Head of Manufacturing CGT (m|f|d)

Miltenyi Biotec; Bergisch Gladbach; Vor Ort; EUR 85.000 - 120.000; Vollzeit

Zusammenfassung

A biopharmaceutical company in Bergisch Gladbach is seeking an experienced Head of Manufacturing to lead CDMO manufacturing operations. You will ensure regulatory compliance, oversee production planning, and mentor a high-performing team. The ideal candidate has extensive experience in manufacturing medicinal products and is fluent in both English and German while demonstrating strong leadership and collaborative skills.

Leistungen

Flexible on-site work

Employee events

30 days of vacation

Corporate sports activities

In-house Training Academy

Qualifikationen

• Extensive experience in the manufacture of medicinal products or advanced therapies, including several years in a management position.
• In-depth knowledge of GMP for ATMPs, aseptic processes, and cell production.
• Fluent in English and German.

Aufgaben

• Lead and manage manufacturing operations ensuring adherence to GMP, EMA, and FDA regulatory standards.
• Oversee production planning, batch execution, and technology transfer for CGT products.
• Support audit readiness and represent Manufacturing in regulatory inspections.

Kenntnisse

Leadership

Team building

Communication

Problem solving

Collaboration

Ausbildung

Degree in biotechnology, bioprocess engineering, pharmaceutical sciences or related field

Jobbeschreibung

We are seeking an experienced and inspiring Head of Manufacturing to oversee CDMO manufacturing operations at our Cell & Gene Therapy (CGT) site in Bergisch Gladbach. As the leader of this important team you will oversee daily operations ensure regulatory compliance and drive the successful production of advanced therapy medicinal products (ATMPs).

You will collaborate closely with the Quality Process Development Supply Chain and Engineering teams to establish robust compliant and efficient manufacturing processes that deliver transformative therapies to patients.

Key responsibilities

• Lead and manage manufacturing operations ensuring adherence to GMP EMA and FDA regulatory standards.
• Oversee production planning batch execution and technology transfer for CGT products.
• Partner with cross-functional teams to ensure readiness for clinical and commercial manufacturing.
• Support audit readiness and represent Manufacturing in regulatory inspections.
• Drive operational excellence through lean manufacturing principles digitalisation and workforce development.
• Build and mentor a high-performing manufacturing team fostering accountability and professional growth.

Qualifications

• Degree in biotechnology bioprocess engineering pharmaceutical sciences or a related field; higher degree preferred.
• Extensive experience in the manufacture of medicinal products or advanced therapies including several years in a management position.
• In-depth knowledge of GMP for ATMPs aseptic processes and cell production.
• Proven track record of successfully leading teams in a clinical or commercial production environment.
• Strong collaboration communication and problem-solving skills.
• Fluent in English and German.

What we offer

• Flexible on-site work: Enable time management on your terms
• Diversity: International teams and cross-border intercultural communication
• Room for creativity: Its most clever solution that we always strive for
• Health & Sport: Corporate sports activities and health provision
• Miltenyi University: A clever mind never stops learning take advantage of our inhouse Training Academy
• Corporate benefits: Employee events 30days of vacation (e)-bike leasing company pension plan and many other offers

If you are passionate about the purpose of your code and enjoy working in a supportive team culture then please do not hesitate to join us in our great vision and make a real difference to peoples lives.