We are actively looking to recruit an Engineer to be part of the CMC (Chemistry/Manufacturing/Controls) department at TISSIUM. This person will be responsible to manage key microprojects and studies incorporated within the development and verification/validation of TISSIUM’s biodegradable polymers.
The CMC Engineer will report to the Head of CMC. The position is based in Paris, France with regular trips to our production facility in Lille.

DUTIES & RESPONSIBILITIES

• Set-up and manage activities linked to the development of TISSIUM’s polymers including process design and optimization, scale-up and transfer to production either internally or in collaboration with subcontractor.
• Perform experimental work needed to support the development of TISSIUM’s polymers.
• Plan and follow subcontracting activities including feasibility/optimization activities, production planification and batch reviews.
• Design, perform and follow key testing methods to support the safety and performance of TISSIUM’s polymers.
• Design, plan and follow key studies as part of verification and validation programs like stability studies and in vitro degradation studies.
• Contribute to Chemical characterization effort as part of preclinical activities to support the Toxicological Profile of TISSIUM’s polymers.
• Support the development team on writing/reviewing various CMC documentation to support the development of Tissium products;

ENVIRONMENT & INTERACTIONS

• Pro-actively work in close collaboration with other departments (Development, Research, Quality, Regulatory);
• Assist in the preparation of the Design Dossier documentation by working closely with the company’s product development team;
• Present results within reports and oral presentations to the other teams and Executive Committee.

QUALIFICATIONS & SKILLS

• Engineering degree or equivalent;
• At least 2-3 years of experience in development/manufacturing of medical products (pharma or medical devices);
• Strong background in Chemistry, process development and analytics. Expertise in polymers is a plus;
• Excellent understanding of quality requirements needed within a life science company (GMP, ISO 13485…).
• Excellent communication skills (written and verbal) in English.

COMPETENCIES & PERSONAL ATTRIBUTES

• Autonomy and great organization skills;
• Strong planning, problem solving, and negotiation skills;
• Strong ability in driving third parties to adhere to timelines and budgets;
• Excellent teamwork abilities;
• Ability to understand complicated processes and associated suppliers’ interactions;
• Creativity in approaching and solving technical challenges.