Job Description Summary
As a CMC development specialist, strengthen Japan’s CMC development strategy by providing scientific and technical support to global and local CMC development teams and related functions, while staying current with emerging technologies.

Job Description
Major Accountabilities
1. Serve as a CMC Subject Matter Expert (SME) within the submission team from clinical trial initiation through NDA filing.

Understand CMC development strategies for assigned projects and advise on potential risks, particularly regarding novel or complex scientific and technical areas.
Research and develop expertise in various modalities (e.g., small molecules, nucleic acids, radioligands, biologics, cell & gene therapies) and supporting technologies (e.g., formulations, process development, manufacturing and control strategies), providing expert consultation as needed.
Provide input on Japan-specific analytical requirements, address issues through scientific/technical discussions with global and local stakeholders, and review/prepare documents and protocols necessary for Japan (e.g., test methods, validation reports, stability studies, compatibility studies).
Review Japan NDA documents such as Module 3 and quality summaries.

2. Act as a CMC expert supporting other functional areas beyond the submission team.

Stay informed on new analytical/manufacturing technologies, new modalities, and regulatory updates, and share insights to enhance organizational capabilities.
Contribute to data generation for marketed products (e.g., special-condition stability, compatibility studies) in collaboration with global teams.
Provide technical information to commercial-related divisions as needed.
Collaborate with clinical teams to support accelerated clinical development in Japan from a CMC perspective.
Respond to additional requests from functions outside the development team.

3. Maintain SOPs and development manuals.

Provide input on Japan-specific requirements for global development SOPs and manuals.
Develop and maintain Japan-local SOPs and related documents.

4. Act as QC function for investigational medicinal product (IMP) release in Japan.

Execute release procedures and manage retain samples in accordance with SOPs and applicable regulations.

5. Ensure compliance with internal requirements.

Ensure accurate reporting of adverse events, technical complaints, and compliance issues per company procedures.
Complete all required training within designated timelines.

6. Serve as a manager.

Mentor and train associates to build capability within the organization.
Lead various activities within the local development function.