Functional head of quality control [§12 AMWHV] (m|f|d) at Miltenyi Biotec

Bergisch Gladbach, North Rhine-Westphalia, Germany -

Full Time

Start Date

Immediate

Expiry Date

29 Jul, 26

Salary

0.0

Posted On

30 Apr, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

GMP, Quality control, ATMP, Flow cytometry, qPCR, Endotoxin testing, Microbiological testing, Equipment qualification, Validation, SOP creation, Auditing, Cell-based therapy, Regulatory compliance, Analytical methods, Team leadership

Industry

Biotechnology Research

Description

Company Description For more than 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 5,000 experts from over 75 countries contribute to our sustainable success. Job Description Your role Together with the teams from manufacturing, quality assurance and development, you will create a dynamic GMP environment in which collaboration and innovation are practiced daily. You ensure that all starting materials, intermediate products and finished products are checked and released/blocked according to specifications and carry out the functional tasks of a head of quality control in accordance with §12 AMWHV You ensure that the necessary test procedures are validated in the operational teams and that all necessary tests as part of development projects and release tests are carried out and documented in accordance with GMP. You are responsible for qualifying equipment and validating computer-based systems You are proactively involved in the continuous improvement and increase in efficiency of our processes, create GMP-relevant SOPs and thereby always ensure our high quality standards for our therapeutic products. You will be involved in self-inspections and audits by customers and monitoring authorities and will subsequently process open activities and anomalies Qualifications Your profile You have successfully completed your science studies. You have already gained several years of professional experience in quality control of cell-based ATMPs and have extensive experience under GMP. You have already worked as head of quality control in accordance with §12 AMWHV or fulfill the requirements to complete your training in this direction and are ready to take on this responsibility for ATMPs. You have a strong understanding of analytical methods in the quality control of cell-based ATMPs such as flow cytometry, qPCR analyses, endotoxin tests and microbiological tests. You work in a structured, prudent and solution-oriented manner - even in challenging situations - and are characterized by a high level of quality and responsibility and motivate your team to achieve top performance. Due to the timely analysis required as part of CAR-T cell therapy, you have a strong willingness to work both early in the morning and in the late afternoon or evening if necessary Your English skills are fluent, spoken and written, so that you can move confidently in an international environment. Skills in speaking, reading, and writing German are desired and are a plus Additional Information What we offer Diversity: International teams and cross-border intercultural communication Room for creativity: It’s the most clever solution that we always strive for Health & Sport: We offer a wide range of corporate sports activities and health provision Miltenyi University: A clever mind never stops learning, take advantage of our in-house Training Academy 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. Become part of our team and focus on pushing the borders of medicine. Contact us If you have the skills and qualifications for this position, please use the link to send us your details (application letter, curriculum vitae, references and certificates). Please give us some idea of when you can start and the kind of salary you are looking for. Department: Quality Control Cell Factory BGL Location: Bergisch Gladbach Functional Area: Qualitymanagement Company: Miltenyi Biotec B.V. & Co. KG

Responsibilities

You will serve as the functional head of quality control under §12 AMWHV, ensuring all products are tested and released according to GMP standards. Additionally, you will manage equipment qualification, process validation, and participate in audits and self-inspections.