Pharmaceutical Bioprocessing Project

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Bioprocessing in the pharmaceutical manufacturing sector is a burgeoning field, attracting investments and creating job opportunities. As it involves the use of living organisms to manufacture products, bioprocessing requires more complex methods than other forms of pharmaceutical processing. With a growing workforce the industry faces a challenge in maintaining compliance to industry standards. However, there is also opportunity for innovation.The skills required by this emerging workforce are not currently addressed within the vocational education and training sector. As part of this project, the current units of competency in pharmaceutical processing will be reviewed and additional units developed where necessary in order to support the more complex compliance requirements and processing methods of bioprocessing.
This project was submitted as part of the Australian Food, Beverage and Pharmaceutical Product Manufacturing IRC Skills Forecast and Case for Change 2018-21 (see pages 78-81). However, as one of the key stakeholders CSL Behring was not available to contribute at the time, the Food, Beverage and Pharmaceutical IRC made the decision to defer the project until a later date. Given the specialised nature of this field and the emerging skills within it, the contributions of this major stakeholder were essential to the process of industry consultation.The project was later approved by The Australian Industry and Skills Committee (AISC) out of the 2019-2022 Australian Food, Beverage and Pharmaceutical Product Manufacturing IRC Skills Forecast and Proposed Schedule of Work (see pages 3).Skills Impact and the Food, Beverage and Pharmaceutical Industry Reference Committee (IRC) will manage this project, consistent with the 2012 Standards for Training Package Development.Download Project Proposal (see pages 78-81) 

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Pharmaceutical bioprocessing techniques are now making it possible to treat some illnesses where no other treatments were previously available. This expanding field involves harnessing bacteria, yeast or mammalian cells for use in immunology, pharmaceutical therapies or diagnostic tests. The skills standards of those working in manufacturing and distribution of pharmaceutical bioprocessing products are unique to traditional pharmaceutical manufacturing.As pharmaceutical bioprocessing relies on the behaviour of living organisms, there are many variables to be considered in the manufacturing process. In order to get consistent results in treatment and diagnosis it is essential to mitigate product degradation, process variability and contamination. Workers in this area also require high level analytical skills to work with new technologies and interpret data.
While it is evident that pharmaceutical bioprocessing requires specialised skills and knowledge, no nationally endorsed units of competency are currently available in this specific area. Consultation with industry will continue throughout this project to address the need for these skills standards. This project will include a review of current units in pharmaceutical manufacture, and potential development of new units of competency or qualifications to reflect the more in-depth analysis and compliance required for bioprocessing.
Project Scope
This project will identify the skills standards for pharmaceutical bioprocessing manufacturing work and reflect these in vocational skills standards, supporting training opportunities in this field.

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Subscribe to the Skills Impact newsletter to keep informed about project updates and opportunities to provide input and feedback. Make sure to select ‘Food, Beverage & Pharmaceutical’ as your industry of interest.
Relevant Occupations
Relevant occupations include but are not limited to:
  • Manufacturing operators
  • Plant operators
  • Bioprocess technicians
  • Quality assurance and quality control staff
  • Research and development staff
  • Fill finish/packaging operators
  • Project managers
  • Stock management and distribution staff
Project Team
Cathy BevenIndustry Skills Standards Specialist, Skills Impactcathy@skillsimpact.com.au
Julie StratfordIndustry Engagement Manager, Skills Impactjstratford@skillsimpact.com.au
William HendersonIndustry Skills Standards Developer, Skills ImpactWilliam@skillsimpact.com.au
 
Timeline
September 2019 Initial scopingOctober 2019 to January 2020 Development of draft qualifications, skill sets and unitsMarch 2020 Drafts available for broad consultationApril 2020 Validation of final draftsMay 2020 Finalisation of Training Package componentsJune 2020 Independent Quality Assurance, and Edit and Equity review of Training Package componentsAugust 2020 IRC consideration for sign-off and submission for endorsement
Subject Matter Experts
Subject Matter Experts will be drawn on throughout this project to help review units, skill sets and qualifications, and produce drafts to address the necessary skills.If you are interested in applying to be a subject matter expert and are able to volunteer your time to this project, please email details of your expertise to cathy@skillsimpact.com.au.
Opportunities for stakeholder input
Stakeholder input is appreciated throughout the duration of this project. The documents will be drafted in consultation with Subject Matter Experts and their networks. Opportunities to provide targeted feedback will occur when the draft materials are made available in March 2020, and again for validation of final drafts in April 2020. However, your feedback is welcomed at any time, and will help us in drafting the documents. It is important that training provides a skilled and flexible workforce for the future and that qualifications, skill sets and units of competency reflect real work experience. So if you work in the sector, Skills Impact would love your input and help. Please feel free to register your interest for project updates and consultation opportunities by following the newsletter subscription link below. Alternatively, please feel free to contact the project manager, Cathy Beven on 03 9321 3526 or cathy@skillsimpact.com.au.
Stakeholder Consultation Process
A list of key stakeholder organisations has been identified for this project. Skills Impact will ensure contact is made with each of these organisations during the development of this project to seek their involvement and their views on the draft qualifications, skill sets and units.If you are aware of an organisation that you think should be involved, please encourage them to contact the project team and/or direct them to this webpage.Of course, all and any interested industry participants are encouraged to engage in the consultation of this project, when the draft qualifications, skill sets, and units are available for feedback via this webpage and workshops that take place around Australia. Consultation is not limited to the organisations on this list. This list simply helps us to identify those organisations that, because of their industry role, size or specialty, are likely to have a key interest in the development and outcomes of this project.The Australian Food, Beverage and Pharmaceutical Product Manufacturing (IRC) will oversee this project, as part of their responsibilities to support engagement with the sector, and to ensure projects meet industry stakeholder needs. 

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