Process Development Engineer (M/F)

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

We are looking for a Process Development Engineer to join our Process Development and Manufacturing team which main mission is to scale-up formulation until manufacturing process intended for clinical batches. The team also design equipment for manufacturing process and drive their management including outsourced activities.

Missions

Process Development and Manufacturing

• Deploy process and technology transfer for manufacturing of injectable formulations through scale-up to GMP clinical stage Contract Development & Manufacturing Organizations (CDMOs).
• Conduct scientific literature search to solve problems and make recommendations for manufacturing process improvement.
• Provide technical input into the creation of CPP (Critical Process Parameters) and CQA (Critical Quality Attributes) for each project.
• Design process development activities.
• Perform process optimization and define optimal sterilization process for drug products in vials, prefilled-syringes and/or cartridges.
• Assess and implement optimal process conditions to ensure in-process stability of the drug products.
• Ensure that technology transfer targeted milestones are achieved on time and Quality.
• Foresee logistics for experiments; conduct experiments; summarize and assess reported results to help decision-making process on next project steps.
• Establish effective working relationships with CDMOs in support of Product Transfer activity to CDMOs.
• Be responsible for industrial engineering standards and application to capital investments, for facility and equipment utilization, and for operational efficiencies.
• Contribute and entable the engineering function to deliver from the design, conception and strategy implementation for both internal and external resources.

Quality Assurance

• Ensure that the operational processes for Process Development and Manufacturing of drug products are aligned with the safety and operational standard procedures of the company and the regulatory requirements.
• Assure the traceability of the data to ensure their integrity and their auditability.
• Highlights appropriate resources to support the management of process equipment included maintenance and to ensure relevant training to the leader.
• Select appropriate vendors for what regards management of equipment including maintenance.
• Ensure that any quality event (e.g. deviation, HSE issue) occurring during the realization of the technical activities or during check of the fit-for-purpose fullness of process equipment is reported according to the company’s SOPs.
• Maintain updated knowledge of relevant guidelines and regulatory requirements in all phases of development.
• Maintain high standard documentation and effective records of all technical activities in dedicated worksheets (paper and/or electronic).
• Contribute in establishing Requests for Proposals for Process activities.

Profile

Experience

• Minimum of 5 years of experience in process development, engineering, technology transfer, scale-up and GMP clinical manufacturing of liquid sterile injectable drug products.
• Experience in long-acting injectables would be a plus.
• Previous engineering experience of a process development and transfer activities for injectable pharmaceutical products.

Qualifications

• Minimum of a Master’s degree in chemical engineering, process engineering and development or similar.
• Expertise in many manufacturing processes and equipment size from pilot to commercial scale.
• Knowledge of the critical activities and success factors required for an effective and efficient technology transfer.
• Knowledge of concepts, sequencing, and documentation of commissioning and qualification activities required by design intent.

Languages

• French and Fluent in English, spoken and written ability to attend complex meetings and write clear reports.

Additional skills

• Strong knowledge in regulatory requirements, pharmaceutical guidelines, and international standards, mainly in injectable products.
• Experienced in compounding raw materials and manufacturing drug products.
• Results orientation with focus on timely delivery and sense of urgency.
• Ability to make choices within budget and priorities.
• High degree of autonomy.