On behalf of Nordic Nanovector ASA we are looking for a Radiopharmaceutical Expert who will be responsible for the development of the Betalutin drug product for use in clinical trials, as well as developing Betalutin manufacturing for the commercial phase. The position is an opportunity to join an innovative company in the pharmaceutical industry which works towards new and promising cancer treatments. The Radiopharmaceutical Expert will be part of a diverse, dedicated and highly experienced CMC team.
Key responsibilities
- Coordinate project related activities for development and manufacture of Betalutin
- Manage/participate in all Chemistry, Manufacturing and Control (CMC) development activities related to the company's radiopharmaceutical products, including process development, characterisation and validation activities
- Close oversight of CMO's and CRO's performance to ensure the efficient, good quality and cost-effective supply of Betalutin drug product globally
- Preparation of original protocols, reports or other forms of summary descriptions of relevant scientific and technical information in line with instructions and regulatory authority requirements
- Participates in the development and implementation of International CMC Regulatory strategies
- Responsible for scientific development for the radiopharmaceutical products in accordance with the company's strategy and project plans
- Responsible for relevant CMC sections of INDs, NDAs, BLAs, CTAs, IMPDs and MAs for Betalutin and other radiopharmaceutical products in development
- Following up current regulatory guidelines and requirements in relevant areas, like Europe, US and other regions
- Contribute to the company's strategic research and development roadmap and activities in support of the portfolio strategy
- Lead team for technology transfer to CMOs and CROs when required.
- Serve as the CMC radiopharmaceutical representative in the technical development team
What we are looking for
- PhD or Master's degree with 5+ years postgraduate experience in biotech/biopharma industry in the development and manufacturing of radiopharmaceuticals
- Experience in the preparation of original protocols and technical reports
- Experience in management of CMOs and CROs
- Experience in process validation for radiopharmaceuticals
- Experience in tech transfer of manufacturing/QC processes between CMOs organizations
- Strong technical skills in manufacturing process development for the company's radiopharmaceutical products
- Excellent communication skills, with a high proficiency in English in addition to good Norwegian language skills
Reporting line, location and compensation.
The position reports to the Director Radiopharmaceutical Production and is based at the company's headquarters in Oslo, Norway. Nordic Nanovector offers a challenging and exciting role in one of Norway's most innovative pharmaceutical companies. Level of compensation will reflect experience and qualifications.
For further information about this position please contact our recruitment partner at Kelly Science: Branch Manager Thomas Lund, +47 815 00 044 or Consultant Jacquelyn Diamond +47 969 07 226.
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