Head of Manufacturing, Targovax

Head of Manufacturing, Targovax

We are now looking for a Head of Manufacturing to Targovax, a clinical stage immuno-oncology company with headquarter in Oslo, Norway and CMC facility in Espoo, Finland. This is a central role where you will be part of the management team, report to the CEO and lead a highly experienced CMC team to support the development of robust scale-up processes for oncolytic virus manufacture.  

 As the company’s senior expert in CMC, you will be responsible for establishing Targovax’s large-scale production leading up to commercialization. Targovax’s immunotherapeutic technology makes tumors visible to the immune system and educates the immune system to recognize and attack patient specific tumor cells. The focus is to “activate the patient’s immune system to fight cancer”, thus extending and transforming the lives of cancer patients with targeted therapeutic cancer immunotherapies. Targovax’s pipeline aims at different cancer indications, including melanoma, mesothelioma, and colorectal cancer. The next development steps for Targovax’s lead clinical candidate is ONCOS-102, will involve a clinical trial with registration intent in checkpoint inhibitor refractory melanoma.

 

Responsibilities

  • Manage, develop, and execute scale-up processes of oncolytic viruses
  • Prepare the large-scale production for commercialization to deliver against the strategic plan
  • Lead and develop the CMC team to create and maintain a team-based and proactive culture of continuous improvement
  • Support the development projects as senior CMC expert
  • Provide strong technical leadership and manage the relationships with the company’s CDMO partner
  • Ensure that all processes and production activities are compliant with GMP and regulatory requirements
  • Prepare reports and CMC sections for regulatory filings
  • Estimating and agreeing the manufacturing budget
  • Manage logistic processes

 

 Skills & Competencies

  • Possess capability for long-term planning, problem solving and optimizing work
  • Be a team player with managerial aptitude
  • Ability to argue, influence and convince stakeholders
  • Work effectively in high pressure situations
  • Competence to distinguish between what is critically necessary and what is not
  • Competence to prioritize between commercial realities and technical best practice

     

Must-have Requirements & Qualifications

  • PhD or M.Sc. degree in Biotechnology, Bioprocess Engineering or similar
  • Extensive industry experience and knowledge of bioprocess scale-up technologies
  • Experience in CMC development in Phase III and Commercial
  • Experience in negotiating and drafting of commercial quotations and agreements
  • Experience in biological/biotechnological/medicinal products/ATMP or similar
  • Experience in working according to GMP regulations.
  • Excellent communicator, both in verbal and written English
  • Willingness to travel and spend time in Oslo and Espoo offices 

 

Beneficial Requirements & Qualifications

  • Experience in large-scale manufacturing process characterization and validation
  • Experience in cell biology/virology is an asset, peptide/protein experience is beneficial
  • Regulatory experience in CMC, preferable in biotechnological products/ATMP
  • Experience in leading a team
  • Experience in CDMO sourcing and collaboration
  • Finnish language skills are beneficial

  

For more information please contact:

Anna Emterling +46(0)76-313 0137, anna.e@haegercarlsson.com

Rolf Carlsson +46(0)70-316 1268, rolf@haegercarlsson.com

Welcome to apply through www.haegercarlsson.com

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