Chemist
Job Description
Your Role
- Identification, planning, and setup of a Preparation Lab under cGMP guidelines, including cleanroom infrastructure.
- Reviewing manufacturing processes to ensure that they comply with standard procedures and cGMP practices.
- Reagent preparation & handling.
- Prepare chemical and biological reagents according to standardized protocols, SOPs, and batch records.
- Work in the preparation lab to maintain readiness for production needs.
- Ensure correct concentrations, pH adjustments, and dilutions as per specifications.
- Knowledge of accurate weighing, dilution, buffer preparation, molarity & normality calculations, and dilutions.
- Operate and maintain laboratory equipment (balances, pH meters, extraction hoods).
- Ensure aseptic handling and preparation of biological reagents in accordance with GMP and EHS guidelines.
- Chemical safety: Handling corrosives, flammables, oxidizers, and toxic reagents.
- Demonstrate safe, competent operation of lab and production equipment by complying with established procedures.
- Support validation activities as required, ensuring accuracy and adherence to established protocols.
- Maintain accurate records of production activities, inventory levels, and equipment maintenance logs.
- Ensure proper handling and disposal of hazardous materials in accordance with environmental regulations.
Who You Are
- 3-6 years of strong knowledge of organic and inorganic chemistry and reagent preparation techniques.
- Familiarity with GMP, ISO 9001, and laboratory safety practices.
- Basic understanding of lyophilization techniques.
- Basic knowledge about data integrity.
- Maintain current knowledge of regulatory and industry standards and advancements through independent reading and training.