Device & Combination Product Development Expert
Our client is a public Swiss Specialty Pharma company listed on the SIX Swiss Stock Exchange focusing on the discovery and development of macrocycle drugs addressing high unmet medical needs. These macrocycles represent a new drug class complementary to the classical small molecules and large biopharmaceuticals. They are currently looking for a Device & Combination Product Development Expert
- Accountable and responsible for technical product development from concept to market launch to meet business objectives.
- Provide sound technical & engineering expertise to develop new product and timely address technical resolution for devices, combination product and packaging, and ensure end to end robustness of developed products.
- Execute all Design Development and Engineering activities & tasks defined for the product including GMP technical documentation management, support to Regulatory filings and maintaining inspection readiness.
- Design Product & Lead technical activities internally, with suppliers and service providers
- Responsible for the development, implementation and validation of all test methods required to effectively characterize products.
- Effectively collaborate with all project functions and communicate technical equipment requirement for industrialization of the product.
- Maintain an overview of state-of-the-art technology development within the related business, and Participate in the evaluation and assessment of products, processes and suppliers for new product
- Ensure compliance with all local, state, federal, and internal company quality policies, procedures and practices, safety regulations, policies, and procedures.
Qualifications and Experience:
- Undergraduate degree in related engineering field, advanced degree desired.
- Minimum 7 years of experience in engineering/technical field, with 5 years demonstrated product development in medical or pharmaceutical industry with successful track record of delivering products to market.
- Demonstrated medical device, combination product and packaging development technical skills.
- Sound statistical knowledge and associated system (e.g. minitab).
- Broad and deep understanding of disciplined product development processes, regulatory, and quality requirements.
- Ability to use Computer Aided Design (CAD) system. (e.g SolidWorks…)
- Strong skills in project planning and management
- Experience in leading a team
- Fluency in English
- Relevant working/residency permit or Swiss/EU-Citizenship required