Your mission
We are seeking a CMC Technology Transfer Specialist (m/f/d) to lead the implementation of the drug product manufacturing process and technology at clinical trial locations. In this role, you will be responsible for ensuring that investigational products are successfully introduced and integrated into clinical environments. You will coordinate the preparation of all necessary technical documentation and facilitate knowledge transfer. Your focus will be on enabling the seamless adoption of new processes and technologies at hospitals and other clinical facilities, ensuring compliance with regulatory and quality standards throughout the technology transfer process.
Key Responsibilities:
Support cross-functional teams to ensure all requirements are fulfilled before transferring processes to clinical trial sites.
Prepare and maintain documentation, including technology transfer packages, validation plans, risk assessments, and technical reports.
Oversee clinical site set-up and validation activities, ensuring protocols and reports meet regulatory and quality expectations and project timelines.
Play a key role in coordinating interactions with third-party CDMOs to support outsourced activities.
Manage quality-related activities (e.g. deviations, change controls, self-inspections) in line with internal policies and regulatory standards.
Assist in resolving manufacturing and analytical issues encountered at clinical trial sites.
Coordinate with internal teams and clinical site partners to align deliverables and timelines.
