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 Biological CMC Consultant (M/F/X).

Responsibilities
As a CMC Project Manager Consultant in Pharmaceutical Development at Inits, you will play a key role in supporting our clients throughout the development phases of their pharmaceutical products, from the early stages (Phase I preparation) through to the validation and product registration stages. Your main responsibilities will include:

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

• Project management: Coordinate and monitor the various stages of projects in collaboration with internal and external teams, ensuring that deadlines, budgets, and objectives are met.

• Reporting and communication: Implement monitoring and reporting tools, and ensure clear and regular communication with stakeholders regarding the progress of activities.

Your main responsibilities include:

• Defining CMC strategies: Develop CMC development plans aligned with current regulatory requirements, taking into account the specific characteristics of each project.

• Selecting and collaborating with CDMOs and CROs: Actively participate in the selection of CDMOs (Contract Development and Manufacturing Organizations) and CROs (Contract Research Organizations) and closely monitor their pharmaceutical activities.

• Overseeing CMC activities: Monitor and coordinate key stages, including the development of processes and analytical methods, product manufacturing (intermediates, active, and finished product), quality control, stability studies, and the validation of processes and analytical methods, ensuring compliance with quality standards and deadlines.

• Document review: Review documents generated as part of development, validation, and GMP manufacturing activities.

• Regulatory Support: Assist clients in preparing and reviewing regulatory documents, such as:

  • Briefing books for discussions with regulatory authorities

  • IMPD/IND (Investigational Medicinal Product Dossier / Investigational New Drug) dossiers

  • BLA/MAA (Biologics License Applications / Marketing Authorization Applications)

  • Protocols and reports related to the project.

• Reporting and Communication: Prepare regular, clear reports on project progress and ensure smooth communication with clients to guarantee their satisfaction and engagement.

• Project Tracking: Track time spent on projects to stay within the allocated budget and meet project deadlines

• Perform all other tasks assigned by management.

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

You hold a science degree with a specialization in pharmaceuticals or biotechnology (university degree, engineering degree, or pharmacy degree) and have at least 6 years of experience in the development of biological drugs.

You have a comprehensive understanding of the pharmaceutical industry, including its major challenges (quality, patient safety, regulatory compliance, and industrial performance), as well as in-depth expertise in at least one key area of CMC (processes, analytics, drug substance, drug product, etc.).

You are well-versed in the sector’s regulatory and standards frameworks (GMP, ICH guidelines, requirements of health authorities) and know how to analyze business processes to identify gaps, risks, and opportunities for improvement.

With a keen sense of support, you are able to guide clients in achieving regulatory compliance and optimizing their practices.

Meticulous and organized, you draft and structure technical deliverables (audit reports, assessments, procedures, action plans, presentation materials) and apply project management methods to ensure the tracking of actions and adherence to deadlines.

Finally, you adapt to a variety of contexts (multi-site, international, short- or long-term assignments,operational or strategic) and are proficient in office and collaboration tools (Microsoft Office suite, reporting tools, document-sharing solutions).

You have excellent interpersonal, listening, and communication skills, as well as the ability to work independently, demonstrate adaptability, and maintain a strong sense of responsibility. Your analytical and synthesis skills, combined with a pragmatic approach, enable you to work effectively as part of a team and manage priorities with discernment. You have a good command of English.

Employment Terms

Salary based on qualifications

Benefits: Variable performance-based bonus, standard vacation bonus, 84% coverage of the cost of health insurance, profit-sharing, employee savings plan (PEE), inter-company daycare, and Time Savings Account.

Join a friendly and professional team where everyone contributes to the company’s growth.

The offices are located in MAUGUIO. Remote work is possible.

Come join the Inits adventure!