Chemistry, Manufacturing And Controls Specialist – Natural
2 days ago
Chemistry, Manufacturing and Controls Specialist – Natural & Drug ProductsCompany Overview:Evithé Biotechnology is a biotech startup company that specializes in harnessing defense compounds from plants and produced a brand new range of herbal supplements, medical foods, botanical drugs, and pharmaceutical drugs to provide a new treatment modality for inflammatory diseases and support healthy aging.
Evithé Biotechnology is in the process of completing phase 1 clinical trials and scaling up to go to market with our high quality, scientifically validated herbal supplements in China.
Following launch, we will expand into the medical food market, followed by botanical and pharmaceutical drugs.
Sustainability is important to us and our processes are designed to be sustainable from field to formulation.Job Overview:We are seeking a CMC Specialist to manage the Chemistry, Manufacturing, and Controls (CMC) aspects of our herbal supplements and medical food product lines.
The ideal candidate will have extensive experience in CMC, particularly in herbal products, and will play a pivotal role in scaling up manufacturing operations to large commercial scale, from plant to finished product.
You will be responsible for ensuring that products are consistently manufactured in compliance with regulatory requirements and that we meet high-quality standards as we scale.
This role is based in Wellington, New Zealand and includes international travel to manage the manufacturing and scaling processes.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.Qualifications:Bachelor's degree in Pharmaceutical Sciences, Chemistry, Biology, or a related field (Master's or PhD preferred).3+ years of experience in Chemistry, Manufacturing, and Controls (CMC), with a focus on herbal supplements or medical foods.In-depth knowledge of quality standards and regulations, GMP standards, and other regulatory requirements for dietary supplements and medical foods.Proven experience in scaling up manufacturing processes from pilot to commercial production.Strong technical skills in formulation, process development, and manufacturing scale-up.Familiarity with quality control procedures, product testing, and stability studies for herbal products.Ability to collaborate effectively with cross-functional teams, including R&D, regulatory affairs, and quality assurance.Strong problem-solving, organizational, and communication skills.Passion for science-based natural health products and their positive impact on consumer well-being.Why Join Us?Join an exciting, rapidly growing startup in the health and wellness industry.Work in a collaborative, innovative, and dynamic team environment.Competitive salary with opportunities for career growth and development.Be part of a company making a direct impact on improving health outcomes through natural and scientifically backed products.Opportunity to work with cutting-edge technology and scale manufacturing processes to meet growing demand.Preferred:Experience with plant-based formulations, ethanol extraction, and plant resins.Proficiency in project management software and data analysis tools.Familiarity with supply chain management and vendor relations for sourcing raw materials.Physical Requirements:Ability to work in a lab environment with exposure to chemicals, solvents, and various lab equipment.Ability to occasionally lift up to 25 kg and move materials for scaling purposes.Ability to travel internationally and be situated outside New Zealand for certain periods of time.Work will take place in a laboratory, office, and manufacturing floor environment.This job requires travel for sourcing materials, visiting production facilities, and attending conferences.Seniority LevelMid-Senior levelEmployment TypeFull-timeJob FunctionResearch, Analyst, and Information TechnologyIndustriesPharmaceutical Manufacturing
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