Sr. Officer / Executive (Oligonucleotide Manufacturing)

Role Purpose

To support the routine operation and execution of oligonucleotide manufacturing activities, including synthesis, deprotection, cleavage, purification, and formulation, under the guidance of the Team Lead. The role will be responsible for following established processes, maintaining GMP-compliant documentation, and supporting troubleshooting and process improvement activities.

Key Responsibilities

• Execute oligonucleotide manufacturing activities as per approved SOPs, batch records, and established processes.
• Perform solid-phase oligonucleotide synthesis, deprotection, cleavage, purification, and formulation activities under the guidance of the Team Lead.
• Operate and monitor manufacturing equipment used for oligonucleotide synthesis and purification.
• Follow defined process parameters and instructions to ensure consistent yield, purity, and reproducibility.
• Maintain accurate and timely batch records, equipment logs, process records, and other manufacturing documentation.
• Follow GMP, QMS, safety, and good documentation practices during all manufacturing activities.
• Assist the Team Lead in process optimization, scale-up, technology transfer, and implementation of manufacturing processes.
• Support troubleshooting of synthesis, purification, and other process-related issues and escalate deviations or abnormalities to the Team Lead.
• Coordinate with Quality Control, Quality Assurance, R&D, Validation, and other relevant teams as required for routine manufacturing activities.
• Support sampling and submission of process samples for analytical testing and assist in reviewing analytical results related to manufacturing batches.
• Participate in cleaning, equipment maintenance, calibration, and readiness activities as required.
• Support preparation and execution of validation, qualification, and process improvement activities.
• Identify opportunities for improving process efficiency, yield, quality, and safety and communicate suggestions to the Team Lead.
• Ensure compliance with approved SOPs, safety procedures, and GMP requirements at all times.
• Maintain a clean, organized, and safe manufacturing work area.

Required Skills & Knowledge

• Good understanding of organic chemistry and basic principles of oligonucleotide chemistry.
• Knowledge or practical exposure to oligonucleotide synthesis and purification will be an advantage.
• Basic understanding of GMP, QMS, documentation practices, and good laboratory/manufacturing practices.
• Ability to follow SOPs, batch records, and defined manufacturing procedures accurately.
• Good analytical and problem-solving skills.
• Ability to identify process abnormalities and escalate issues appropriately.
• Good written and verbal communication skills.
• Ability to work effectively as part of a cross-functional manufacturing team.
• Willingness to work in a manufacturing environment and follow applicable shift requirements, if required.