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Job Title and Reporting Structure
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JOB TITLE
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API Production Operator
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FUNCTIONAL REPORT
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R&D Chemist
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DIRECT REPORTS
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None
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Mission of the Job
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To actively support and contribute to the various facets of the R&D department, by executing tasks assigned by and working under the supervision the R&D Chemist.
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Key Responsibility Areas
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KPA
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EXPECTED OUTCOMES
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Administration
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- 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.
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R&D facility/equipment management
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- 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.
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R&D resource management
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- 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.
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R&D waste management
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- 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.
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Research and analysis
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- 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.
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Synthesis and process development
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- 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.
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Analytical techniques
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- 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.
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Documentation
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- 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.
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Reference standards
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- Manufacture required reference standards.
- Document/create reference standard production records.
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Collaborate with relevant stakeholders
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- 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.
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Training & ongoing development
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- 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.
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Qualifications
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- Bachelor of Science degree in relevant chemistry field or NQF 10
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registration with a SAQA certified professional body preferred.
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The minimum requirement is a BSc in a relevant chemistry field, but preference will be given to applicants with an Honours or Master’s degree.
- Min 3 years’ experience in an R&D environment.
- Experience in a pharmaceutical manufacturing environment / cGMP certification advantageous.
- Prior experience in R&D, particularly in a pharmaceutical or fine chemical environment, will be advantageous.
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Skills and Abilities
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- Effective verbal and written communication (proficient in MS Office Suite)
- Ability to execute multiple projects according to strict deadlines.
- Take instruction and work independently with minimal supervision.
- Organised with excellent attention to detail.
- Analytical and problem-solving skills
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