Type your keywords in the search box above

Emulsion Specialist

ROLE PURPOSE:

To provide expert technical input into manufacturing processes of new and/or existing Aspen Pharmacare products within the SVP manufacturing facilities of Aspen with a key focus on emulsion products and associated processes and equipment.

RESPONSIBILITIES:

ASSESSING

  • Provide detailed assessment of processes to be developed and transferred focusing on compounding and terminal sterilization of emulsion products
  • Review new and current product design and recommending revisions of product and process specifications
  • Analyzing production limitations and standards through coordination with manufacturing and engineering
  • Identification of risks in transferring and / or developing the processes with appropriate risk mitigation strategies

TECHNICAL TRANSFER & EVALUATION

  • Assess new manufacturing processes for incorporation and implementation into Aspen providing detailed gap assessments from sending site processes with solutions
  • Provide technical input in new product introduction risk assessments
  • Technical Evaluation of Equipment, required batch sizes and Technical Ability to manufacture a product
  • Ensure a sound understanding of the product’s critical process parameters and critical quality attributes in order to ensure a successful technology transfer
  • Monitor the manufacture of development / validation / trial batches in conjunction with production in order to gain a thorough understanding of the process and formulation variables influencing a successful batch outcome

PROJECT EXECUTION

  • Design processes and operational procedures according to product specifications
  • Proposing and executing small scale studies and experiments to show confidence in proposed processes
  • Drive improvement efforts through Statistical Process Control and problem solving methodologies such as Design of Experiments
  • Analyse production process controls incl. statistical process control and capability, Cpk, assessment with the intention of detecting improvement or maintaining a high level of performance
  • Identify process critical control points and evaluate critical limits through a QbD approach

TROUBLESHOOTING

  • Investigate and recommend effective solutions to issues arising within production
  • Solving of problems through analytical processes
  • Provide ongoing Technical Support to relevant departments
  • Drive process improvement studies and projects where indicated 

CHANGE MANAGEMENT

  • Identify process improvements for existing products; ensure these are investigated, implemented and validated
  • Apply a science and risk-based approach to product and processing understanding within a Quality by Design (QbD) framework
  • Review and advise on any changes in the manufacturing process prior to implementation
  • Manage the implementation of identified process changes within the manufacturing area
  • Keep up-to-date with new technology developments
  • Keep up-to-date with industry advances, with specific focus on sterile application
  • Advise and consult on recommended changes to production processes to optimize production yields
  • Ensure necessary trial batches are prepared to accommodate the recommended changes
  • Investigate and recommend effective solutions to issues arising within production

 

 

Job requirements: 

EDUCATIONAL AND EXPERIENCE REQUIREMENTS:

  • Relevant tertiary qualification in Pharmacy, Engineering, and/ or the relevant Sciences
  • Honours/ Masters qualification in Pharmacy, Engineering, and/ or the relevant Sciences will be an advantage
  • 3-5 years’ experience working in the pharmaceutical industry either in development, engineering, technical support, or production.
  • 1-2 years’ demonstrated Intravenous (injectable) product experience with a key focus on emulsion products and associated processes and equipment;
    • Track record indicating relevant GMP, aseptic, and sterile experience.
    • Experience in the following commercial scale technology platforms (processes and equipment); Formulation, High pressure homogenization and emulsification, Terminal sterilization (rotary sterilizers).
  • 1-2 years’ demonstrated knowledge/experience on the emulsion product associated processes and the critical control parameters and related key quality attributes, which includes;
    • Understanding of the essential parameters influencing emulsion integrity, particle size uniformity and sterility i.e. homogenization pressure and number of cycles, homogenization temperature, pH value and steam sterilization.
    • Thorough understanding of destabilization tendencies of emulsions.
    • Experience working with Anaesthetic products at a commercial scale will be advantageous.

KEY BEHAVIOURAL DIMENSIONS AND SKILLS:

  • Well-developed planning, problem solving, analytical and communication skills.
  • Attention to detail, accuracy and initiative should be demonstrated, as well as customer focus, and logical thinking.
  • Protocol and technical report writing skills.
  • Good problem solving skills.
  • Ensuring that analytical and test problems are handled efficiently and according to the laboratory quality policy.
  • Adherence to Standard Operation Procedures, Safety and Good Laboratory Practices requirements in the laboratory and related environments.

Reference Number: 

ESPE

Company: 

Aspen

City: 

Port Elizabeth

Country: 

ZA

Salary: 

Market Related

Job Type: 

fulltime

Industry: 

Pharmaceutical And Medical/Healthcare