Protein Expression and Purification Scientist 21 views

Job Overview

  • Salary Offer Market related
  • Experience Level Senior
  • Total Years Experience 5-10

Purpose: 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 the institute’s biotechnology product development laboratory.

 

Key Job Outputs:

Grow and maintain the institute’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 the institute’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 institute’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 institute
    • Collaborate with other functions/departments within the institute 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 the institute’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
  • 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 the institute’s RCB’s and establishment of master and working cell banks

  • Characterise and maintain the institute’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 the quality and integrity of the cell banks during prolonged storage
  • Collaborate with third party CRO’s to perform formal cell characterisation and cell banking activities
  • Ensure that the cell line history and characterisation is recorded and all the required documentation is prepared to support the cell banking activities

Technology transfer of completed products and processes to internal recipients

  • Prepare detailed product development reports, SOPs, specifications and other information that is required for the successful transfer of the product and further clinical and non-clinical development
  • 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

  • Identify and ensure application of and adherence to relevant quality management system requirements from conception stages throughout the life cycle of acquired product development, ultimately to ensure final product registration
  • Ensure applicable quality systems and regulations are followed in the product development laboratory
  • 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
  • Ensure QMS guidelines are used during transfer of new products or process improvement to production or routine operation

General laboratory administration and support

  • Prepare budgets for the protein expression and purification laboratory
  • Prepare monthly cost centre reports
  • 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 the institute’s QMS requirements
  • Provide other technical support to routine production and the biotechnology department as and when required

Specific SHE Requirements

  • Pre-employment, routine, and exit medicals are compulsory due to the nature of the business
  • Attendance to SHE-related training is mandatory
  • Adherence to SHE Instructions (Waste Segregation, Water and Energy Saving Initiatives)
  • Compliance with SHE Site Rules is compulsory
  • The institute uses hazardous and biologically active chemicals, successful candidate will be required to use proper PPE and will go through medical examinations as per OSH Act 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

Qualifications:

  • Masters degree in Biotechnology, Chemical Engineering or other relevant degree
  • PhD in Biotechnology preferred

Experience:

  • Minimum of 3 years’ experience GMP or Biotechnology environment
  • One year experience of expressing proteins in a Bioreactor
  • 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

 

Salary:   Market related

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