Process Development Engineer (M/F) > JR France > Joboolo FR :

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Medincell

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841225315646911283232761

1

16.05.2025

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

We are seeking a Process Development Engineer to join our Process Development and Manufacturing team, which primarily focuses on scaling up formulation processes for clinical batches, designing manufacturing equipment, and managing outsourced activities.

Responsibilities

• Deploy process and technology transfer for manufacturing injectable formulations through scale-up to GMP clinical stage Contract Development & Manufacturing Organizations (CDMOs).


• Conduct literature searches to solve manufacturing problems and recommend improvements.


• Contribute to defining Critical Process Parameters (CPP) and Critical Quality Attributes (CQA) for each project.


• Optimize processes and establish sterilization procedures for drug products in vials, prefilled syringes, and cartridges.


• Assess and implement optimal process conditions to ensure product stability.


• Achieve technology transfer milestones on time, maintaining quality standards.


• Plan logistics for experiments, conduct them, and analyze results to guide project decisions.


• Collaborate effectively with CDMOs during product transfer activities.


• Ensure compliance with industrial engineering standards and optimize capital investments and operational efficiencies.

Quality Assurance

• Align operational processes with safety, operational standards, and regulatory requirements.


• Maintain data traceability and integrity.


• Support resource management for process equipment, including maintenance and training.


• 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.


• Contribute to Requests for Proposals for process activities.

Profile

Experience

• At least 5 years in process development, engineering, technology transfer, scale-up, and GMP clinical manufacturing of liquid sterile injectables.


• Experience with long-acting injectables is a plus.


• Previous engineering experience in process development for injectable pharmaceuticals.

Qualifications

• Master’s degree in chemical engineering, process engineering, or related fields.


• Expertise across manufacturing processes and equipment from pilot to commercial scale.


• Knowledge of successful technology transfer activities and documentation.

Languages

• Fluent in French and English, with strong communication skills for meetings and reports.

Additional Skills

• Strong knowledge of regulatory requirements, pharmaceutical guidelines, and standards, especially in injectable products.


• Experience in raw material compounding and drug manufacturing.


• Results-oriented with a focus on timely delivery and urgency.


• Ability to prioritize within budgets and constraints.