Manager (m/w/d) Formulation Technology – Biologics

Daiichi Sankyo Europe GmbH; Pfaffenhofen an der Ilm; On-site; EUR 70,000 - 110,000; Full time

Benefits offered by this job

Excellent Benefits

Work-Life Balance

Growth and Development

Health and Wellbeing Support

Job summary

Daiichi Sankyo Europe GmbH sucht eine Führungskraft im Bereich Formulation Technology – Biologics. Sie planen, organisieren und unterstützen Entwicklungsaktivitäten im Bereich Parenteral Formulation und Prozessentwicklung, einschließlich DoE und CMO-Management in Europa, sowie die Erstellung regulatorischer Unterlagen.

Sie arbeiten eng mit internationalen Teams zusammen, betreuen Transferprojekte zu internen Standorten und CMOs, und tragen zur Optimierung von Herstellungsprozessen bei, um

Qualifications

• Universitätsabschluss in Pharmazie oder verwandtem Fachgebiet, idealerweise mit Ph.D. in pharmazeutischer Technologie.
• Mindestens zwei Jahre relevante Berufserfahrung in der pharmazeutischen Industrie (Formulierung und Prozessentwicklung).
• Erfahrung im CMO-Management, globale CMC-Entwicklung, Technologie-Transfer.
• Erfahrung mit Design of Experiments und Hochskalierung GMP‑kompatibler Prozesse.
• CMC-regulatorische Anforderungen und Einreichungen.
• Sehr gute schriftliche und mündliche Kommunikationsfähigkeiten in Englisch und Deutsch.
• Gute IT-Kenntnisse (MS Office, SAP etc.).
• Reisebereitschaft.

Responsibilities

• Entwicklung, Optimierung und Hochskalierung GMP‑kompatibler Lyophilisierungsprozesse für Biologics.
• Erstellung von Risikoanalysen und DoE im Rahmen von Formulierungs- und Prozessentwicklung.
• Zusammenarbeit mit einem jungen Entwicklungsteam zur Erweiterung analytischer Fähigkeiten.
• Fach- und technische Leitung von CMOs für klinische Studienmaterialherstellung und Transfers.
• Unterstützung beim Erstellen und Prüfen von Herstellungsprotokollen und Berichten.
• Unterstützung bei regulatorischen Einreichungsdokumenten (NDA/BLA).
• Zusammenarbeit mit internationalen Projektteams (Japan, USA, CMOs in Europa).

Skills

Kommunikationsfähigkeiten (Englisch/De

Teamfähigkeit

Reisebereitschaft

Education

Universitätsabschluss in Pharmazie oder verwandtem Fachgebiet, idealerweise mit PhD in pharmazeutischer Technologie

Tools

MS Office

SAP

Job description

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.

Manager (m/w/d) Formulation Technology - Biologics

Purpose of the function

The "Manager Formulation Technology - Biologics" is responsible for the planning, organization and technical support of development activities in Formulation Technology for Parenteral Formulation and Process Development (e.g. lyophilization) incl. physicochemical characterization of Biologics (focus on oncology, e.g. ADCs). The functional and technical management of contract manufacturing organizations (CMO Management) for manufacturing parenteral dosage forms in Europe and supporting the preparation of regulatory submissions (e.g., NDA, BLA, and post-approval changes) are also within the scope of this position.

• Development, optimization and upscaling of GMP-compatible manufacturing processes for lyophilization of biologics (e.g. Anti-body drug conjugates, ADCs), incl. preparation and documentation of development activities
• Creation of risk analyses and statistical design of experiments (DoE) within the framework of formulation and process development of biologics
• Co-working with a young development team for developing and extending the department analytical capabilities with focus on physicochemical characterization of Biologics, as well as the occupational health and safety concepts for handling of high potent compounds
• Functional and technical management of contract manufacturing organizations (CMOs) for clinical trials material manufacturing, as well as technology transfers to in-house manufacturing sites and CMOs in Europe, incl. on-site support
• Supporting the team in creating and reviewing manufacturing protocols and reports
• Support the preparation of regulatory submission documents; incl. NDA, and BLA.
• Collaboration with various international multidisciplinary project teams (incl. colleagues from Japan, US and CMOs in Europe)

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.

Manager (m/w/d) Formulation Technology - Biologics

Purpose of the function

The "Manager Formulation Technology - Biologics" is responsible for the planning, organization and technical support of development activities in Formulation Technology for Parenteral Formulation and Process Development (e.g. lyophilization) incl. physicochemical characterization of Biologics (focus on oncology, e.g. ADCs). The functional and technical management of contract manufacturing organizations (CMO Management) for manufacturing parenteral dosage forms in Europe and supporting the preparation of regulatory submissions (e.g., NDA, BLA, and post-approval changes) are also within the scope of this position.

Aufgaben

• Development, optimization and upscaling of GMP-compatible manufacturing processes for lyophilization of biologics (e.g. Anti-body drug conjugates, ADCs), incl. preparation and documentation of development activities
• Creation of risk analyses and statistical design of experiments (DoE) within the framework of formulation and process development of biologics
• Co-working with a young development team for developing and extending the department analytical capabilities with focus on physicochemical characterization of Biologics, as well as the occupational health and safety concepts for handling of high potent compounds
• Functional and technical management of contract manufacturing organizations (CMOs) for clinical trials material manufacturing, as well as technology transfers to in-house manufacturing sites and CMOs in Europe, incl. on-site support
• Supporting the team in creating and reviewing manufacturing protocols and reports
• Support the preparation of regulatory submission documents; incl. NDA, and BLA.
• Collaboration with various international multidisciplinary project teams (incl. colleagues from Japan, US and CMOs in Europe)

Profil

• University degree in Pharmacy or related subject, ideally with PhD in Pharmaceutical Technology (focus on Lyophilization and Biologics)
• At least two years of relevant work experience in pharmaceutical industry (formulation and process development).
• Previous experiences with CMO management, global CMC development, technology transfer and handling of high potent Biologics are preferrable.
• Experience in Design of Experiments and upscaling of GMP-compatible manufacturing processes (Fill and Finish)
• Previous expertise in CMC regulatory requirements and submissions
• Very good written and oral communication skills in English and German
• Very good IT skills (MS Office, SAP etc.)
• Willingness to travel on business trips, if needed

Wir bieten

• Excellent Benefits
• Work-Life Balance
• Growth and Development
• Health and Wellbeing Support

Important note

Please be advised that a valid work permit for Germany is required for non-EU citizens. Unfortunately, applications without a valid work permit and sufficient German language skills may not be considered.