Technology Lead

2 weeks ago


New Zealand Technical Recruitment Solutions Full time

Stable and growing business
- Key contributor to new product development and regulatory approval
- Auckland location

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. The company is in growth mode with new products coming on line and international customers lining up to engage 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 Technology Lead with their Technical and Quality team. This newly created position will play a critical role in the development of new pharmaceutical formulas from laboratory, through pilot plant and on to commercial scale. Key responsibilities include:

- Participating in strategic senior management review of product development for generic human and veterinary medicines through various dosage forms
- Provide update on status of executions of multiple projects as well as new customer technology transfers
- Developing formulas at lab scale, production pilot and commercial scale and generate reports for justification of release and stability specifications for eventual human and veterinary medicine
- Supporting technical review and generation reports associated with technology transfers, including:

- Reviewing reports for submission to agencies for extension of shelf life and change in specification
- Reviewing method and process validation reports and coach on execution where necessary to ensure any changes required on first process validation batch
- Providing adequate responses to request for information to regulatory authorities related to new medicine and changes to existing medicines

You’ll be competent to write reports with supporting data and technical justification to government regulators, have the proven ability to interact with customers, senior management and cross functional teams, and deliver result and signed documents for existing and new medicines for growth and export opportunities.
- A relevant PhD or Masters degree in Science/Technology/Pharmaceuticals
- 10+ years experience in commercial development of human or veterinary pharmaceutical products
- 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.
- Note: If this vacancy is not exactly what you are seeking, then please contact me in confidence to discuss your individual requirements._



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