Cdmo Management Project Manager

il y a 1 mois

Dreux, France Ipsen PharmSciences SAS Temps plein

Ipsen is a global biopharmaceutical group dedicated to improving lives and health outcomes through innovative medicines in Oncology, Neuroscience and Rare Disease. We are committed to discovering new treatments in areas with high unmet medical needs and improving the quality of life for patients.

**Research and development are key elements of our strategy, reflecting our commitment to improving patients’ lives and health outcomes.** Bolstered by a culture of collaboration & excellence, Ipsen offers a unique proposition to 5,700+ employees committed to society.

The **Pharmaceutical Development **organization is located across 5 Sites (France, UK, Ireland, US and Canada). The position is global and currently located in Europe. Regular presence at the Dreux site is expected.

In respect to Good Manufacturing Practices and as part of the Drug Product Development department, the **Clinical supply chain CDMO Project Manager**
- manages the realization of all clinical packaging and distribution operations when outsourced
- supports the Clinical Supply Chain CDMO Management Lead to set up robust collaborations with vendors to supply materials required for the conduct of clinical studies
- performs his / her mission according to (i) the up-to-date internal and external regulatory guidance and process, (ii) and within time, resources and cost agreed by the company.

This entails to be strongly involved in the continuous improvement process and knowledge management relating to the development of NCEs and Life cycle management of commercial products within the DPD department.

**MAIN RESPONSIBILITIES**

**Clinical packaging and distribution responsibilities**
- According to the clinical forecasts / timelines, and in collaboration with **CDMOs** and **Clinical Supply Chain Therapeutic Area groups**, define the planning for packaging, labeling and distribution for studies outsourced and to ensure the on-time supply to patients with no stock outs of IMPs
- Assess the impact of changes in clinical studies on planning and propose mitigation plans accordingly
- Coordinate and lead meetings with CDMOs in charge of clinical packaging and distribution
- Monitor CDMOs performance through KPIs
- In collaboration with the **Suppliers Quality Assurance department**, set up and maintain of Quality Technical Agreements
- Ensure the on-time availability of the documents required for his/her activities, i.e. instructions, batch records, reports, specifications
- In collaboration with the **Operational Quality Assurance team**, ensure the review of the batch records and instructions of clinical IMPs
- Manage quality events (deviations, change controls) in line with defined KPIs,
- Ensure activities are performed as per the agreed budget and with respect to the procurement processes : request quotes, launch commitment requests and place purchase orders
- Ensure vendors are paid in due time and based on diligent invoices review
- Develop/maintain a network of efficient CDMOs / vendors to ensure his / her activities
- Implement and maintains robust collaboration with vendors to procure comedications and / or comparators
- Implement and maintains robust collaboration with vendors to supply materials required to support clinical packaging and distribution activities when performed internally (booklet labels, packaging materials, etc)
- Present the results and progress of projects under his/her responsibility at internal technical meetings
- Ensure regulatory surveillance related to his / her activities (guidelines, GMP, Annex 13, Annex 1)
- Develop and optimize the team’s interfaces within **GCSM** as well as with the Operational Quality Assurance and Drug Product Management team

**Continuous improvement**
- Support the **Process and Compliance Project Manager** while defining and / or adjusting GCSM processes / ways of working and providing effective as well as continuous feedback.
- Organize and actively participate in lessons learnt exercises when needed.
- Contribute to continuous improvement projects within the Global Clinical Supply Management Department and/or wider Pharmaceutical Development.
- Be a promoter of continuous improvement processes and to guarantee the method.

**QEEHS Responsibilities**:

- Respect the Good Practices applicable (BPF, BPD,), the rules of Energy Environment Health and Safety through the procedures applicable within the company.

**CSR Responsibilities**:
**KNOWLEDGE, ABILITIES & EXPERIENCE**:
Education / Certifications:

- Pharmacist, engineer or university graduate (BAC+5), degree in science or equivalent

**Experience**:

- Minimum 5 years’ experience in an equivalent job in the Pharmaceutical Industry

Languages:

- Fluent in English to effectively interface with English-speaking subcontractors

**KEY TECHNICAL COMPETENCIES**:
**Technical skills**:

- Strong experience and knowledge on GMP and cGMP,
- Excellent communication skills,
- Experience in project management,
- Experience in CDMO manag

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