To provide bioprocess development expertise, strategy and support within Ipsen and to evaluate new technologies for improvement of manufacturing processes.  This role is responsible for the leadership and delivery of bioprocess development for manufacture of novel protein therapeutic candidates within the Biologics Development CMC group based in Milton Park, Oxfordshire (Ipsen Bioinnovation site). The purpose of this role is to provide molecular biology, protein purification, upstream and downstream process development (USP & DSP), technical transfer and evaluation of new technologies to improve these processes, with focus on DSP, in support of Ipsen’s R&D organization at its Milton Park site. This will be achieved by developing and optimising upstream and downstream processes suitable for the phase of development, as well as actively evaluating opportunities for technology improvements and evaluating these internally in close collaboration with the Ipsen Biologics CMC Development team at Ipsen Wrexham and with Global Drug Discovery, Neurology at the Milton Park site.

Main responsibilities and tasks

Main Responsibilities

Main Tasks

Leadership

  • Lead and plan process development activities at Milton Park, with focus on DSP.
  • Act as Technical Lead for Process Development within CMC Project Teams, providing updates on progress and plans.
  • Lead scouting and evaluation of new process/manufacturing technologies, including high throughput process development solutions.
  • Be an effective ambassador for Ipsen, seeking opportunities to
  • Ensure the logistical and scientific integrity and delivery of bioprocess activities for progression of R&D projects (e.g. lead optimisation, candidate validation, support of pre-clinical manufacturing).
  • To act in accordance with Ipsen’s Health, Safety & Environment, Quality and Regulatory requirements in all aspects of work.

Delivery of bioprocess development and biomanufacturing to progress Biologics Development project activities

  • Provide expertise in molecular biology, protein purification, upstream and downstream process development (USP & DSP) and technical transfer to manufacturing environments (e.g. Ipsen Biopharm, Wrexham and CDMOs) to support Biologics CMC Development project activities, as necessary
  • Support implementation of Design of Experiment approaches to process development.
  • Develop and implement process development and product supply plans which deliver on time, to the expected quantity and quality.
  • Provide technical leadership and expertise to introduce and implement new and innovative process development technologies. 
  • Support the selection of suitable external partners to provide biomanufacturing services in support of development projects if required.

Experience / Qualifications

Ideal:          

  • PhD in a related biosciences field, with 5+ years relevant industrial R&D experience and expertise
  • Working within contained laboratory conditions

Minimum: Degree level or equivalent,

  • Protein purification and process development experience and expertise

Required Competencies

  • Expertise in protein expression, purification and process development
  • Experience in molecular biology, protein handling, in-process analysis
  • Knowledge and experience of GMP Biomanufacturing
  • Knowledge and understanding of botulinum neurotoxin biology