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Manager/Senior Manager CMC, Manufacturing and Supply

Open Position

Manager/Senior Manager CMC, Manufacturing and Supply

Job Summary

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
    submissions.

Job Details

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
    management.
  • 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
    recommend/implement solutions.
  • Manage drug product stability programs to support shelf-life and shipping stability
    management.
  • 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,
    protocols etc.
  • Document control – organize and manage the various documents associated with the
    projects, including CofA’s, protocols, batch records, analytical methods, and
    development reports.
  • 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.

Candidate Requirements

  • 8-10 years of drug product process development and manufacturing experience, including support of late-stage clinical development programs.
  • Knowledge of cGXP (GMP, GLP, GCP etc.) and quality systems.
  • Extensive CMC strategy and module 3 authorship experience.
  • CMO management experience.
  • Education – BS in Chemistry, Pharmaceutical sciences, or a related discipline
  • Operate with the utmost ethics and discretion, earning trust with peers, team, and
    entire staff.
  • Superior communications skills including written, verbal, and presentation skills.

To Apply

Please send your resume and message to tommcqueeney@elevartherapeutics.com.