(Senior) Scientist Protein CMC

Contenido de trabajo

Precirix is a clinical-stage biotechnology company dedicated to improving the lives of cancer patients by developing novel targeted radiopharmaceuticals using camelid single domain antibody fragments. The company is advancing its lead product CAM-H2 through a Phase I/II clinical trial targeting HER2-positive tumors, while further progressing and broadening its oncology pipeline. PRECIRIX’ technology platform allows for a theranostic approach, using the same molecule for patient selection (imaging) and therapy.

For the expansion of our Protein CMC team based in Brussels, we are currently looking for an enthusiastic and talented Scientist to work in our brand new facilities.

Purpose of the Position

As (Senior) Scientist Protein CMC you will contribute to the development, manufacturing and characterization of camelid single domain antibody fragments (sdAbs) to feed the company’s clinical pipeline of targeted radionuclide cancer therapeutics.

You will manage internal and external projects that focus on process development and characterization for (clinical) sdAb manufacturing (strain development, USP, DSP, formulation). Also, you will participate in preparation of regulatory submissions to competent authorities, in close collaboration with the radiochemistry and clinical teams. Additionally, you will contribute to analytical assay development (IPC, QC) and sdAb characterization.

Key responsibilities

Scientific activities:

• Originate, plan and execute research activities within the scope of an assigned work package and timing.
• Manage collaborations with CROs and CDMOs, and support technology transfer for upscaling activities and (clinical) manufacturing
• Act as a subject matter expert in CMC aspects of protein manufacturing and characterization (science and methodology). Suggest new methodologies and approaches, and provide project support to other scientific teams within the company.
• Keep abreast with relevant scientific and/or technical developments. Search literature (incl. patents) independently and apply knowledge on the job
• Active in multiple, multi-disciplinary projects inside the company
• Independently interpret, document, retain and summarize experimental data and results in adequate systems (e.g. electronic lab notebooks and regulatory filings)

Communication:

• Report (written and orally) progress and conclusions of work packages to the project team
• Report and review experimental data and results during recurring R&D team meetings
• Ensure a clear communication with CROs and CMOs.
• Actively contribute to multi-disciplinary discussions between different scientific teams.
• Author and review development reports, study protocols, study reports, manufacturing batch records and SOPs.
• Author and review relevant sections of regulatory documents for submission to competent authorities (IMPD, IND, scientific advice briefing books).

Profile

• PhD or MSc with equivalent experience in a relevant field of life sciences (Bio-engineering sciences, Biochemistry, Biology, Biomedical sciences, Pharmaceutical sciences).
• At least 3 years of experience in CMC, regulatory submissions, and/or quality assurance
• A good understanding of process development, scale-up and GMP manufacturing of biologicals is a must
• Experience in quality control and characterization of antibodies is a plus
• Work independently within the scope of an assigned work package and eager to support others
• Attentive to details and quality-oriented.
• Thrives in a multi-disciplinary team environment.
• Self-organized and a team player
• Good written and oral communication skills
• Can deal with significant responsibilities and is stress-resistant

Our offer

• Full-time position in a dynamic, motivated and multi-disciplinary team that is fully devoted to the fight against cancer
• A state-of-the-art protein R&D lab located in Brussels
• An environment with nice colleagues that value a cooperative environment
• Possibility for homeworking 2 days a week
• Scale up company with entrepreneurial atmosphere
• Team with different nationalities working together towards the same goal
• Salary package according to your qualifications, hospitalization insurance, group insurance including pension savings (3% of the gross wage fully paid by employer), costs proper to employer according to level, meal vouchers, ecocheques, bonus. We are also open to work with a Consultancy Agreement.