CMC Lead

Daiichi Sankyo Europe

Pfaffenhofen an der Ilm, Germany

The position:

CMC Lead is responsible for supporting the overall CMC strategies within projects, and manage project teams. These project teams are cross functional teams based on the project needs and the respective development stage of the 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 support successful projects execution with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and escalate the activity status and potential critical issues to the respective governance bodies.

Roles and responsibilities:

Accountability to lead teams within overall CMC development project(s);
Drive strategies and activity within the team to support overall development plan;
Establish good working relationships with internal and external stakeholders;
Leads special project(s)/committee(s) that are critical to Compound development and/or Unit milestones;
Provides leadership in the project/development team as Matrix Lead for cross-functional working teams;
Interfacing with various site locations globally, other functions, and key business partners;
Preparation and presentation of comprehensive internal and external presentations, and decision memo, encompassing all relevant areas of the relevant tasks.

Personal skills and professional experience:

University degree (preferably Ph.D.) in chemistry, biochemistry, pharmaceutics, or related disciplines within pharmaceutical/biotechnology sciences;
At least 4+ years of experience in the pharmaceutical/biotechnology industry working in a drug development environment. Ph.D. (chemistry, biochemistry, pharmaceutics, engineering, or related disciplines) or master's degree with equivalent work experience to doctoral degree within pharmaceutical/biotechnology sciences;
Basic knowledge about GMP requirements within (bio-)pharmaceutical production;
Ability to prioritize and manage multiple activities and priorities simultaneously;
Extensive experience in project management, process, product, and/or analytical development activities and pharmaceutical/oncology project development;
Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA submission experiences for oncology area;
Strong verbal and written communication skills in English;
Ability to interface effectively with multi-national teams in a multi-cultural work environment.

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