Senior Scientist Cmc

il y a 19 heures

Gent, Belgique MindCapture Temps plein

SENIOR SCIENTIST CMC
- Biotechnology- GhentWHAT IS OFFERED
- Competitive salary package with extensive benefits.
- Opportunity to contribute to the development of therapeutic antibodies and make a tangible impact on patient care.
- Dynamic work environment within a rapidly growing biotech company.
- Collaborative culture that fosters creativity, innovation and teamwork.
- Access to state-of-the-art facilities and cutting-edge technologies.
- Flexible work arrangements and a healthy work-life balance.
- Recognition and rewards programs to celebrate achievements and contributions.

ABOUT THE COMPANY

Our client is a leading biopharmaceutical company focused on the advancement of novel therapeutic solutions. With a commitment to innovation and a dedication to improving patient outcomes, our client utilises cutting-edge technologies and a talented team to develop a diverse pipeline of antibody-based treatments.

We are seeking an experienced and motivated Senior Scientist to join our client’s CMC team. In this role, you will play a lead role in supporting cell line development, drug substance manufacturing process development, and analytical method development with external manufacturing partners (CMOs) to enable clinical manufacture of our client’s therapeutic antibodies.

Key responsibilities include:

- Providing oversight of cell line and process (USP and DSP) development track at CDMO and offering expert input.
- Technical review of CMC documentation and batch manufacturing records, with the ability to draw appropriate conclusions.
- Actively supporting the internal development of analytical methods (chromatography, bioassays, etc.).
- Identifying project critical path items, risks, and gaps, and formulating corrective actions.
- Contributing to technical and strategic discussions as a member of the CMC (Early Development) team.
- Updating project dashboards/presentations with project status to ensure timely communication.

REQUIRED COMPETENCES & SKILLS
- Masters/PhD in chemistry, pharmaceutical sciences, bio-engineering, or related discipline within pharmaceutical/biotechnology sciences.
- Ability to lead tech transfer activities, with previous experience in this area desired.
- Strong technical expertise in biological development, drug substance manufacturing, and product/process characterisation.
- Proficiency in analytical methods such as chromatography and bioassays.
- Minimum of 3 years of experience within the relevant industry.
- Hands-on experience in chromatography, viral inactivation, virus filtration, and UF/DF operations desired.
- Strong problem-solving skills and critical thinking ability.
- Excellent organisational and coordination skills, with attention to detail.
- Effective communication skills with internal and external stakeholders.
- Flexibility to balance multiple priorities in a fast-paced environment.
- Knowledge of ICH and GMP regulations.
- Ability to work independently and keep abreast of relevant scientific/technical developments.

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