Job Description

Overview

• Provide technical / scientific support for internal and external technology transfer of manufacturing processes.
• Implement process validation activities and post-transfer support.
• Trouble shoot problems encountered during tech transfer / process optimization / commercial manufacture.
• Supports continuous improvement.

Responsibilities
Planning and project support

• Research and report on solutions to improve tracking, planning and collaboration.
• New product introduction assessment
• Technical evaluation of products and processes
• Draft transfer protocols, project plans and timelines and prepare proposals and status reports.
• Compile technical documents that comply with local and international regulatory guidelines.
• Support technology transfer team activities and projects.
• Identify project issues and recommend methods for resolution.

Project management

• Manage aspects of tech transfer projects, including:
• Feasibility and risk assessment
• Planning
• Trial and validation batch manufacturing
• Execution and tracking.

Manufacturing science, technology troubleshooting

• Provide planned and unplanned production support.
• Troubleshoot process / product problems.
• Guide during process changes, process optimization including API/IPI source changes.
• Provide manufacturing science & technical support for deviations, CAPAs, OOSs and technical complaints

Risk management and process validation

• Conduct feasibility and risk assessments.
• Ensure that project planning encompasses quality, risk and process validation aspects.
• Ensure regulatory compliance throughout tech transfer processes.
• Support investigations associated with tech transfer activities.
• Carry out Process Qualification (PQ) and Continued Process Verification (CPV) activities to validate transferred processes

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
• Bachelors 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