Group Leader CDMO Manufacturing CGT (m|f|d) at Miltenyi Biotec

Bergisch Gladbach, North Rhine-Westphalia, Germany -

Full Time

Start Date

Immediate

Expiry Date

01 Feb, 26

Salary

0.0

Posted On

04 Nov, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

GMP Compliance, Aseptic Processes, Cell Production, Team Leadership, Collaboration, Problem-Solving, Manufacturing Operations, Regulatory Standards, Production Planning, Batch Execution, Technology Transfer, Operational Excellence, Lean Manufacturing, Digitalisation, Workforce Development, Quality Assurance

Industry

Biotechnology Research

Description

Company Description For 35 years, we have been developing cutting-edge science and technology to empower biomedical research and personalized medicine. We combine excellence from more than 60 disciplines in natural sciences, engineering, and informatics to make a significant contribution to biomedical sciences. We encourage a creative working environment driven by pioneering spirit – to seek new horizons – boldly envisioning the future and turning it into reality. Today, more than 4,900 experts from over 50 countries contribute to our sustainable success. Job Description We are seeking an experienced and inspiring Group Leader 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. Additional Information What we offer Flexible on-site work: Enable time management on your terms Diversity: International teams and cross-border intercultural communication Room for creativity: It’s the 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, 30 days of vacation, (e)-bike leasing, company pension plan and many other offers Diversity is the bedrock of our creativity. Our mission: To innovate treatments and technologies and tackle the world’s most serious health challenges. And that’s why we connect the dots –across various disciplines, linking different perspectives, skills, and abilities. You and your talent are welcome here in our inclusive and collaborative environment. So come as you are. Regardless of gender, sexual identity, age, ethnicity, religion or disability. Contact us 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 people's lives.

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.