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Head of Chemistry, Manufacturing and Controls (CMC) - Vaccine Development

Job Title: Head of Chemistry, Manufacturing and Controls (CMC) - Vaccine Development
Contract Type: Permanent
Location: Brisbane
Industry:
Reference: 629296
Contact Name: Peter Starling
Job Published: May 11, 2021 06:01

Job Description

Vaxxas is a fast growing and scale-up stage biotech company developing a novel vaccine delivery system that safely and cost effectively amplifies vaccine efficacy. It is an advanced platform that vaccinates by applying a patch to the skin for a few seconds directly depositing vaccine amongst a dense population of key immune cells.
  
Reporting to the Chief Development and Operations Officer, the Head of CMC will proactively lead multiple vaccine projects coordinating with key internal and external stakeholders to advance our vaccine portfolio with the main focus being the application of knowledge and methodology for the treatment and prevention of human disease.
  
The primary responsibility of this position is to work collaboratively with a focus on effective communication, planning, coordination of activities, and efficient implementation of the CMC development and supply strategy.
  
From an operational and delivery perspective, the Head of Chemistry, Manufacturing and Controls (CMC) – Vaccine Development will:

  • Applies knowledge and methodology of physics, engineering, mathematics, computing, physical chemistry and materials science to problems in biology and the treatment and prevention of human disease
  • Manage key projects within established scope, schedule, and budget that deliver required outcomes. Those outcomes being vaccine development projects with key industry partners
  • Lead multiple product development and aligned CMC requirements as well as process development and scale-up manufacturing to volume stages
  • Setup CMC strategy and planning, including scenario building and risk management across development pathway: including drug substance, pharmaceutical and device development and manufacture of clinical trial material and planning for commercial manufacturing

To be successful in this role you will have experience as a Head of Chemistry, Manufacturing and Controls (CMC) – Vaccine Development role within a similar company. You will have experience across the following:

 

  • Bachelor’s degree in Biological Sciences, Bioengineering; Advanced degree is considered an asset
  • Registration or licensing may be required so a working knowledge of US and European regulatory requirements would be of interest
  • Pharmaceutical, biotechnology, and/or medical device industry with a primary focus on project/program management of CMC related activities
  • Managing Contract Manufacturing Organisations (CMO) and Contract Research Organisations (CRO) relationships and projects. This will require developing key working relationships with vaccine manufacturing partners
  • Biological drug product development phases and regulatory requirements
  • Planning, project management, and organisation with the ability to lead multiple activities and resources while maintaining a focus on quality
  • Analytical and strategic capabilities combined with business acumen and a demonstrated track record of work ethic, integrity, and professional conduct and appearance

If you are an entrepreneurial, innovative team focussed individual who is committed to achieving corporate objectives whilst maintaining the highest ethical, regulatory and scientific standards and you are excited by the prospect of the challenges and enjoy rolling up your sleeves, we want to hear from you!
  
This role will see you form part of a dynamic “scale-up” environment and the ability to travel both domestically and internationally is a must. This position offers the ability to think strategically whilst executing critical projects along with an attractive remuneration package.
  
To be considered, please submit your resume and a cover letter (outlining your core capability for the role, demonstrated experience of how you have delivered outcomes and why this role is of interest) both in Word format to p.starling@ontalent.com.au . 
  
Confidential enquiries can be made to Peter Starling, Senior Client Partner at OnTalent 07 3305 5830 or 0433 422 518.

 

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