Manager/Senior Manager CMC, Manufacturing and Supply
The manager/senior manager will manage and support technical operations including but not limited to, clinical and commercial manufacturing, process development and control, process validation, technology transfer, CMC support of regulatory filings and CMO management. This position will be responsible for supporting Elevar’s leadership to advance drug product manufacturing programs.
- Manage Contract Manufacturing Organization (CMO) activities with respect to manufacturing of clinical and commercial validation batches.
- Ensure there is no disruption in the Clinical Trial Materials (CTMs) supply for ongoing clinical trials.
- Manage CMO activities with respect to drug product validation and commercial
batches and product launch activities.
- Manage CMC product development activities such as product trade dress, product
identification, packaging presentation, etc.
- Prepare and review the drug product CMC sections in a timely manner for the IND and NDA
Functions associated with this position include but not limited to:
- Manage contract manufacturing, process validation, packaging, labeling, and testing
operations for clinical and commercial drug products.
- Manage contractors and third-party vendors to ensure products meet quality
requirements and timelines.
- Build and manage program timelines across CMOs and partners for communication to
- Review and approve drug product manufacturing batch records, protocols, deviation reports for all CMC activities including manufacturing, product release testing, stability program, packaging, and labeling.
- Manage production plans to support, pre-clinical, clinical, and commercial programs. o Proactively identify potential manufacturing and quality issues/risks and
- Manage drug product stability programs to support shelf-life and shipping stability
- Participate in and facilitate CMC/Vendor selection process for outsourced activities,
including RFP generation.
- Internal document drafting of consolidated reports, technical transfer protocols,
stability assessments etc.
- Document review, including: Executed GMP batch records, shipping documents,
- Document control – organize and manage the various documents associated with the
projects, including CofA’s, protocols, batch records, analytical methods, and
- Assemble/author module 3 CTD to support regulatory submissions.
- This position will work with members of the CMC, QC, regulatory, and external partners
to ensure Elevar achieves its development milestones.