Quality and Scale-Up Specialist
7 days ago
**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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