CMC Specialist

Proclinical is seeking a dedicated CMC Specialist to join our client's team for a permanent role. In this role, you will be instrumental in the development and manufacturing processes of bispecific antibody leads, contributing to innovative cancer treatments. Your expertise will support both early and late-stage development activities, ensuring compliance with regulatory standards and good scientific practices.

Responsibilities:

• Provide scientific and technical input for CMC development plans and reports.
• Ensure process development and manufacturing align with regulatory guidelines and GMP, GLP, GDP standards.
• Prepare and review technical documents, including protocols and reports.
• Evaluate change controls and deviations in CMC activities.
• Participate in cross-functional subteams.
• Offer expertise on manufacturing, scale-up considerations, and GMP operations.
• Support regulatory submissions with input and review.
• Proactively report on the status and planning of CMC activities.

Key Skills and Requirements:

• Master's degree in a relevant biomedical field.
• Experience in CMC within the biotech or pharma industry.
• Familiarity with antibody development and manufacturing processes.
• Understanding of quality systems such as GMP, GLP, and GDP.
• Strong organizational skills and attention to detail.
• Effective communication skills in English, both verbal and written.

If you are having difficulty in applying or if you have any questions, please contact Ruhee Saleh at r.saleh@proclinical.com.

Apply Now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.