Project Manager

Il y a 2 mois

Colmar, France PPRS Temps plein

PPRS is an independent company specialized in the development of innovative projects with diagnostic or therapeutic purposes in various therapeutic fields.

Working at PPRS means evolving within an open, dynamic team in recent and comfortable offices and interactive and social work environment close to Colmar train station, but also benefiting from advantageous complementary health insurance 100% covered by the company (_family/children/partner included_).

We are looking for a “Project Manager” for our Alsace-based offices.

As part of the non-clinical team you will work in close relationship with the other experts and will contribute to the project with an integrated vision.

Assist the director in overall pharmaceutical development and clinical drug supply activities which consist of:

- Lead early to late-stage drug substance and drug product development and validation for multiple programs in a 100% out-sourced environment
- Design, conduct and coordinate development and optimization of Drug Substance manufacturing Drug Product Formulation
- Provide technical expertise input on formulation development strategies and formulation solution to develop phase-appropriate drug product for preclinical, clinical and future commercial use
- Participate in the process of identification, qualification, selection and contracting out with CDMO for Drug Product development and manufacturing according to specific project needs
- Act as technical interface to guide CRO/CDMO to design Drug Substance(s) development and Drug Product(s) formulation and manufacture drug product
- Interfaces with Sponsor and internal project teams, and with external suppliers as necessary to plan and coordinate the timely execution of CMC activities in accordance with the overall project plan.
- Supervise / coordinate drug supply activities for Phase I to III clinical trials

**Profile**:

- Ideally PharmD or PhD in Pharmaceutical Industry, junior profiles accepted
- Training in GMP and GLP
- Knowledge of clinical development, clinical trials design and GCP would be a plus
- Excellent oral and written communication skills
- Will to learn
- Professionnal English
- Flexibility and versatility

**Location**:
Colmar

**Type of contract**:
Permanent contract

**Reference**:
PM2024_02

**Salary**:
Starting 33K€ (depending on profile)

Type d'emploi : CDI
Statut : Cadre

Salaire : à partir de 33 000,00€ par an

Avantages:

- Prise en charge du transport quotidien
- RTT
- Travail à domicile occasionnel

Programmation:

- Du lundi au vendredi
- Repos le week-end
- Travail en journée

Langue:

- Anglais (Requis)

Lieu du poste : En présentiel

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