Pharmacist (m/w/d)

Daiichi Sankyo Europe GmbH; Pfaffenhofen an der Ilm; Vor Ort; EUR 90.000 - 130.000; Vollzeit

Benefits dieser Stelle

Work-Life Balance

Growth & Development

Health & Wellbeing

Zusammenfassung

Daiichi Sankyo Europe GmbH is seeking a Manager for Formulation Technology - Biologics to lead GMP lyophilization development, DoE design and tech transfer activities. You will collaborate with a cross‑functional team across Europe and with partners in Japan and the US to deliver robust biologics formulations.

The role requires a PhD or a PhD-equivalent in Pharmaceutical Technology, strong regulatory knowledge, and fluency in English and German. On-site work in Germany with potential travel.

Qualifikationen

• University degree in Pharmacy or related field; PhD in Pharmaceutical Technology preferred.
• 2+ years of relevant pharma industry experience in formulation and process development.
• Experience with CMO management, global CMC development and tech transfer.
• Experience with DOE design and upscaling GMP processes (Fill & Finish).
• CMC regulatory requirements and submissions knowledge.
• Strong English and German written and spoken communication.
• Proficient IT skills (MS Office, SAP, etc.).

Aufgaben

• Development, optimization and upscaling of GMP lyophilization for biologics.
• Create risk analyses and DoE within formulation and process development.
• Collaborate with a young team to extend analytical capabilities for biologics.
• Manage CMOs for clinical trials material manufacturing and tech transfers.
• Support preparation of manufacturing protocols and reports.
• Assist in regulatory submission documents including NDA and BLA.

Kenntnisse

Pharma experience

CMO management

Tech transfer

DOE design

CMC submissions

English & German communication

Willingness to travel

Ausbildung

Pharmacy degree

PhD in Pharmaceutical Technology

Tools

MS Office

SAP

Jobbeschreibung

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

• 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)

Requirements

• 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

Excellent Benefits

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