Senior Process Development Engineer

Medincell
is a commercial-stage pharmaceutical company developing long-acting injectable drugs in many therapeutic areas. Products of our portfolio are based on our BEPO technology and aim to ensure patient compliance, improve the effectiveness and accessibility of treatments, and reduce their environmental footprint. We collaborate with tier one pharmaceuticals companies and foundations to improve Global Health through new therapeutic options.

We are looking for a
Senior 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 and Manufacturing

• Deploys 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.
• Foresees 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.
• Responsible for industrial engineering standards and application to capital investments, for facility and equipment utilization, and for operational efficiencies.
• Contributes and entables the engineering function to deliver from the design, conception and strategy implementation for both internal and external resources.

Pharmaceutical Development

• Ensures 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.
• Assures 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.
• Selects appropriate vendors for what regards management of equipment including maintenance.
• Ensures 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.
• Maintains updated knowledge of relevant guidelines and regulatory requirements in all phases of development.
• Maintains high standard documentation and effective records of all technical activities in dedicated worksheets (paper and/or electronic).
• Contributes in establishing Requests for Proposals for Process activities.

Experiences

• 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.

Medincell is an equal opportunity employer committed to fostering an inclusive and respectful workplace. We welcome applications from all backgrounds and believe that diversity strengthens our teams and drives innovation.