CMC Process Expert

6 days ago


Wellington, Wellington, New Zealand Evithé Biotechnology Full time

**About Us:**

Evithé Biotechnology is a rapidly growing startup in the health and wellness industry, committed to harnessing the power of natural health products to improve human well-being. We are passionate about creating a new treatment modality for inflammatory diseases and supporting healthy aging through our scientifically validated herbal supplements, medical foods, and pharmaceutical drugs.

We are seeking a highly experienced CMC Specialist to join our team and play a pivotal role in scaling up our manufacturing operations to large commercial scale. The ideal candidate will have extensive experience in CMC, particularly in herbal products, and will be responsible for ensuring that our products are consistently manufactured in compliance with regulatory requirements and meet high-quality standards.

This role offers a unique opportunity to work with cutting-edge technology and scale manufacturing processes to meet growing demand. If you are passionate about science-based natural health products and their positive impact on consumer well-being, we encourage you to apply.


**Key Responsibilities:**

  • Lead and manage multiple R&D projects, ensuring timely execution, technical excellence, and alignment with business goals.
  • 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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