Essential Responsibilities
- As part of a multifunctional team, contribute to the development of new imaging products for pre-clinical and clinical use and into commercial manufacturing, including formulation development, drug product process development and scale-up, technology transfer and GMP manufacture support.
- Prepare suitable formulations and production processes of new product candidates to correct level of quality, specifications and controls.
- In charge of laboratory work within defined area incl. planning and execution of experimental work to ensure projects are completed to agreed time and resource level.
- Work closely with external partners of any work outsourced.
- Supervise/ mentor other staff as required.
- Participate in Operational Excellence and Lean projects.
- Communicate experimental findings either verbally or in appropriate documents in a clear and concise manner.
- Produce and review suitable scientific reports & documentation to support regulatory documentation packages (IND, IMPD, NDA, MAA, etc).
Qualifications/Requirements
- Master of Science in Pharmaceutics, Pharmaceutical Chemistry, Biotechnology, Bioengineering, or in a related discipline with relevant industry experience.
- Ability to design and develop new pharmaceutical formulations and manufacturing processes drawing on multidisciplinary input on physical, chemical, biological, and engineering sciences.
- Strong scientific capability and clear thinking.
- Entrepreneurial mindset and good problem-solving skills as well as ability to adapt to changing priorities.
- Ability to breakdown complex problems into achievable goals and provide effective solutions.
- Capability of applying appropriate statistical planning and analysis tools as part of formulation development.
- Self-motivated and ability to work independently and as part of a team.
- Excellent team working skills and working with people across cultures.
- Ability to handle multiple tasks.
- Strong oral and written communication skills.
- English fluent verbal and written, and preferably Norwegian
Desired Characteristics/Skills
- Professional experience from Pharmaceutical Industry.
- In-depth understanding of GMP and regulatory requirements during the drug product development phases.
- Has developed and continues to build wide and effective networks of contacts.
- Experience in lyophilization cycle development.
- Experienced in using statistical data analysis and modelling.