Purpose of the position

To provide upstream and downstream bioprocess development support within Ipsen, including generation of feedstocks needed for development of downstream process stages.  The purpose of this role is to provide molecular biology, protein purification, upstream and downstream process development (USP & DSP), support technical transfer and provision of final and in-process non-GMP drug substance stocks as required, in support of Ipsen’s Biologics Development organization at its Milton Park site. This will be achieved by developing and optimising upstream and downstream processes suitable for the phase of development, performing fermentation and purification of target biologics and working in close collaboration with the Ipsen Biologics Pharmaceutical Development team at Ipsen, Wrexham and Drug Discovery, Neurology at the Milton Park site.

Main responsibilities and tasks

Main Responsibilities

Main Tasks

  • Delivery of bioprocess development and biomanufacturing to progress Biologics Development project activities
  • Perform USP and DSP process development activities at Milton Park, to develop manufacture processes suitable for the phase of development.
  • Enable delivery of process development through provision of molecular biology, protein purification, upstream and downstream process development (USP & DSP) and technical transfer to manufacturing environments (e.g. Ipsen Biopharm, Wrexham and CMOs), as necessary.
  • Support scouting and evaluation of new process/manufacturing technologies, including high throughput process development solutions.
  • Implement delivery of non-GMP drug substance materials for use in early development activities through planning and on-time delivery of small scale batch manufactures, to agreed quality and quantities.
  • Effectively plan and perform laboratory activities, including protocol and report writing where required.
  • Support process development activities for multiple products, ensuring effective communication and coordination with other members of process development and analytical teams (at both Milton Park and Wrexham sites) such that key Biologics Development deliverables are achieved.
  • Actively participate within internal functional and cross-functional teams, providing updates on progress and plans.
  • Provide in-process testing as required to support process development.
  • Support implementation of Design of Experiment approaches to process development.
  • To act in accordance with Ipsen’s Health, Safety & Environment, Quality and Regulatory requirements in all aspects of work.
  • Develop the science and knowledge base for process development activities within Ipsen R&D
  • Be an effective ambassador for Ipsen, seeking opportunities to influence the internal and external environments.
  • Maintain high level of expertise through review of current scientific literature, submissions to scientific journals, and attendance and participation at conferences.
  • Build the culture and the science by increasing product process knowledge) through good quality, impactful communications and presentations.
  • Foster stronger partnerships and collaborative working across Global Drug Discovery and Biologics Development teams at both Milton Park and Wrexham sites, R&D and support external relationships (CRO, CMO, academic and industry collaborations) to strengthen scientific and technical expertise.

Experience / Qualifications

  • Experience & Qualifications:

 

Ideal:          PhD in a related biosciences field, with 3+ 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

Technical 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