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.

• Manage NBI’s therapeutic protein development projects in terms of activities, timelines and resources.
• Participate in the planning and design of production areas for therapeutic product manufacturing meeting GMP and other requirements.
• 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.
• Identify the most appropriate bioreactor configurations and media composition for specific applications.
• 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 using techniques like HPLC, LC-MS, Capillary Zone Electrophoresis etc.

Downstream protein purification process development

• Provide technical and scientific input to identify appropriate protein purification strategies and systems to prepare solutions of proteins meeting compendial requirements.
• Meticulously record all process development activities and prepare detailed SOPs to allow for effective internal technology transfer and the preparation of product dossiers.

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.
• Implement effective strategies to ensure the quality and integrity of the cell banks during prolonged storage.

Technology transfer of completed products and processes to internal recipients

• Coordinate the pilot scale manufacturing of the developed products by working directly with the relevant internal stakeholders.
• Provide technical advice and troubleshooting support to the internal recipients relating to the developed products and processes to ensure that the production processes are effectively transferred.

Maintain the quality system to support successful product development

• Prioritize and implement principles and guidelines of GMP, ISO 14971, 13485 and related standards in the development studies.
• Participate in root cause investigations, risk assessments, and the identifications of corrective and preventive actions (CAPA’s) to ensure continuous improvements.
• Establish and maintain a laboratory information management system to ensure all product development activities are correctly and accurately recorded.

General laboratory administration and support

• Prepare budgets for the Protein Expression and Purification laboratory.
• Manage the reference standards, reagents, media, consumables and utilities required for the protein expression, purification and cell culture maintenance.
• Ensure analytical other laboratory equipment are calibrated and maintained in line with manufacturer’s and NBI’s QMS requirements.

Core Competencies

• Managing Relationships
• Personal Leadership
• Business Impact
• Leading and Influencing Others
• Strategic and conceptual thinking and analytical ability
• Technical/professional knowledge
• Decision making
• Planning and organising
• Project management approach
• Analysis/problem solving
• Excellent verbal and written communication
• Service mindset, strong commitment to meeting Quality requirements
• Customer orientation