Fusion Pharmaceuticals
  • Hamilton/ Boston, USA, ON, CAN
  • Full Time

 

Fusion Pharmaceuticals is a newly formed biopharmaceutical company discovering and developing targeted alpha-particle radiotherapeutics for treating cancer.  Targeted alpha-particle emitting radiotherapeutics combine the precision of molecular targeting agents, such as antibodies, with the potency of alpha-particle emitting radioisotopes to specifically attack and eradicate cancer cells.

The newly created position of Director, Pharmaceutical Operations reports to the Chief Scientific Officer and is a key cross-functional position in the organization with influence and responsibility across many of the company's activities.  This position will be responsible for biologics process development and manufacturing for all of the company's programs.  In addition, the incumbent will be responsible for managing the company's complex and diverse supply chain.  The successful candidate must be self-motivated, highly organized, and an excellent communicator.

Responsibilities:

  • Oversee process development, technology transfer, and CMO-based cGMP manufacturing of monoclonal antibodies and small proteins
  • Manage projects and logistics of outsourced development and manufacturing activities at CMOs
  • Use sound scientific and engineering criteria to design and develop manufacturing processes, identify and execute process improvement/ optimization strategies, and ensure successful scale-up and technology transfer of biologic products
  • Identify appropriate CMOs, complete contract(s), and manage technology transfer to support scale-up and cGMP manufacturing
  • Serve as Person-in-Plant (PIP) in manufacturing campaigns, as necessary
  • Support discovery team by leading manufacturability assessments of preclinical material
  • Establish and oversee external radiopharmaceutical manufacturing supply chain for all clinical programs
  • Support regulatory interactions and contribute to content of regulatory documents (IND, briefing packages) as needed
  • Laisse with Clinical and Preclinical departments to ensure on-time supply of Drug Product for all development studies
  • All other tasks that support the core objectives as assigned

Qualifications and Experience

  • PhD in biochemical engineering, pharmaceutical chemistry, biochemistry, or appropriate technical discipline with at least 8 years of industry bioprocess development in a manufacturing environment
  • Experience working with monoclonal antibodies, antibody conjugates, and small proteins, is preferred with demonstrated expertise in upstream and/or downstream process development and analytical expertise is highly advantageous
  • Proven technology transfer and scale-up experience, from development lab to cGMP manufacturing
  • Experience in management of outsourced manufacturing/development activities at CMOs
  • Strong project leadership and resource management skills with the ability to perform in a cross functional project team
  • Ability and willingness to wear multiple "hats" in an entrepreneurial organization
  • Excellent written and oral communication skills

 

If you require accommodation for your application or interview, please contact Human Resources directly at 905.525.9140 ext. 21112 or by email at careers@imagingprobes.ca

 

We thank all those who apply but only candidates selected for interviews will be contacted.

 

Fusion Pharmaceuticals
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