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Principal Scientist - Lyophilisation

  • Salary: Negotiable
  • Job type: Permanent
  • Location:
  • Sector: Other
  • Date posted: 27/08/2018
  • Job reference: BBBH15516

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Principal Scientist - Lyophilisation

Why is this role open?

Our client have a new vacancy for an Lyophilisation Scientist which sits within the Research & Development team who have just moved into a state of the art sterile fill finish site and are in the process of working with a new line of products. The role is to support the design and scale-up of lyophilisation processes suitable for clinical production, including cycle optimization, robustness studies, and technology transfer. Candidates should have biotechnology educational attainments, a minimum of five years' experience within the pharmaceutical industry, preferably in a Biopharma role with significant exposure to Lyophilisation & cycle development, and have ideally worked within an aseptic fill finish environment.

What will you be doing?

  • Advise on lyophilisation cycle development, optimization, scale up and Technology Transfer of finished products using state of the art techniques
  • Design and execute accelerated stability testing plans that demonstrate suitability of Lyophilised formulations
  • Complete required batch documentation records with accuracy and legibility
  • Ensure product quality by performing in-process checks, complying with current good manufacturing practices
  • Track and report deviations to a process, initiating quality improvements and participating on quality improvement projects as required.
  • Act as R&D liaison between relevant Managers, Q A, Research, Tech Services, Engineers and Maintenance personnel in all matters regarding freeze drying
  • Participate on manufacturing project teams to assist with cycle development through collaboration with R&D.
  • Review work scope, rationale, approvals, changes to appropriate equipment/systems and re-qualification activities
  • Assist in the training of sterile operators or cross-training in other areas.
  • Troubleshoot and perform adjustments on equipment as required.
  • Ensure that all work is carried out in compliance with the required standards to conform to company, cGxP, health and safety, environmental and regulatory requirements.

What we need from YOU:

  • You MUST be passionate about Lyophilisation and Biopharma
  • An honours degree in Science/Biotechnology (or a related discipline)
  • You MUST have at least 5+ years' experience
  • Significant exposure to Lyophilisation & cycle development
  • Ideally have worked within an aseptic fill finish environment
  • Demonstrated knowledge in pharmaceutical / biopharmaceutical technical / manufacturing operations.
  • Self-starter who enjoys working in a fast paced environment
  • You MUST enjoy working as part of a team and be fun and friendly

What makes us different:

  • We are a fun and exciting place to work!
  • We have an incredibly broad range of products; Generics and New Drug developments; Human and Veterinary; we have a strong Clinical team in-house; substantial R&D capacity - all of which makes us very autonomous and self-resourced to deliver projects.
  • We encourage growth from within and like to promote our employees where we can
  • We want to develop our employees and so we encourage them to undertake further training and courses wherever possible
  • Diversity matters to us
  • Our open door policy ensures that everyone's ideas are heard
  • Not too many pharma companies can boast that they have a purpose built R&D Centre.
  • Everyone sits together in the canteen - it doesn't matter who you are!
  • We can proudly boast about our client which is the value we place on the fun, informal work environment, and the innovative and supportive people that make up our team