Scientist - CMC Development

Precirix

Brussels, Belgium

Purpose of the Position:

Precirix is seeking a Scientist – CMC Development to strengthen the radiochemical activities dedicated to the evaluation and clinical translation of radiopharmaceuticals. The ideal candidate will be responsible for analytical method and manufacturing process development and has relevant experience in this domain.

Key Responsibilities

Lead in the development of manufacturing processes for radiopharmaceuticals for eventual clinical intent;
Lead the development of quality control methods for testing of radiopharmaceuticals;
Participate in the technology transfer of production and quality control methods to CDMOs;
Contribute to on-site training of operators at CDMOs as part of technology transfer activities;
Participate in drafting protocols, methods, technology transfer documents, and regulatory document sections;
Contribute to the development of new methodologies for radiolabeling of compounds;
Report about the progress and conclusion of work packages and discusses the outcome in dedicated meetings.

Key Qualifications

University degree in (radio-) chemistry. Experience in the radiopharmaceutical industry is a bonus;
Knowledge of cGMP and ICH/FDA guidelines is an asset;
Experience in interacting with CDMOs is an added value;
Willingness to travel;
Works independently within the scope of his/her assigned field and supports others;
Is self-organized and has good organizational skills;
Good communication skills;
Can deal with significant responsibilities and is stress-resistant;
Ability to interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals;
Good computer skills.

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