Senior Research Associate
Stagiaire Science Talents
Description de l'emploi
- Set up and perform studies to test ideas for new pharmaceutical and device solution till the registration studies to support New Drug Application.
- Design appropriate experiments to solve technical problems and to lower proactively project – risks.
- Organize and provide technical leadership in the areas of CMC development and review, formulation development, analytical methods development and validation, preclinical activities, and manufacturing process validations. Set up studies to generate the necessary results. Review the experimental data and validate the results. Report and present the results.
- Develop, validate and perform chemical analysis methods on a variety of samples. Perform critical review of data obtained and issue reports
- Lead multifunctional project teams for the development of new products. Planning of development activities. Develop effective project milestones and schedules.
- Lead the life cycle management activities, including product/process change control, risk management activities.
- Work with manufacturing partners to transfer activities and solve problems.
- Collaborate with Universities, Partners or hospital to generate new ideas or support the development of new solutions. (not frequently)
- Ensure IP protection or freedom to operate.
- Review the literatures and all guidelines on frequent base.
- Maintain current knowledge of relevant Quality System Regulations and other regulatory requirements related to research and development (product development, design and safety) to ensure compliance in all research, data collection and reporting activities.
- Actively participate and support required QMS activities, including complaint and pharmacovigilance reporting
- Master or phd: physiology, biochemistry, biology, chemistry
- Minimum 4 years experience
- Experience in Project Management
- Statistical software knowledge
- Good knowledge of the requirements of pharmaceutical and medical device development (ICH guidelines, EN ISO13485, MDD 93/42/EEC, GMP).
- Experience designing and implementing technical studies.
- Demonstrated technical writing proficiency/authoring internal reports and scientific papers.
- Experience conducting database research for the acquisition of desired information.
- Ability/experience interpreting results from complex instrumentation and scientific studies.
- Ability to establish clear lines of communication to key stakeholders for favorable outcome of projects.
- Languages: English