Technical Transfer Lead

Novartis; Selangor; On-site; MYR 120,000 - 180,000; Full time

Job summary

A leading pharmaceutical company is seeking a Technical Transfer Lead responsible for managing technology transfer activities at the site level. This role involves leading project teams, ensuring compliance with quality standards, and optimizing processes for product transfers. Ideal candidates will have significant experience in pharmaceutical manufacturing and strong project management skills.

Qualifications

• Minimum 8 years of relevant experience in pharmaceutical manufacturing.
• Comprehensive knowledge in pharmaceutical technology and project management.
• Fluent in English and proficient in the local language.

Responsibilities

• Lead technical transfer project teams and manage local change controls.
• Ensure availability of technical documentation for validation.
• Contribute to process improvements and optimization for product transfers.

Skills

Project Management

Pharmaceutical Technology

Process Improvement

Education

BSc in Pharmacy

MSc or equivalent experience

Job description

Summary

The Technical Transfer Lead is responsible for technology transfer activities at the site level (including inbound and outbound transfers), as well as any scale-up or process adaptations.

The role involves leading the technical transfer project team at the site and liaising effectively with involved functions such as Technical Development, Supply Chain, Production, Quality Control, HSE, and other sites.

About The Role

Stewardship – for transfer assigned

• Review and update Quality Risk Assessment (QRA) prior to transfer and validation, and adapt control strategies if needed.
• Review first APQR after transfer to ensure product performance.

Validation – for transfer assigned

• Ensure availability of all relevant technical information and documentation for validation.
• Define pre-validation and validation strategies, including process, cleaning, packaging, and supportive studies (e.g., hold times). Coordinate technical, regulatory, and validation batches at the site.
• Support Validation Lead/Expert in creating validation protocols and reports.
• Review validation protocols and reports.
• Initiate monitoring and Ongoing Process Verification phases.

Launch & Transfer

• Act as the SPOC on site for technical transfer.
• Perform technical feasibility assessments for supply point decisions, collaborating with stakeholders, and determining the scope/design of technical batches.
• Provide input into project strategies and timelines.
• Manage local change controls and ensure approval and closure.
• Establish site project plans, develop technical strategies, contingency plans, and resource needs, securing management approval for costs and timelines.
• Form and lead the site project team, set priorities, coordinate activities, and ensure compliance with guidelines.
• Maintain up-to-date project tracking documentation and ensure timely technical documentation and registration inputs.
• Liaise with global project managers and site functions, ensuring knowledge transfer and site readiness.
• Contribute to inspection readiness and establish procedures and templates for technical transfer.

Manufacturing Excellence

• Contribute to process improvements and optimization for product transfers.

Training

• Own the training curriculum for the role and direct reports.

Novartis Manufacturing Manual

• Support the implementation of Novartis Manufacturing Manual principle 3.

Travel Required

• Travel to Singapore at least 1-2 times per month.

Relevant Experience

• Minimum 8 years of relevant experience in pharmaceutical manufacturing, with comprehensive knowledge in pharmaceutical technology and project management.

Education & Qualification

• BSc in Pharmacy, Pharmaceutical Technology, Chemistry, or equivalent; MSc or equivalent experience preferred.

Languages

• Fluent in English and proficient in the local language.

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