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CMC Operations Manager

Company Summary

Annexon Biosciences is a clinical-stage biopharmaceutical company developing a pipeline of novel therapies for patients with classical complement-mediated disorders of the body, brain and eye. The Company’s pipeline is based on its platform technology addressing well-researched classical complement-mediated autoimmune and neurodegenerative disease processes, both of which are triggered by aberrant activation of C1q, the initiating molecule of the classical complement pathway. The Company’s first product candidate, ANX005, is a full-length monoclonal antibody formulated for intravenous administration in autoimmune and neurodegenerative disorders. The Company’s second product candidate, ANX007, is a monoclonal antibody antigen-binding fragment (Fab) formulated for intravitreal administration for the treatment of neurodegenerative ophthalmic disorders. Based on learnings from its initial trials, Annexon is advancing its current programs while evaluating additional orphan and large market indications. Annexon is deploying a disciplined, biomarker-driven development strategy designed to establish that each of its product candidates is engaging the specific target at a well-tolerated therapeutic dose in the intended patient tissue.

Specific Responsibilities

  • Manage CMC material resource allocation and planning to support project deliverables including coordinating shipments and import/export activities.
  • Assist with development and management integrated CMC timelines for Contract Manufacturing partners (CMOs) and internal CMC and QA teams for clinical product development, analytical development, and release of clinical batches.
  • Coordinate with Clinical Operations and Project Management to ensure up-to-date information on clinical study design, clinical study enrollment rate and timeline are available to support drug inventory planning and tracking across different projects.
  • Coordinate and facilitate CMC Team meetings and CMO meetings (regularly scheduled and ad hoc) by providing meeting agendas, minutes, and tracking action items.
  • Partner with Portfolio team to leverage Project Management tools and templates where applicable.
  • Develop and provide consistent project tracking and project reporting to CMC leadership and project teams.
  • Ownership of departmental budget development for CMC projects. Own and track purchase-to-pay activities to make sure project budget goals are met.
  • Act as a liaison between CMC, CMO, and Legal groups to facilitate review and execution of contracts and business documents, including Master Service Agreement, Statement of Work, Change Order, and Confidentiality Disclosure Agreement.

Key Qualifications

  • Undergraduate degree in a scientific, medical or business discipline; postgraduate qualifications (e.g., Ph.D., MBA, MS) or commensurate experience is a plus
  • Minimum 7 years’ pharmaceutical industry experience with some past experience with CMC
  • CMO/CRO management experience is desirable
  • Exceptional communication and organizational skills
  • Demonstrated ability to prioritize and plan realistic deadlines
  • Team-oriented, with excellent interpersonal skills (i.e. adaptable, flexible, collaborative).
  • Fluent in project management tools such as Excel, Project, and Smartsheet is required

Annexon is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.