Title: Manager/Sr Manager CMC, Manufacturing Clinical Supply
Location: 100% Remote
Company Summary: The company is a small, but rapidly growing, fully integrated company built on the promise of elevating treatment outcomes for patients who have limited therapeutic options. Their experience is rooted in oncology to identify and develop promising medicines for complex health conditions. This is an emerging company and that is getting ready for commercialization and is looking for a leader to come in and drive the department and be a part of the change. This is a great opportunity to help build a world class Clinical Supply function within a rapidly growing Pharma company..
The Manager/Sr Manager CMC, Manufacturing Clinical Supply
- Develp presentations for S&OP meetings with Commercial and Finance to align plans between Manage Cntract Manufacturing Organization (CMO) activities with respect to manufacturing of clinical and commercial validation batches.
- Ensure there is n disruption in the Clinical Trial Materials (CTMs) supply for ongoing clinical trials.
- Manage CMO activities with respect t drug product validation and commercial
- batches and prduct launch activities.
- Manage CMC prduct development activities such as product trade dress, product identification, packaging presentation, etc.
- Prepare and review the drug prduct CMC sections in a timely manner for the IND and NDA submissions.
The Manager/Sr Manager CMC, Manufacturing Clinical Supply should have the following qualifications:
- 8-10 years f drug product process development and manufacturing experience, including support of late-stage clinical development programs.
- Knwledge of cGXP (GMP, GLP, GCP etc.) and quality systems.
- Extensive CMC strategy and mdule 3 authorship experience.
- CMO management experience.
- Health Insurance
- FREE Medical Insurance