Chemist 1 – Preparation Laboratory Operations
Location: Bangalore, Karnataka, India
Employment Type: Full-Time
Work Mode: On-Site
Role Summary
The Chemist 1 – Preparation Laboratory Operations is responsible for supporting the establishment, operation, and maintenance of a cGMP-compliant Preparation Laboratory, including cleanroom infrastructure and reagent preparation activities. The role focuses on ensuring accurate preparation of chemical and biological reagents, maintaining laboratory readiness, supporting validation activities, and ensuring compliance with quality, safety, and regulatory standards.
This position requires strong expertise in organic and inorganic chemistry, laboratory operations, reagent preparation, chemical safety, and cGMP practices to support manufacturing and quality objectives.
Key Responsibilities
Preparation Laboratory Setup & Operations
Support the identification, planning, and setup of a Preparation Laboratory under cGMP guidelines.
Assist in establishing and maintaining cleanroom infrastructure and laboratory readiness.
Ensure laboratory operations comply with:
cGMP Requirements
ISO Standards
Internal SOPs
Environmental Health & Safety (EHS) Guidelines
Maintain a production-ready environment to support manufacturing activities.
Reagent Preparation & Handling
Prepare chemical and biological reagents according to:
Standard Operating Procedures (SOPs)
Batch Records
Approved Protocols
Ensure accurate:
Weighing
Dilution
Buffer Preparation
pH Adjustment
Concentration Calculations
Perform:
Molarity Calculations
Normality Calculations
Solution Standardization
Verify reagent quality and compliance with established specifications.
Laboratory Equipment Operation & Maintenance
Operate and maintain laboratory equipment including:
Analytical Balances
pH Meters
Extraction Hoods
Mixing Equipment
Laboratory Utilities
Perform routine equipment checks and maintenance activities.
Ensure equipment calibration and documentation requirements are met.
Report equipment malfunctions and coordinate corrective actions.
Aseptic Processing & Biological Reagent Handling
Perform aseptic handling and preparation of biological reagents.
Follow GMP and cleanroom procedures during laboratory activities.
Ensure contamination control practices are consistently maintained.
Support activities requiring sterile handling techniques.
Manufacturing & Process Compliance
Review manufacturing processes to ensure compliance with:
cGMP Guidelines
Approved Procedures
Quality Requirements
Support manufacturing operations by providing prepared reagents and materials.
Ensure process documentation is accurate and complete.
Participate in process monitoring and continuous improvement initiatives.
Validation & Quality Support
Support qualification and validation activities as required.
Assist in protocol execution and documentation.
Ensure laboratory processes comply with validation requirements.
Support investigations related to deviations and quality events.
Maintain data integrity throughout all laboratory activities.
Chemical Safety & Environmental Compliance
Safely handle:
Corrosive Chemicals
Flammable Materials
Oxidizers
Toxic Reagents
Ensure proper storage, labeling, and segregation of chemicals.
Follow chemical hygiene and laboratory safety procedures.
Support hazardous waste management and disposal activities in compliance with environmental regulations.
Promote a culture of safety and compliance within laboratory operations.
Documentation & Inventory Management
Maintain accurate records of:
Reagent Preparation Activities
Batch Documentation
Equipment Maintenance Logs
Inventory Records
Ensure documentation is complete, accurate, and audit-ready.
Monitor inventory levels and coordinate replenishment of laboratory supplies.
Support laboratory audits and inspections.
Continuous Improvement
Identify opportunities to improve laboratory efficiency, quality, and safety.
Participate in process improvement initiatives and best practice implementation.
Stay updated with industry standards, regulatory requirements, and scientific advancements.
Support knowledge sharing and continuous learning within the team.
Required Qualifications
Education
One of the following qualifications:
Bachelor's Degree in:
Chemistry
Pharmaceutical Sciences
Biotechnology
Life Sciences
Related Scientific Discipline
OR
Master's Degree in:
Chemistry
Pharmaceutical Sciences
Biotechnology
Related Scientific Discipline
Experience
3–6 years of experience in:
Reagent Preparation
Laboratory Operations
Pharmaceutical Manufacturing Support
Quality Control Laboratories
cGMP-Regulated Environments
Experience working in cleanroom or controlled laboratory environments is preferred.
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