Department: Product Development/CMC

Chemistry, Manufacturing & Controls (CMC) Project Manager

Summary:

The CMC Project Manager has an overall understanding of CMC function, with responsibility for managing key activities across CMC disciplines. Working with internal project teams spanning early to late stage development, registration, and commercialization, and external partners including CMOs and CROs, this individual will help define deliverables and manage assigned CMC related activities, with emphasis on manufacturing, testing and distribution of investigational drug product.

Position description:

  • Coordinate CMC activities and team meetings with CMOs or other external partners (regularly scheduled and ad hoc) by planning meeting agendas, providing minutes, and ensuring action items are assigned and completed.
  • Develop and manage integrated CMC timelines for TB Alliance, Contract Manufacturing partners (CMOs), and internal teams for clinical product development, analytical development, and release of clinical batches.
  • Plan and manage CMC drug substance and drug product inventory and allocation to support project deliverables including coordinating shipments and import/export activities.
  • Coordinate with Clinical Supply Manager to support planning and packaging of clinical trial material.
  • Assist with establishing master contracts and work orders for CMC activity and serve as departmental point of contact for securing internal review and approvals.  Manage day-to-day activities in accordance with contractual commitments.
  • Contribute to budget development, forecasting, and expense management for all CMC projects and, with assistance from project coordinator, review and track invoicing/payments to make sure project budget goals are met.
  • Develop and provide consistent project tracking and project reporting to CMC Senior Management and project teams.
  • Coordinate with the preclinical project manager to support and ensure timely and efficient delivery of Active Pharmaceutical Ingredients (API).

Ideal candidates will have:

  • This position requires a broad-based CMC specialist, ideally with experience working in a highly outsourced operating environment.
  • 5 -7 years project management experience within pharmaceutical industry, with emphasis on pharmaceutical sciences, CMC, product development, related regulatory requirements, and supply chain management.
  • Experience managing external relationships with CMO and CRO partners, including supply chain coordination is preferred.  Ideally, experience will span all stages of development, registration, and commercialization.
  • Bachelor’s degree in a life sciences discipline or engineering. Advanced degree in a relevant discipline preferred
  • Exceptional oral and written communication skills
  • Demonstrated critical thinking skills, decision making and problem-solving skills, coupled with the ability to operate autonomously under general direction.
  • Strong attention to detail and ability to adapt to evolving priorities.
  • Proficiency using Microsoft Office products, including Microsoft Project
  • Ability to travel up to 10%

Location:

New York, NY

Organizational Information:

TB Alliance is a not-for-profit organization dedicated to the discovery and development of better, faster, affordable tuberculosis drugs that are available to those who need them.Through innovative science and with partners around the globe, we lead a global effort to ensure development of and equitable access to faster, better tuberculosis cures that will advance global health and prosperity.

With an annual operating budget of approximately $60 million, the TB Alliance leads the advancement of the most comprehensive R&D portfolio of TB drug candidates in history. Additionally, the TB Alliance drives efforts to ensure regulatory approval, country adoption of new regimens, and widespread availability of new drug regimens to patients. For more information, please access the website: www.tballiance.org.

Our Pipeline

TB Alliance manages the largest pipeline of new TB drugs in history.

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