Company
INITS is a dynamic consulting firm driven by quality and innovation, dedicated to supporting biotechnology companies in delivering life-changing medicines to patients. Specializing in the development and management of pharmaceutical products, INITS focuses on CMC (Chemistry, Manufacturing, and Controls), IMP (Investigational Medicinal Products), regulatory affairs, quality assurance, and audits. To support its growth, INITS is recruiting a CMC Project Manager Consultant – Pharmaceutical Development (M/F/X).

Responsibilities
As a CMC Project Manager Consultant at INITS, you will play a key role in guiding clients through the various phases of pharmaceutical product development. Your main responsibilities include:

• Strategic Support: Providing technical and strategic advice on CMC activities, ensuring compliance with regulatory requirements and industry best practices.

• Project Management: Coordinating and monitoring project milestones with internal and external teams while adhering to deadlines, budgets, and objectives.

• Documentation Review: Reviewing documents generated during GMP development and production activities.

• CDMO Selection and Collaboration: Actively participating in the selection of Contract Development and Manufacturing Organizations (CDMOs) and closely monitoring their pharmaceutical activities.

• Regulatory Support: Assisting in the preparation and review of regulatory documents, including briefing books for authority meetings, IMPD/IND dossiers, and project-related protocols and reports.

• Reporting and Communication: Establishing tracking and reporting tools, and maintaining clear, regular communication with stakeholders on activity progress.

You will be a trusted partner for our clients, actively contributing to the success of their projects and the quality of the products delivered to the market.

Profile

With at least an M2-level scientific university degree with a specialization in pharmaceuticals or a pharmacist's diploma, you have worked for at least 6 years in drug development.

You have experience of pharmaceutical development and process validation, as well as experience in biologics, biologics production processes (USP & DSP) and/or finished product production processes.

You are a good teacher and a diplomat, able to navigate in agile environments and maintain an active watch on technical and regulatory guidelines (ICH, Europe, America).

Employment Conditions

• Salary based on experience.

• Benefits: Performance-based bonus, 80% coverage of health insurance costs, employee savings plan.

• Location: Montpellier, with remote work options available.

Join the INITS adventure!