Project Manager – CMC

Posted 5 September

   CMC   ·   Drug Development    ·  Biotech

The company

Our client, a Melbourne based biotechnology company, has developed a unique world leading platform technology that enables site specific drug delivery. Their technology involves development of patented polymeric prodrugs that can be engineered into various product forms.  Now is an exciting time, as they move to a brand-new facility in Notting Hill.

 

The role

Reporting to the Head of Product Development & Technical Affairs, the CMC Project Manager is a new role due to growth. Your key remit will be to will assist with managing the planning and on-time completion of product development activities, from discovery through to NDA submission and approval.

  • Develop and document project plans, actions, and project status updates.
  • Facilitate planning of CMC activities across drug substance, drug product and clinical supply chain to align dependencies, schedules, and delivery commitments, including the provision of logistics and supply chain management support.
  • Support the optimisation of CMC project deliverables including schedules, resources, budgets.
  • Create, manage, and facilitate regular meetings, including the development of agendas, issue written minutes, and follow up on actionable items.
  • Proactively communicate key issues and any other critical topics in a timely manner.
  • Maintain an organised system of records and key manufacturing documents to support future regulatory submissions.
  • Support writing, review, publication, and filing of CMC-related regulatory documents including those associated with INDs and product registration submissions.
  • Prepare requests for proposals and make recommendations on CMO and supplier selections.

 

Expertise required

  • Degree Qualification Science / Chemistry discipline.
  • At least three years of relevant pharmaceutical industry experience.
  • A demonstrated ability and experience in project management.
  • Experience with pharmaceutical product development, and preferably CMC.
  • Planning, budgeting, organizing, and managing multiple priorities simultaneously.
  • Knowledge of regulatory standards applicable to drug substance and drug products.
  • Experience working within a quality environment, ideally in the development of polymeric prodrugs.
  • Excellent verbal and written communication skills and strong technical document writing skills
  • Involvement with preparation of regulatory documentation to support an IND filing is desirable.

 

The application

Organised and  proactive, you are a candidate that thrives on ensuring projects are completed on time with a high attention to detail. This role is at the frontline of the development of new innovative technologies. You may be currently in a similar role or aspire to.

To join our client in this exciting opportunity, please email your cover letter & CV to careers@mexec.com. Confidential enquiries to Marilyn Jones on 1300 0 MEXEC

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