API Production Operator

KPA

EXPECTED OUTCOMES

Administration

• Participate in compiling the R&D budget.
• Execute assigned R&D projects to meet departmental deliverables within clearly defined timelines.
• Assist in project management tasks, such as timeline tracking, resource allocation, and progress reporting.

R&D facility/equipment management

• Assist with identifying facility/equipment needs and procurement thereof. 
• Routinely clean the R&D facility/equipment & practice good housekeeping.
• Perform routine facility/equipment checks to ensure R&D equipment/utilities are functional, calibrated and appropriately maintained and operated.
• Ensure proper functioning and maintenance of laboratory equipment.
• Identify and report any issues with equipment and assist in troubleshooting or coordinating repairs.
• Complete R&D facility/equipment checklists & logs.
• Supervise external contractors performing facility/equipment repairs. 

R&D resource management

• Conduct regular inventory checks and annual stock take counts.
• Assist with procurement of raw materials, packaging, consumables etc. including tracking & receiving orders.
• Assist with procurement & laundering of PPE.
• Collate and file all procurement records. 

R&D waste management

• Appropriately handle, segregate and store R&D waste.
• Ensure the R&D waste storage area is clean & organized.
• Complete waste logs. 
• Compile and/or collate all waste documents required for R&D waste collection. 

Research and analysis

• Conduct literature reviews to stay updated on the latest developments in the field of pharmaceuticals and active pharmaceutical ingredients.
• Stay abreast of research and emerging technologies that may impact the R&D activities.
• Assist in the analysis of experimental results using statistical methods and software tools.

Synthesis and process development

• Perform assigned activities required for the development and optimisation of synthetic routes.
• Participate in scaling up of laboratory processes to pilot and production scales.
• Collect, organise, and analyse experimental data using laboratory techniques and equipment.
• Participate in risk assessments, root cause analysis and implementation of change control & corrective/preventive actions associated with R&D activities. 

Analytical techniques

• Handle and prepare samples for analysis, ensuring accuracy and precision in measurements.
• Follow established protocols for sample preparation and storage.
• Assist with characterising the structure, purity, and quality of synthesised compounds.
• Assist with validation of analytical methods to monitor and quantifying key parameters.
• Generate and maintain a library of reference material, generate accompanying analysis and characterisation reports.
• Participate in forced degradation studies.
• Assist with compiling documentation/reports for and monitoring of R&D stability studies.
• Address any issues related to analytical methods and collaborate with analytical teams to resolve challenges.

Documentation

• Compile and organise R&D documents including SOPs, protocols, etc.
• Maintain detailed and accurate records of experiments, procedures, and results in laboratory notebooks or electronic databases.
• Prepare detailed technical reports that summarise research methodologies, findings, and outcomes of assigned activities.
• Ensure that R&D documents/records created meet the standards required for regulatory submissions.
• Assist with the preparation & of patent applications.
• File & archive R&D documents. 

Reference standards

• Manufacture required reference standards.
• Document/create reference standard production records. 

Collaborate with relevant stakeholders

• Collaborate with cross-functional teams and actively participate in technology transfer.
• Collaborate with the OHS Officer to identify hazards, perform associated risk assessments and identify PPE requirements. 

Training & ongoing development

• Participate in safety training programmes and adhere to all safety guidelines and regulations.
• Maintain R&D training files.
• Actively pursue opportunities for professional development, attend conferences, workshops, and training sessions to stay informed about the latest advancements in organic chemistry, pharmaceuticals, and related fields.