Senior Process Development Engineer (Pharmaceutical) (M / F)

Medincell; Montpellier; Sur place; EUR 60 000 - 80 000; Plein temps

Résumé du poste

A pharmaceutical company in Montpellier is seeking an experienced Senior Process Development Engineer to enhance their Process Development and Manufacturing team. The role involves scaling up formulations for injectable drugs, ensuring compliance with safety and regulatory standards, and optimizing processes. A Master’s degree in chemical or process engineering and fluency in French and English are required. This position offers a dynamic work environment focused on innovation in drug development.

Qualifications

• 5+ years in process development, engineering, and GMP manufacturing of sterile injectable drugs.
• Experience with long-acting injectables is a plus.
• Fluent in French and English, capable of complex meetings.

Responsabilités

• Deploy process and technology transfer for injectable formulations.
• Conduct literature searches to solve problems and recommend improvements.
• Ensure compliance with safety and regulatory requirements.
• Maintain thorough documentation of technical activities.

Connaissances

Process development

Technology transfer

GMP manufacturing

Fluent in French and English

Regulatory requirements knowledge

Results-oriented

High autonomy

Formation

Master’s degree in chemical or process engineering

Description du poste

MedinCell is a pharmaceutical company at the commercial stage that develops innovative long-acting injectable medicines based on our BEPO technology.

We are seeking a Senior Process Development Engineer to join our Process Development and Manufacturing team, which primarily focuses on scaling up formulations for clinical batch manufacturing. The team also designs equipment for manufacturing processes and manages outsourced activities.

Missions

Process Development and Manufacturing

• Deploy process and technology transfer for manufacturing injectable formulations, including scale-up to GMP clinical stage CDMOs.
• Conduct literature searches to solve problems and recommend process improvements.
• Provide technical input for creating CPP (Critical Process Parameters) and CQA (Critical Quality Attributes).
• Design process development activities.
• Optimize processes and define sterilization methods for drug products in vials, prefilled syringes, and cartridges.
• Assess and implement optimal process conditions for in-process stability.
• Ensure timely achievement of technology transfer milestones with quality compliance.
• Plan logistics, conduct experiments, and analyze results to guide project decisions.
• Establish effective relationships with CDMOs for product transfer activities.
• Oversee engineering standards, capital investments, and operational efficiencies.
• Contribute to the engineering function from design to strategy implementation, utilizing internal and external resources.

Quality Assurance

• Ensure processes comply with safety, operational standards, and regulatory requirements.
• Maintain data traceability and integrity.
• Ensure adequate resources and training for process equipment management.
• Select vendors for equipment management and maintenance.
• Report and manage quality events according to SOPs.
• Stay updated on relevant guidelines and regulations.
• Maintain thorough documentation of technical activities.
• Assist in preparing Requests for Proposals for process activities.

Profile

Experience

• At least 5 years in process development, engineering, technology transfer, scale-up, and GMP manufacturing of sterile injectable drugs.
• Experience with long-acting injectables is a plus.
• Previous process development and transfer experience for injectable pharmaceuticals.

Qualifications

• Master’s degree in chemical or process engineering or related field.
• Knowledge of manufacturing processes from pilot to commercial scale.
• Understanding of technology transfer success factors and activities.

Languages

• Fluent in French and English, capable of participating in complex meetings and writing reports.

Additional Skills

• Strong knowledge of regulatory requirements, pharmaceutical standards, especially for injectables.
• Experience in compounding raw materials and manufacturing drug products.
• Results-oriented with a focus on timely delivery and urgency.
• Ability to operate within budget and priorities.
• High autonomy.