GE HealthCare in Oslo is looking for a Lead Scientist Pharmaceutical Development

The Lead Scientist, Pharmaceutical Development will join the Pharmaceutical Development department which is scientifically responsible for defining, developing and delivering formulations and materials for diagnostic imaging products. The Pharmaceutical Development team is part of Pharmaceutical Diagnostics R&D, GE HealthCare. Key business areas are neurology, oncology and cardiology, where GE HealthCare provides contrast agents and molecular imaging products across the imaging modalities MRI, X-Ray, Ultrasound, SPECT and PET. The products span across simple solutions, gas bubbles, cassette-based products and freeze-dried formulations. The drug products are for i.v. injection, so sterility assurance and adequate microbiological controls of all materials is a critical part of the development work.

To join our team, we are looking for a highly motivated and creative scientist. The position offers an exciting opportunity to be part of a dynamic team. As a Lead Scientist in Pharmaceutical Development you will get an operational role within the R&D organization. The work will often take place in a laboratory setting and is largely focused on experimentation. To have impact on our project portfolio, you need to demonstrate curiosity, broad and deep technical skill set, collaborative mindset, excellent influencing and team building skills.

Essential Responsibilities

• As part of a multifunctional team, have responsibility for 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.
• Design and develop suitable formulations and production processes of new product candidates to correct level of quality, specifications and controls. This includes definition of quality target product profile and critical quality attributes.
• 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.
• Supply of drug product to pre-clinical and clinical studies.
• Provide drug product development expertise to support R&D projects in development and post marketing.
• Work closely with external partners incl. project management of any work outsourced to external parties.
• Supervise/ mentor other staff as required.
• Participate in Operational Excellence and Lean projects.
• Produce and review suitable scientific reports & documentation to support regulatory documentation packages (IND, IMPD, NDA, MAA, etc).
• Write development sections of regulatory submissions according to relevant guidelines.

Further, the candidate should have a problem solving mindset and be capable to develop own risk mitigation strategies.

Qualifications/Requirements

• Master of Science or PhD in Pharmaceutics, Pharmaceutical Chemistry, Biotechnology, Bioengineering, or in a related discipline with relevant industry experience.
• Strong knowledge and hands-on expertise from formulation development of drug product.
• 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 or Regulatory Body.
• 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.