Cmc Lead

vor 6 Monaten

Pfaffenhofen an der Ilm, Deutschland Daiichi Sankyo Europe Vollzeit

**Passion for Innovation. Compassion for Patients.**:
With over 120 years of experience and more than 17,000 employees in over 20 countries, 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 strive to become a global pharma innovator with competitive advantage, creating novel therapies for people with cancer.

Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.

**CMC Lead (M/F/x)**:
**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 de-velopment 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

**Why work with us?**:

  • Regulatory Affairs Cmc Lead

    vor 3 Monaten

    Bad Homburg vor der Höhe, Deutschland Fresenius Kabi Vollzeit

    Focus of the role: Lead and manage CMC regulatory activities related to Biosimilars for development, initial MAA/BLA registration and post approval life cycle management (LCM) worldwide. Define the RA-CMC strategy for the assigned programs and lead execution in close collaboration with internal and external stakeholders Your assignments - As Business...

  • Senior Tech Management Lead

    Vor 7 Tagen

    Pfaffenhofen an der Ilm, Deutschland Daiichi Sankyo Europe Vollzeit

    **Engagiert in der Forschung. Im Einsatz für Patient*innen.**: Mit über 120 Jahren Erfahrung und mehr als 17.000 Mitarbeiter*innen in über 20 Ländern widmet sich Daiichi Sankyo der Entdeckung, Entwicklung und Bereitstellung neuer Behandlungsstandards, die die Lebensqualität weltweit verbessern. In Europa konzentrieren wir uns auf zwei Bereiche: Unser...

  • Tech Management Lead

    vor 2 Monaten

    Pfaffenhofen an der Ilm, Deutschland Daiichi Sankyo Europe Vollzeit

    **Passion for Innovation. Compassion for Patients.**: With over 120 years of experience and more than 17,000 employees in over 20 countries, 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...

  • Tech Management Lead

    vor 6 Monaten

    Pfaffenhofen an der Ilm, Deutschland Daiichi Sankyo Europe Vollzeit

    **Passion for Innovation. Compassion for Patients.**: With over 120 years of experience and more than 17,000 employees in over 20 countries, 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...

  • Tech Management Lead

    vor 6 Monaten

    Pfaffenhofen an der Ilm, Deutschland Daiichi Sankyo Europe Vollzeit

    **Passion for Innovation. Compassion for Patients.**: With over 120 years of experience and more than 17,000 employees in over 20 countries, 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...

  • Tech Management Lead

    vor 1 Monat

    Pfaffenhofen an der Ilm, Deutschland Daiichi Sankyo Europe GmbH Vollzeit

    With over 120 years of experience and more than 17,000 employees in over 20 countries, 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...

  • Tech Management Lead

    vor 2 Monaten

    Pfaffenhofen an der Ilm, Deutschland Daiichi Sankyo Europe GmbH Vollzeit

    With over 120 years of experience and more than 17,000 employees in over 20 countries, 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...

  • Senior Tech Management Lead

    Vor 6 Tagen

    Pfaffenhofen an der Ilm, Deutschland Daiichi Sankyo Europe GmbH Vollzeit

    Mit über 120 Jahren Erfahrung und mehr als 17.000 Mitarbeiter*innen in über 20 Ländern widmet sich Daiichi Sankyo der Entdeckung, Entwicklung und Bereitstellung neuer Behandlungsstandards, die die Lebensqualität weltweit verbessern. In Europa konzentrieren wir uns auf zwei Bereiche: Unser Specialty Business hat es sich zum Ziel gesetzt, Menschen vor...

  • Tech Management Lead

    vor 7 Monaten

    Pfaffenhofen an der Ilm, Deutschland Daiichi Sankyo Europe Vollzeit

    Passion for Innovation. Compassion for Patients. With over 120 years of experience and more than 17,000 employees in over 20 countries, 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...

  • Tech Support Lead

    Vor 5 Tagen

    Pfaffenhofen an der Ilm, Deutschland Daiichi Sankyo Europe GmbH Vollzeit

    With over 120 years of experience and more than 17,000 employees in over 20 countries, 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...

  • Pharmaceutical Industry Expert Team Lead Role

    vor 4 Wochen

    Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

    Daiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative solutions that improve the quality of life for patients worldwide. We are seeking an experienced Pharmaceutical Industry Expert Team Lead to join our team in Munich, Germany.As a Team Lead, you will be responsible for managing a team of...

  • Pharmaceutical Process Lead for Complex Formulations

    Vor 6 Tagen

    Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe GmbH Vollzeit

    ResponsibilitiesDevelop and implement technology transfer strategies for solid and/or parenteral drug productsLead site launch activities and manage timelinesCoordinate input from technical and functional expertsReview technical documentation associated with manufacturing, tech transfer, and site-to-site transfersManage scouting activities and recommend...

  • Team Lead

    vor 2 Wochen

    Pfaffenhofen an der Ilm, Deutschland Daiichi Sankyo Europe Vollzeit

    **Passion for Innovation. Compassion for Patients.**: With over 120 years of experience and more than 17,000 employees in over 20 countries, 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...

  • Team Lead

    vor 6 Monaten

    Pfaffenhofen an der Ilm, Deutschland Daiichi Sankyo Europe Vollzeit

    **Passion for Innovation. Compassion for Patients.**: With over 120 years of experience and more than 17,000 employees in over 20 countries, 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...

  • Senior Biotechnology Project Manager

    vor 2 Wochen

    Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe GmbH Vollzeit

    At Daiichi Sankyo Europe GmbH, we are seeking an experienced professional to fill the role of Tech Management Lead Monoclonal Antibodies.Daiichi Sankyo is a global pharmaceutical company with over 120 years of experience and a presence in over 20 countries. Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and...

  • Senior Tech Management Lead

    Vor 6 Tagen

    Pfaffenhofen an der Ilm, Deutschland Daiichi Sankyo Europe GmbH Vollzeit

    Mit über 120 Jahren Erfahrung und mehr als 17.000 Mitarbeiter*innen in über 20 Ländern widmet sich Daiichi Sankyo der Entdeckung, Entwicklung und Bereitstellung neuer Behandlungsstandards, die die Lebensqualität weltweit verbessern. In Europa konzentrieren wir uns auf zwei Bereiche: Unser Specialty Business hat es sich zum Ziel gesetzt, Menschen vor...

  • Tech Management Lead

    vor 1 Monat

    Pfaffenhofen an der Ilm, Deutschland Daiichi Sankyo Europe GmbH Vollzeit

    With over 120 years of experience and more than 17,000 employees in over 20 countries, 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...

  • Senior Technology Manager

    vor 3 Wochen

    Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe GmbH Vollzeit

    Job DescriptionDaiichi Sankyo Europe GmbH is seeking a highly qualified Senior Technology Manager to join our team.The ideal candidate will have a strong background in CMC development, process development, and technology transfer, with extensive experience in the pharmaceutical industry.Key ResponsibilitiesLead and coordinate site launch activities and...

  • Team Lead

    vor 1 Woche

    Pfaffenhofen an der Ilm, Deutschland Daiichi Sankyo Europe GmbH Vollzeit

    With over 120 years of experience and more than 17,000 employees in over 20 countries, 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...

  • Team Lead

    vor 6 Monaten

    Pfaffenhofen an der Ilm, Deutschland Daiichi Sankyo Europe Vollzeit

    Passion for Innovation. Compassion for Patients. With over 120 years of experience and more than 17,000 employees in over 20 countries, 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...