Manufacturing Technologist (Port Elizabeth) at Aspen Pharma Group

Overview

• To perform technology transfer and scale up of new products into the Aspen SA Operation (Pty) Ltd manufacturing facilities. The main focus will be on (but not limited to) solid dosage forms.
• Provides technical / scientific support for internal and external technology transfer of manufacturing processes. Troubleshoots problems encountered during tech transfer/process optimization during product transfer.

Responsibilities

Planning and project support

• New product introduction assessment
• Technical feasibility assessments and manufacturing gap analysis of products and processes
• Draft preliminary batch manufacturing instructions and process flow for product costing.
• Draft Technology transfer protocols, project plans and timelines and prepare proposals and status reports
• Compile technical documents that comply with local and international regulatory guidelines
• Identify project issues and recommend methods for resolution 

Project management

Support aspects of tech transfer projects, including:

• Feasibility and risk assessment
• Protocols and Planning
• Trial and validation batch manufacturing
• Execution and tracking
• Collaboration / assistance with cross-functional teams, including for example, MSAT, regulatory, SVP projects according to operational requirements 

Manufacturing science, technology troubleshooting

• Advise and consult on recommended changes to production processes in conjunction with MSAT team
• Assist in solving capacity problems within the factory
• Review any changes in the manufacturing process before implementation
• Good understanding of Quality by Design concepts
• Perform developmental experiments by employing Design of Experiments 
• Prepare Quality by Design reports

Risk management and process validation

• Conduct feasibility and risk assessments
• Ensure that project planning encompasses quality, risk and process validation aspects
• Ensure data integrity and regulatory compliance throughout tech transfer processes
• Generate Process Validation Protocols and Results Records.
• Assist the MSAT team with manufacture of process validation batches.
• Knowledge transfer of new manufacturing process to operators and production pharmacists
• Review and approve the Process Validation Report
• Recommend effective process changes relating to the validation report in conjunction with MSAT.

Requirements

Skills Required

Background/experience

• 4 to 6 years’ experience, with at least two years in a pharmaceutical manufacturing environment, or 1 to 2 years experience in relevant manufacturing environment
• Bachelor’s degree in Pharmacy, Engineering or similar

Specific job skills

• Knowledge of Pharmaceutical technical issues, manufacturing processes and operations environment
• Knowledge of validation, regulatory affairs, R&D, and new product transfer
• Knowledge of local and international  pharma guidelines

Competencies

• Offering Insights
• Investigating Possibilities
• Innovative Thinking
• Technical/scientific report writing
• Data analysis