📌 Main Mission

The Analytical Project Manager (M/F) develops and validates analytical methods for the characterisation, quality control and stability of pharmaceutical products under development.

They contribute to the design and implementation of analytical studies required for formulation development, regulatory dossiers and clinical batches, in compliance with GMP and regulatory requirements.

They act as Project Manager and will also manage a team of Analytical Technicians.

🎯 Main Responsibilities

• Ensure the conduct of analytical projects

• Develop, optimise and validate analytical methods for the identification, purity, content, impurities and stability of active substances and pharmaceutical forms.

• Perform physico-chemical analyses and write the associated documentation (protocols, validation reports, operating procedures…).

• Contribute to writing the analytical sections of regulatory dossiers (CTD modules 2 and 3).

• Participate in feasibility, compatibility and stability studies (ICH) on products under development.

• Ensure the maintenance and qualification of analytical equipment (HPLC, UPLC, GC, IR, UV, dissolution…).

• Supervise a team of Analytical Technicians

• Expertise in conducting and following up on audits

• Guarantee the compliance of analytical activities with quality standards (GMP, ICH Q2, pharmacopoeias).

• Collaborate closely with the formulation, pilot production, quality and regulatory affairs teams.

• Ensure scientific and technological monitoring in their field of expertise.

 🧩 Profile Sought

Education:

• Master's degree (chemical engineer, master's in analytical chemistry, pharmacy, biotechnology) or PhD in analytical chemistry or pharmaceutical sciences.

Experience:

• Minimum of 8 years of experience in a similar role in analytical development in the pharmaceutical, biotechnological or chemical industry, and in project management and team management.

• Experience in a regulated environment (GMP) is a plus.

Technical Skills:

• Mastery of reference analytical techniques: HPLC/UPLC, GC, dissolution, spectroscopy (UV, IR, MS…).

• Knowledge of applicable guidelines and standards (ICH, GMP, USP/EP/JP pharmacopoeias…).

• Good written and oral communication skills in French and English.

Personal Qualities:

• Scientific rigour, organisational and documentation skills.

• Analytical and synthesis mind.

• A taste for teamwork, leadership and communication skills.