Imp Supply Manager
il y a 13 heures
**Description**:
We are looking for an experienced IMP supply Manager to support the development of our investigational drug programs. The IMP supply Manager will manage IMP supply chains to ensure uninterrupted drug supply throughout the clinical studies at sites worldwide and according to project plans. This position will report to the Head of CMC.
**Key Responsibilities**:
**What will you do?**
- You will develop, implement and manage an IMP Supply Plan that is in alignment with the overall Project plan and Clinical study timelines. The IMP supply plan will be developed in collaboration with the Clinical study team and the CMC team
- You will select and manage Clinical Supply vendors and keep oversight of their activities
- You will make proposals for suitable kit design based on the clinical study design and create Master labels;
- You will forecast the demand of the different IMPs and non-IMPs for the clinical development programs both initially and on an ongoing basis throughout the clinical development program
- You will contribute to RTSM set up by advising on site and depot supply and resupply parameters;
- You will ensure that the Product Specification File for the IMP supply activities is kept up to date;
- You will ensure that all work is conducted in accordance with applicable policies and procedures, cGMP and regulatory standards & guidelines
- You will review and approve internal and vendor documents related to IMP supply
- You will lead and participate in initiatives for improving functional processes and technical operations.
**Skills, Knowledge and Expertise**:
- You have experience in working in an outsourced model with external vendors
- You have good understanding of drug development, clinical trials management and related supply, quality and regulatory requirements.
- You are comfortable with electronic records & digital workflows;
- You are capable of working well independently under mínimal supervision as well as in a team;
- You are flexible and able to multitask, prioritize, meet deadlines in a fast-paced environment;
- You are an open-minded individual with interpersonal abilities;
- You speak and write English fluently;
- You are willing to travel occasionally.
**Benefits**:
- The opportunity to develop **pioneering science in a young biotech company**;
- Challenging and innovative work environment as part of a driven team;
- Flexibility and responsibility with remote working options that can be tailored for you;
- Competitive salary and benefits;
- An agile and fast paced environment.
**About Agomab**:
Agomab is a young and dynamic biotech company developing medicine for patients with inflammatory and fibrotic diseases, including Crohn’s disease.
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