Project Manager in Pharmaceutical Development

About AELIS FARMA
Aelis Farma’s goal is to develop a new pharmacological class: the signaling specific inhibitors of the CB1 receptor (CB1-SSi). CB1-SSi have a unique MOA that has never been tested in humans before. Aelis Farma develops today two candidate drugs AEF0117 (currently in phase II) for the treatment of cannabis abuse and cannabis-induced psychosis and, AEF0217 for the treatment of the cognitive impairment in Down syndrome. Aelis Farma is extremely committed to develop these breakthrough treatments and has the ambition to become the leader in SSi drugs.
We are looking for a project manager in pharmaceutical development with a background on Small Molecule development to work on the externalized CMC activities (Chemistry Manufacturing and Control). We need either a process chemist or formulation scientist with experience ideally in CDMO.
The project manager will be responsible for the management of the successful manufacture of the pharmaceutical product (Drug substance and/or Drug Product) as well as the supply of the clinical sites.
He will also write and keep the regulatory files updated.

Job Functions / Responsibilities:

As part of a dynamic team and in a stimulating environment, you have a very polyvalent position directly attached to the Head of department. As such, you will be responsible for the following tasks:

• Ensure the implementation and monitoring of the pharmaceutical development plan defined with the management team
• Coordinate and monitor the manufacturing and release of pilot and clinical batches of both “drug substance” and “drug product”. Analyze, interpret, and verify the consistency of the results with the expected specifications of the products
• Select, manage, supervise the Drug substance and/or Drug Product activities at our external partners (CDMOs),
• Coordinate with internal teams (CMC, regulatory affairs, toxicology, clinic, portfolio management) for the execution of the drug substance and product development - Ensure good performance in terms of quality in accordance with regulations (BPF, GMP, USP, EUP). Contribute to ensuring the quality control of products developed and manufactured by subcontractors for future clinical use,
• Be the guarantor of the quality and the good realization of the processes developed with international CMOs. Ensure that deadlines and costs are met as defined in advance with the management team.
• Write the regulatory documents required for regulatory submissions (IND and IMPD), registration files as well as technical parts of technical files and product information file
• Carry out a technical and technological monitoring, documentary and bibliographical research
• Participate in the development of the company's patent portfolio by contributing to the filing of new patents (new applications, technology,…).

Key Requirements and qualifications :

• A relevant degree (PharmD, MSc or PhD), you have minimum 5 years of experience in a similar position in an industrial environment (Pharmaceutical industry, biotechs)
• Knowledge / mastery of manufacturing processes for “drug substance” and/or “drug product” batches in GMP environments Solid understanding of pharmaceutical regulations, quality constraints and good laboratory practices
• Good team skills and ability to work in an interdisciplinary and international environment.
• Independence and responsibility in decision making and task execution in project management of pharmaceutical development.
• Excellent oral and writing communication skills (English and French)
• High personal culture and work ethics

Position to be filled as soon as possible.
Please submit the documents in English (CV and a cover letter). Selected candidates will be invited for an interview.
Statut : Cadre
Job Types: Full-time, Permanent, Presential