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Technical Development Leader - Pharmaceuticals (BH-8830)


Location
Auckland, New Zealand
Sector
Other
Salary
Positive career path options

  • Stable and growing business
  • Key contributor to new product development and regulatory approval
  • Key strategy level position
  • Positive career path options
Our client is a New Zealand owned and operated manufacturer of pharmaceutical products.  Their cGMP accredited facility manufactures a broad range of products for local and export markets. In contrast to some New Zeeland pharmaceutical manufacturers, this company is in growth mode with new products coming online and international customers already engaged with them.  With a stable leadership team steering the business forward, this is an excellent time to be joining such a company.
 
They currently have a vacancy for a Technical Development Leader within their Technical and Quality team. This newly created position is tasked with leading the technical development of existing and new products, including technology transfer products, to achieve license approval with regulatory authorities. You’ll also lead a team of two including one validation engineer.
 
Key responsibilities include:
  • Formulating a scientifically sound and business driven technical strategy, in line with overall project strategy, functional experts and managers. 
  • Preparing and presenting information related to the technical development aspects as requested at internal senior management team meetings and external health authority meetings.
  • Implementing and managing the technical development strategic plan for assigned projects (internal or external), ensuring all critical project milestones are met while maintaining a high level of quality.
  • Proactive communication of overall project development & technology transfer strategy and status, key issues/risk and any other critical topics in a timely manner to the Senior Management Team.
  • Identify the strategic risks related to the technical development plan, and ensures development of mitigation strategies and contingency options.
  • Drive the preparation, execution of method, product development and validation at laboratory scale, and production pilot and commercial scale.
  • Deliver reports to customer for submissions to the regulatory authorities (MPI ACVM, APVMA, MEDSAFE, TGA & FDA) in compliance with document management and data integrity standards.
  • Contribute to achieving project targets for customer medicine applications to support products into market
As the successful candidate will ideally possess the following attributes:
  • A relevant PhD or Masters degree in Science/Technology/Pharmaceuticals
  • 8+ years experience in commercial development of human or veterinary pharmaceutical products
  • Excellent knowledge and firsthand experience of pharmaceutical product development including regulatory, quality and clinical requirements
  • Experienced in working through the entire product registration process with ACVM, MEDSAFE, FDA or similar
  • Very strong attention to detail
  • Highly developed communication and organisational skills
  • Deliver results within tight deadlines
  • Provide support and training to colleagues across the business
This is an excellent opportunity to have a significant impact to pharmaceutical technology transfer in one of the few companies remaining in New Zealand that do this.
 
This pharmaceutical manufacturer has extensive business coverage from the full value chain in product development, regulatory, production to sales and a diversified product portfolio covering both animal veterinary medicine, human medicine and cosmetics with a growing number of international clients. They've pioneered many game-changers in delivering human and veterinary medicines and cosmetics to market, and we're looking to our customers' needs to guide us into the future.  Now is a fantastic time to be become part of this success story.
 
For a confidential enquiry or to apply for this position please click on the APPLY button. Alternatively contact Tony De Barr on 04 916 0541 or email tony@trs.co.nz
Note: If this vacancy is not exactly what you are seeking, then please contact me in confidence to discuss your individual requirements