Adress The BioInvent team covers all aspects of drug development, including discovery, preclinical and translational research, manufacturing, and clinical development.
Together we are creating the exciting future of BioInvent, and we welcome you to be part of it as
Experienced Drug Supply Manager
to BioInvent´s Clinical Development Team
Main Responsibilities
As Drug Supply Manager you will manage clinical study drug activities across studies and projects according to timelines and company milestones, including but not limited to:
Establish, monitor, and maintain internal procedures (e.g. SOPs) at BioInvent related to IMP management.
Be responsible for external CMO selection and oversight across BioInvent studies.
Coordinate, prepare, approve, and file documentation related to trial medication.
Work on drug demand forecasting, planning and distribution strategy of clinical trial supply.
Closely collaborate with all relevant parties at BioInvent.
Provide input to IMP packaging design.
Contribute to review relevant sections in the clinical trial protocols and amendments.
Generate and update IMP manuals.
Timely manage deviations related to IMP and AxMP at site, during shipment or at CMO.
Perform Risk Management related to IMP and AxMP.
Assist in product complaints and recall/mock recall.
Qualifications
At least 3 years' experience in clinical trial Drug Supply management or clinical trial management at a bio/pharmaceutical company.
Bachelor's Degree in Life Sciences, Business, Engineering, Supply Chain Management, MSc is desirable.
Excellent verbal and written communication skills in English
Proficient in MS Word, Excel, Power Point, Outlook, and MS Project.
Experience in CMO oversight, contract, and budget negotiations.
Deep knowledge about ICH-GCP and GMP related to IMP.
We are looking for a driven, structured, self-motivated, independent, and responsible person, who understands complex projects and interdependencies and easily collaborates and communicates with others both verbally and in writing. You have excellent problem solving and negotiation skills and you enjoy creating efficient working methods and contributing with your experience to ensure continuous improvements.
Personal suitability is of great importance, we nurture a culture of teamwork, positive team spirit and promote the development of each member in the team. We believe that you are efficient, have a strong commitment and ability to make things happen. You understand the importance of achieving results, keeping deadlines, and securing high quality within your work. You are enthusiastic and enjoy creating results and achieving goals both individually and together with your teams.
The position is office-based in Lund. However, the position may also offer a flexible working arrangement.
Starting Date: as soon as possible
Application
BioInvent has several value driving factors in place with great potential for the future. If you match the described profile and would like to contribute to important cancer research, you are welcome to apply for the position!
Please send us your application, personal letter and CV and tell us why you are the right person for this position, at the latest 7th of April 2024.
