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CMC Lead
2 months ago
MEDIPOST America, Inc. is seeking a highly skilled CMC Lead to join our team. As a key member of our organization, you will be responsible for leading tech transfer to our late-phase and commercial CDMO, managing DP production for our Phase III trials, preparing the CMC strategy for BLA submission, and building a manufacturing organization for commercialization.
Key Responsibilities:- Lead tech transfer to our CDMO and ensure seamless integration of processes.
- Manage DP production for Phase III trials and ensure compliance with regulatory requirements.
- Develop and execute CMC strategy for BLA submission and ensure timely delivery.
- Build a manufacturing organization for commercialization and ensure scalability.
- Partner with departmental leaders in CMC, Clinical Development, and Regulatory departments to achieve program objectives.
- Bachelor's degree in science, engineering, or related discipline; advanced degree (MS, PharmD, or PhD) preferred.
- Advanced knowledge and experience in CMC Drug Development for Cell & Gene Therapy.
- Hands-on knowledge of cGMP and CMC regulatory requirements for cell or gene therapy manufacturing.
- Six-sigma qualified with experience in QbD and DoE preferred.
- 10+ years of post-graduate experience leading CMC projects, with at least 5 years in cell therapy manufacturing preferred.
- Demonstrated leadership in managing teams, projects, and budgets.
- Experience in late-stage clinical programs, BLA submissions, and commercial manufacturing preferred.
- Experience with drug-device combination products preferred.
- Previous experience with CGT CDMOs is a plus.
- Excellent interpersonal and communication skills.
- Strong organizational skills and ability to work in a multicultural environment.
- Ability to motivate teams and deliver on milestones.
- Strong analytical and problem-solving skills.
- Proven success in goal setting, resource planning, and budget management.
- Flexibility and comfort with ambiguity.
- Travel Requirements:25% to 40% travel as needed.
MEDIPOST America, Inc. is a leading cell therapy company dedicated to revolutionizing healthcare through cutting-edge solutions. As a CMC Lead, you will play a pivotal role in shaping our organization's future and contributing to the development of innovative therapies.
