Associate IMP Manager (m|f|d) at Miltenyi Biotec

Bergisch Gladbach, North Rhine-Westphalia, Germany -

Full Time

Start Date

Immediate

Expiry Date

06 Jan, 26

Salary

0.0

Posted On

08 Oct, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Research, Clinical Trial Management, Cell Therapies, Regulatory Compliance, Documentation, Drug Accountability, Process Improvement, Interpersonal Skills, Communication Skills, Attention to Detail, Organization, Team Player, Initiative, Independent Work, Dynamic Environment, Apheresis

Industry

Biotechnology Research

Description

Company Description Miltenyi Biomedicine is a biopharmaceutical company committed to advancing personalized cell and gene therapies. We are pioneering groundbreaking therapies for serious life-threatening diseases, and reshaping their accessibility for clinical professionals and patients worldwide with the aim to improve and extend patients' lives. We are currently focusing on difficult-to-treat hematological cancers using CAR-T and other technologies, while also exploring treatments for other diseases. Our lead candidate, a tandem CAR T-cell product, is currently undergoing pivotal clinical trials on a global scale. Join our highly professional team in bringing new medicines to market and ensuring the safety of our pharmacological developments at all stages. Job Description You are working in the department “Clinical Development Europe” which is performing clinical trials in the field of cellular therapies. As an Associate IMP Manager, you will be part of in the Clinical Trial Execution Service group working closely with the IMP Managers to support the operational daily business regarding Investigational Medicinal Products topics within the clinical trials. As an Associate IMP Manager, you will support the planning, execution, and documentation of apheresis and Investigational Medicinal Product (IMP) processes to ensure regulatory compliance and efficient delivery throughout the product lifecycle, from collection to application or destruction. You will assist in managing the lifecycle of comparator drugs and IMPs, including labeling, packaging, IWRS setup, distribution, drug accountability, and demand planning across multiple clinical trials. You will monitor and document deviations such as Out of Specification (OoS) events, escalate issues to relevant stakeholders, and support the implementation and documentation of corrective actions in collaboration with Clinical Trial Coordination and Quality Assurance. You will contribute to the development and maintenance of manuals, SOPs, and working procedures, and support training and communication with internal teams, apheresis sites, and Contract (Development) Manufacturing Organizations (C[D]MOs). You will act as a point of contact for IMP-related questions from internal and external trial teams, support process improvement initiatives, and ensure that all relevant documentation is properly filed in the Trial Master File (TMF). Qualifications You have a degree in natural sciences, e.g. chemistry, biology, pharmacy, medicine. You have already gained more than one year of experience in clinical research and/ or clinical trial management, ideally in the field of haemato-oncology and oncology, e.g. in the field of cell therapies. Attention to detail and high organization come naturally to you. You are accustomed to prioritizing multiple tasks, taking initiative, working independently, and achieving project deadlines. As a motivated and open-minded team-player with well-developed interpersonal abilities, you enjoy working in a dynamic environment. You are naturally communicative and have effective communication (verbal and written) coordination and organization skills in English. Additional Information What we offer A modern workplace in Bergisch Gladbach with opportunity for some mobile work ( 50%). Exciting opportunities in the development of technologies with a secure future. Cross-border intercultural cooperation and short communication channels A collegial corporate culture and flexible working hours enable time management on your own terms Personalized employee development program: specialist and personal training courses provided by our own Miltenyi University Diverse corporate benefits with regard to employee health, sport, and staff events We look forward to your application If you want to work in an open, creative and supportive team, this is the place for you. We look forward to receiving your application along with your salary expectations and availability.

Responsibilities

As an Associate IMP Manager, you will support the planning, execution, and documentation of apheresis and Investigational Medicinal Product (IMP) processes. You will assist in managing the lifecycle of comparator drugs and IMPs, ensuring regulatory compliance and efficient delivery throughout the product lifecycle.