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Wildlife Pharmaceuticals - API Production Operator

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Role Summary

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.

Job Description

Job Title and Reporting Structure

JOB TITLE

API Production Operator

FUNCTIONAL REPORT

R&D Chemist

DIRECT REPORTS

None

 

 

Mission of the Job

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.

 

 

Key Responsibility Areas

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.

Qualifications

  • Bachelor of Science degree in relevant chemistry field or NQF 10

  • registration with a SAQA certified professional body preferred.

  • 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.
 

Skills and Abilities

  • 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

Additional Information

  • Working style: The successful applicant must be able to work independently with minimal supervision, take a practical and hands-on approach in the laboratory, and be energetic, since a large portion of the role will include laboratory and production work.
  • Competencies: Strong competence in technical reporting and documentation is essential. The applicant must also be well-versed in chemical safety and hazards.
  • Key duties:
    • Assisting in routine fine chemical production and process execution.
    • Supporting research and development activities, including experiment design, execution, and structured reporting.
    • Completing batch records, in-process testing, and basic analytical methods.

  • This is a great opportunity for both the production support responsibilities and the opportunity to contribute to new product development.

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