Associate Director, CMC Lead

7 days ago

Bernards NJ United States Daiichi Sankyo, Inc. Full time

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

CMC Lead is responsible for supporting the overall CMC strategies within projects, and manage project teams. The project teams will be defined based on the project needs and the respective development stage of the project. The CMC Lead will support the Sr. CMC Lead on complex and/or late-stage project or act as main CMC Lead of an early-stage project. He/she has responsibility for the overall strategy and status of the project with respect to budget, timeline, achievement of defined milestones and overall project risk management. He/she will assess project issues and develop resolutions to meet smooth transition with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status and potential critical issues, or to the governance bodies.

Responsibilities

- Accountability to lead teams within overall CMC development project(s), to support Sr CMC Lead. In case no Sr CMC Lead is established, take main responsibility for CMC lead. Provide operational coordination and management to drive strategies and activities for early and late phase drug development candidates within the team to support overall CMC development plan.
- Represent CMC development project teams on cross-functional drug development project teams with a predominately operational focus; ensuring to establish good working relationships with internal and external stakeholders, e.g., Tech Unit, SMEs. Communicate closely with Sr. CMC Lead, other Tech Unit stake holders, and SMEs to build and execute an effective CMC development strategy.
- Leads special project(s)/committee(s) that are critical to Compound development and/or Tech Unit milestones. Continuously seek opportunities for the improvement in daily work (incl. alternative approaches) and respectively propose/implement such actions. Participate in cross-functional teams responsible for regional and global process improvements in the operational efficiency of PJ Lead and Tech Unit.
- Provides leadership in the project/development team, as Matrix Lead, interfacing with various site locations globally and on Alliance/co-development operational teams, other functions in Technology Unit, and key business partners.
- Requires preparation and presentation of comprehensive internal and external presentations, and decision memo, encompassing all relevant areas of the relevant tasks

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, pharamceutics or related disciplines within the pharmaceutical/biotechnology sciences with at least 7 years of industry experience required
- Master's Degree Master's degree in chemistry, biochemistry, pharmaceutics oe 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 within the pharmaceutical/biotechnology sciences with at least 5 years of industry experience preferred

Experience Qualifications

- 4 or More Years (Preferably) 4 + years of experience with at least 2 + years within CMC Development in the pharmaceutical/biopharmaceutical industry preferred
- 4 or More Years Ability to prioritize and manage multiple activities and priorities simultaneously. preferred
- 4 or More Years Extensive experience in project management, process, product, and/or analytical development activities and pharmaceutical/oncology project development preferred
- 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA submission experiences for oncology area preferred TravelAbility to travel up to 30% Global and domestic travel. International collaboration and communication (face to face, electronic and tele/video conferencing) across all global time 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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