Technical lead - Drug Substance - EU Relocators welcome

Meet Life Sciences; München; Vor Ort; EUR 120.000 - 180.000; Vollzeit

Zusammenfassung

A leading global pharmaceutical innovator in Germany is seeking a Tech Management Lead (Drug Substance) to play a pivotal role in technology transfer and drug substance manufacturing. The ideal candidate will have a Ph.D. in a related field and extensive experience in biopharma process development, ensuring regulatory compliance. This position offers strategic influence in a collaborative, international environment that impacts patients' lives.

Qualifikationen

• Ph.D. or MSc with equivalent experience in a relevant field.
• Extensive industry experience in biopharma process development and CMC functions.
• Strong expertise in drug substance manufacturing and regulatory compliance.
• Excellent communication and leadership of cross-national teams.

Aufgaben

• Lead and coordinate site launch activities and subteams.
• Act as the main contact with manufacturing sites and CDMOs.
• Oversee tech transfer and validation activities.
• Drive data‑driven decisions, CAPAs and manufacturing improvements.
• Support CMC regulatory submissions (INDs/IMPDs/NDAs/BLAs).
• Recommend and implement new technologies to optimise processes.

Kenntnisse

Biopharma process development

Drug substance manufacturing

Tech transfer

Regulatory/GMP compliance

Leadership

Leadership

Cross-functional teams

Ausbildung

Ph.D. or MSc in biochemistry, chemistry, pharmaceutics, engineering

Jobbeschreibung

Exciting Senior Opportunity in Biopharma – Tech Management Lead (Drug Substance)

I’m currently supporting a leading global pharmaceutical innovator with a long-standing reputation in both oncology and cardiovascular therapies. With a strong international presence and a state-of-the‑art European development and production site, they are seeking an experienced professional to join their team as Tech Management Lead (Drug Substance).

This is a unique chance to play a pivotal role in technology transfer and drug substance manufacturing (with a particular focus on Antibody‑Drug Conjugates), ensuring smooth transitions from development to commercialisation.

The Role

As Tech Management Lead, you will:

• Lead and coordinate site launch activities and subteams across internal and external partners.
• Act as the main interface with manufacturing sites and CDMOs.
• Oversee tech transfer and validation activities while ensuring regulatory and GMP compliance.
• Drive data‑driven decisions, CAPAs, and continuous improvements across manufacturing performance.
• Support CMC regulatory submissions (INDs/IMPDs, NDAs, BLAs).
• Recommend and implement new technologies to optimise processes.

What We’re Looking For

• Ph.D. (or MSc with equivalent experience) in biochemistry, chemistry, pharmaceutics, engineering, or related field.
• Extensive industry experience in biopharma process development and CMC functions.
• Strong expertise in drug substance manufacturing, tech transfer, and regulatory/GMP compliance.
• Excellent communication skills and ability to work with multi‑national, cross‑functional teams.
• Proven leadership in global project and site launch teams.

Why Apply?

This is an opportunity to join a world‑class biopharma organisation at the forefront of innovation, where you’ll have visibility across global projects and make a tangible impact on patients’ lives. The role offers both strategic influence and hands‑on leadership in a highly collaborative, international environment.