Senior Process Development Engineer

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We are seeking a Senior Process Development  Engineer experienced in managing technology transfers in our Montpellier (Jacou) facility. Reporting to the Senior Process Development Leader, the Process Engineer is responsible for identifying process improvement initiatives and develops proposals for problem-solving for the scale-up, and technology transfer of novel products and processes into manufacturing.

Responsibilities

  • lead and manage technology transfers through scale-up/down and scale-in/out to commercial product transfer
  • Determine and implement optimal sterilization techniques
  • Assess and implement optimal stability conditions
  • Write and review process validation protocols and reports, supportive to regulatory filling (IND, IMPD)
  • Ensure technology transfer targeted milestones and timelines are achieved
  • Prepare logistics and draft protocols for experiments; conduct experiments; observe results
  • Establish effective working relationships with contract development manufacturing organizations
  • Ensure the careful and complete documentation/archiving of all generated data, namely in our electronic lab notebook system
  • Conduct scientific literature research to resolve problems and make recommendations for improvement
  • Participate in meetings and/or teleconferences with development partners when required, communicating in English
  • Work closely with other team members and perform activities in response to priorities
  • Verify that established procedures are followed and quality standards are maintained

Experience / Education

  • Minimum of a Master’s degree in chemical engineering, Biochemistry or Medicinal chemistry.
  • Minimum of 3. years of experience (excluding internships) in sterile technology transfers
  • Experience in long-acting injectables would be a plus
  • Transnational/international educational or work experience
  • Strong skills in analyzing data and drawing scientifically sound conclusions
  • Fluency in English

General work attitude

  • Effective functioning in a rapidly changing environment and adherence to MedinCell values and mission
  • Consistency, precision, perseverance, directness and listening skills
  • Open-mindedness and ability to adapt to changing situations
  • Strong team spirit and open sharing of all the information necessary to successfully achieve overall work goals
  • Desire to continuously improve and progress
  • Strong work ethic

 


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