As a CMC Process Development Specialist (m/f/d), you will play a crucial role in developing and validating manufacturing processes and reagent kits. Your focus will be on ensuring these processes are robust, scalable, and compliant with regulatory requirements. You will work closely with cross-functional teams and oversee partnerships with Contract Development & Manufacturing Organisations (CDMOs) to optimise workflows, facilitate technology transfer, and maintain high-quality standards. Additionally, you will prepare and review CMC documentation to support regulatory submissions.

Key Responsibilities:

CDMO & Process Development:

• Manage the scale-up and optimisation of manufacturing workflows to meet clinical and regulatory requirements.

• Oversee and coordinate CDMO partnerships, ensuring efficient development, validation, and technology transfer of manufacturing processes.

• Evaluate and monitor third-party performance to maintain compliance with regulatory and quality standards.

Collaboration & Technical Support:

• Work cross-functionally with R&D, product development, and quality assurance teams to enhance process efficiency and ensure regulatory compliance.

• Provide technical expertise in process development, impurity analysis, toxicology studies and quality control.

• Support troubleshooting and resolution of manufacturing and analytical challenges.

Documentation & Compliance:

• Prepare, review, and maintain CMC-related documents, including reports, protocols, SOPs, and eCTD modules.

• Ensure accurate and complete documentation of process development activities for regulatory submissions.

• Adhere to GMP, GLP, and ICH guidelines while ensuring data integrity and compliance with global regulatory standards.