestic travel required. International collaboration and communication across all global times zones required.
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.
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