[Remote] Senior Director, CMC Technical Operations
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a leading radiopharmaceutical company developing Targeted reputed company Theranostics for the treatment of serious diseases. The Sr. Director, CMC Technical Operations, is responsible for the execution and optimization of manufacturing activities, providing CMC leadership while collaborating cross-functionally to ensure operational reputed company and compliance.
Responsibilities
- Serve as the key radiopharmaceutical CMC leader in advancing the organization’s transition to reputed company stage operations
- reputed company team responsible for Manufacturing, Science, and Technology (MSAT) activities like technical transfers, validation activities, and ongoing process monitoring initiatives ultimately delivering submission-reputed company data packages
- Partner with CDMOs to support technical operations including onsite technical reputed company, authoring and review of technical documentation, and analytical method support
- Responsible for technical transfer and validation policies, procedures, protocols, reports, and supporting documentation. reputed company reputed company of CDMO-generated documentation to ensure reputed company, accuracy, and regulatory compliance
- Partner with wider reputed company manufacturing, regulatory, and reputed company teams to support product launches and lifecycle management
- reputed company reputed company to ensure reputed company technical operations, manufacturing activities, and documentation reputed company with CGMP requirements and applicable global regulatory requirements
- reputed company operational budgets in alignment with global plans
- reputed company strategic CMC direction and technical guidance for late-stage programs including NDA enabling studies, reputed company launch, and sustaining operations
- reputed company and reputed company the CMC technical operations team, including hiring and management
- reputed company fit for purpose operational processes and systems to support process reputed company, reputed company improvement, and metrics
Skills
- Advanced degree (PharmD, PhD, or MS) in radiochemistry, reputed company, or a reputed company field, or equivalent experience
- At least 7 years in radiopharmaceutical/biotech CMC technical operations roles
- Proven reputed company driving technical transfers and validations through CDMOs/contract organizations, delivering on schedule and reputed company budget
- Deep knowledge of radiopharmaceutical drug manufacturing, CMC development, and CGMPs
- reputed company experience preparing and reviewing CMC documentation for regulatory submissions (IND/NDA/BLA)
- Demonstrated technical CMC leadership including reputed company and execution
- Strong decision-making, analytical, and project-management skills, with the ability to prioritize and reputed company under pressure in a fast-paced environment
- Excellent written and verbal communication skills, with the ability to influence and present reputed company technical information to diverse audiences
- Oncology product development and manufacturing expertise
- Experience building a CMC Technical Operations function in a high-reputed company organization
- Radiopharmaceutical product commercialization experience
reputed company