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 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.

**Tech Management Lead (M/F/x) Monoclonal Antibodies**:
**The position**:
**Roles and responsibilities**:

- Lead and coordinate the Site-Launch activities and associated teams for internal and external sites and development projects
- Act as main interface to internal and external sites
- Review technical documentation (protocols, reports) associated with manufacturing, tech transfer, site-to-site transfers and PPQ as needed
- Conduct scouting activities and recommend CDMOs for clinical and launch site selection from Tech Mgmt. Monoclonal Antibodies perspective
- Communicate and implement manufacturing plans at the site which are aligned with crossfunctional CMC strategic discussions
- Communicates outcome of key meetings to stakeholders and functional areas
- Support technical recommendations for future sites and their selections
- Collect and share key data from KPI perspective to improve monoclonal antibody manufacturing site performance
- 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
- Recommend remediations, CAPAs and provide inspection support as appropriate to mitigate risks or gaps
- Participate as in the CMC working group meetings and communicate clear, timely and detailed updates on tech transfers and site activities
- Support the compilation and technical review of relevant CMC sections of regulatory submissions (INDs/IMPDs, NDAs, BLAs, etc.), responses to regulatory questions, briefing books
- Coordinate with lab units, SC, RACMC, QA to drive collaboration and solves issues in Tech Mgmt. Monoclonal Antibodies team

**Personal skills and professional experience**:

- Ph.D. (biochemistry, chemistry, pharmaceutics, engineering, or related disciplines) or master’s degree with equivalent work experience to doctoral degree within pharmaceutical/biotechnology sciences
- Multiple years of experience in the pharmaceutical/biotechnology industry working in a process development environment
- Extensive experience in CMC related functions including biopharmaceutical process (preferably monoclonal antibody manufacturing) and product development
- Strong knowledge of CMC development, process development and technology transfer, CMC regulatory, and GMP compliance in the field of biopharmaceutical products (preferably monoclonal antibodies)
- Strong verbal and written communication skills in English and ability to interface effectively with multi-national teams in a multi-cultural work environment
- Leads global project and cross-functional working teams (e.g. Site Launch Team). Works with the CMC Working Group team to determine the scope, assumptions, and key objectives to enable effective risk management to ensure the timelines are main-tained
- Influences outcomes by negotiating win-win solutions and resolving conflict across the team membership
- Plans and organizes tasks in accordance to the strategic organizational decisions and goals in alignment with overall Technology Development organization
- Contributes to operational planning and organization of a key functional process, continually evaluates priorities of actions and tasks required of the process

**Why work with us?**:

  • Tech Management Lead

    vor 1 Monat

    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 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...

  • Tech Management Lead

    vor 1 Woche

    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...

  • Tech Management Lead

    vor 1 Woche

    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 Management Lead

    vor 1 Monat

    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...

  • Cmc 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...

  • Project Lead

    vor 19 Stunden

    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 Capex Procurement

    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...

  • Lead Buyer

    vor 1 Woche

    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...

  • Lead Buyer Capex

    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...

  • Lead Buyer

    vor 2 Wochen

    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...

  • Lead Buyer

    vor 2 Wochen

    Pfaffenhofen an der Ilm, Pfaffenhofen an der Ilm (Kreis), 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...

  • CMC 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...

  • Technology Transfer Lead

    vor 2 Wochen

    Marburg an der Lahn, Deutschland CSL Behring Vollzeit

    **Position Purpose**: The Technology Transfer Lead role is accountable for planning and successful execution of technology transfer of plasma and recombinant products and intermediates. This leader will be responsible for oversight and management of a cross-functional team of SMEs in a matrix model. This role will have a wide focus requiring an understanding...

  • Lead Buyer Capex, Technical Operations

    Vor 5 Tagen

    Pfaffenhofen an der Ilm, Deutschland Daiichi-Sankyo Europe Vollzeit

    **Passion for Innovation. Compassion for Patients.**: **Lead Buyer Capex, Technical Operations & Facility Management (M/F/x)**: **Purpose of the function**: Questioning the existing, developing completely new approaches and implementing forward-looking concepts. Together with us, you will shape the fascinating development of a successful company with the...

  • Lead Buyer

    vor 3 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...

  • Lead Buyer

    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...

  • Lead Buyer Capex

    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...

  • Team Lead Capex Procurement

    vor 1 Woche

    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...

  • Team Lead Capex Procurement

    vor 4 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...