Quality and Scale-Up Specialist

7 days ago


Wellington, Wellington, New Zealand Evithé Biotechnology Full time

**Role Summary:**

We are seeking a skilled Quality and Scale-Up Specialist to join our team at Evithé Biotechnology. As a key member of our CMC team, you will play a pivotal role in ensuring the quality and consistency of our herbal supplements and medical food product lines. You will work closely with our R&D team to develop and optimize CMC processes and collaborate with contract manufacturers to ensure compliance with regulatory requirements.

**Responsibilities:**

  • Develop a long-term, processing-driven technical strategy that integrates seamlessly into the product innovation pipeline.
  • Lead the development and optimization of CMC processes for herbal supplements and medical foods and the development of the botanical drug pathway.
  • Ensure that product formulations and manufacturing processes are compliant with National Medical Products Administration (NMPA) regulations, GMP standards, and other relevant industry requirements.
  • Oversee the budget to scale the manufacturing and arrange the process.
  • Lead the expansion of the manufacturing facility in different demographics.
  • Manage the scale-up of manufacturing processes, ensuring product consistency, quality, and efficiency as production volumes increase.
  • Provide technical oversight and support for the transition of products from lab scale to full-scale manufacturing.
  • Manage scale-up transition from pilot plant into full-scale production.
  • Develop basic engineering design data, define operating conditions, and critical limits.
  • Establish safety parameters for the commercial process through scale-up and modeling of unit operations.
  • Ensure that all products meet the necessary specifications, including stability, safety, and efficacy standards.
  • Work with contract manufacturers to ensure that all production processes are efficient, cost-effective, and compliant with ICH & GMP and other regulatory standards.
  • Design, direct, and coordinate work with external research partners to supplement internal experimental programs.
  • Oversee the preparation and review of product specifications, batch records, manufacturing protocols, and other necessary documentation.
  • Lead risk assessments and troubleshoot any manufacturing or process-related issues that may arise during scale-up.


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