Protein Expression and Purification Scientist

**Job Advert Summary**:
The purpose of the Protein Expression and Purification Scientist position is to oversee and perform all the activities associated with the development, expression, purification and analysis of diagnostic and therapeutic proteins in NBI’s Biotechnology Product Development laboratory.

**Minimum Requirements**:

- Masters degree in Biotechnology, Chemical Engineering or other relevant degree.
- PhD in Biotechnology preferred.
- Minimum of 3 years’ experience GMP or Biotechnology environment.
- Successful track record in the field of Biotechnology R&D project management.
- Broad experience in the analysis of complex formulations.
- Minimum of 3 years’ experience in protein expression and purification systems, with mammalian and bacterial cell culture experience preferred.
- Experience in synthesis, purification and analysis of synthetic peptides preferred.
- Experience in transfer of methods and data to other laboratories preferred.
- Any experience in plasma-derived therapeutic proteins is a plus.

**Duties and Responsibilities**:
**Grow and maintain NBI’s therapeutic protein and diagnostic development capabilities **in line with strategic and business objectives.**

In collaboration with the Head of Biotechnology Product Development to:

- Equip, implement and maintain a well-resourced protein expression, purification and analysis capability in the Product Development laboratory.
- Prepare User Requirement specifications to support the purchasing of the required process and analytical equipment.
- Collaborate with internal stakeholders such as the Validation team to ensure equipment are correctly installed, commissioned and qualified.
- Manage NBI’s therapeutic protein development projects in terms of activities, timelines and resources.
- Review scientific literature, abstracts, patents, and applicable laboratory methods as appropriate to prepare technical reports relating to identified development projects.
- Provide high level report back on NBI’s protein expression and purification capabilities and progress.
- Participate in internal and external technology transfer projects to establish protein expression and purification capabilities and capacity at NBI.
- Collaborate with other functions/departments within NBI to improve existing pharmaceutical products and create new products.
- Participate in the planning and design of production areas for therapeutic product manufacturing meeting GMP and other requirements.
- Ensure up to date knowledge of appropriate technologies in the biotechnology field as it related to biologics/biosimilars through extensive reading, research and maintaining and developing contacts with experts in the field.
- Support the preparation of proposals and business plans to external stakeholders for funding.

**Establish, grow and optimise NBI’s therapeutic protein expression systems**
- Provide technical and scientific input to identify appropriate protein expressions systems, based on the therapeutic protein. These include bacterial, yeast and mammalian cell lines. Follow project management and design of experiment approaches to optimise the yield of expressed proteins of interest.
- Optimize peptide synthesis, purification and associated analytical methods.
- Perform scale-up studies.
- Manufacture sufficient quantities of protein for downstream process developmental activities.
- Assist with the establishment of appropriate analytical techniques to analyse the proteins of interest in terms of purity, first order and higher order structure, post translational modifications etc.
- Develop protein expression processes leading to the reproducible, practical and economical production of therapeutic proteins, in line with cGMP and other quality requirements.
- Troubleshooting to effectively resolve technical, quality or resource issues.

**Downstream protein purification process development**
- Identify and establish the equipment required for downstream production processes such as protein purification and PEGylation.
- Provide technical and scientific input to identify appropriate protein purification strategies and systems to prepare solutions of proteins meeting compendial requirements.
- Perform process optimisation and scale up studies to maximise protein yield while maintaining the required protein structure, purity, post-translational modifications, etc.
- Meticulously record all process development activities and prepare detailed SOPs to allow for effective internal technology transfer and the preparation of product dossiers.
- Troubleshooting to effectively resolve technical, quality or resource issues.

**Management of NBI’s RCB’s and establishment of master and working cell banks.**
- Characterise and maintain NBI’s RCB’s to support the establishment of the MCB and WCB’s required for GMP production.
- Propagate the cell lines to ensure sufficient quantities of cells are available.
- Implement effective strategies to ensure th