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

RxREVU, Inc.; Doderhof; Vor Ort; EUR 120.000 - 170.000; Vollzeit

Zusammenfassung

Daiichi Sankyo in Germany seeks a Manager Formulation Technology - Biologics to lead development activities for parenteral biologics, including lyophilization, and to oversee CMO management and regulatory submissions. You will drive upscaling and tech transfers across Europe, and collaborate with international teams in Japan, US and CMOs.

The role requires a PhD in Pharmaceutical Technology or a related field, 2+ years in pharma formulation and process development, and strong English and German

Qualifikationen

• University degree in Pharmacy or related subject, ideally with PhD in Pharmaceutical Technology (Lyophilization/Biologics).
• At least two years of relevant work experience in pharmaceutical industry (formulation and process development).
• Experience with CMO management, global CMC development, tech transfer and handling high potent Biologics preferred.
• Experience in Design of Experiments and upscaling GMP manufacturing processes (Fill and Finish).
• Experience with CMC regulatory requirements and submissions.
• Strong written and spoken English and German.
• Strong IT skills (MS Office, SAP).
• Willingness to travel as needed.

Aufgaben

• Develop, optimize and scale GMP-compatible lyophilization processes for biologics.
• Create risk analyses and DoE designs for formulation and process development.
• Collaborate with a young team to extend analytical capabilities for Biologics.
• Manage CMOs for clinical trials material and tech transfers to Europe sites.
• Support preparation of regulatory submissions (NDA/BLA) and reports.
• Coordinate cross-functional projects with teams in Japan, US and Europe.

Kenntnisse

English & German proficiency

Communication skills

IT skills

Willingness to travel

Ausbildung

University degree in Pharmacy or related subject

PhD in Pharmaceutical Technology

Tools

MS Office

SAP

Jobbeschreibung

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

Job Requisition ID: 1999

Posting Start Date: 8/11/26

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.

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.

Key responsibilities

• 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)

Personal skills and professional experience

• 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

Why work with us?

Working at Daiichi Sankyo is more than just a job - it is your chance to make a difference and change patients' lives for the better. We can only achieve this ambitious goal together. That is why we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the opportunity to grow, think boldly, and contribute your ideas. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.