Technical Transfer Lead - FWN
Responsible for technical transfer activities at site level, including scale up. Leads technical transfer project team at site and liaises efficiently with involved functions (e.g. Development, Validation, Supply Chain, Production, Quality Assurance, Quality Control, HSE, other sites).
New Product Transfers:
- Manages activities at site level for product transfers (process, technology, analytics, capacity, re-sources).
- Provides technical expertise together with other site experts.
- Defines and monitors project scope, budget, timing, and progress.
- Initiates change control per procedure(s) and ensures approval and closure.
- Writes manufacturing process transfer documents (protocol, report).
- Coordinates feasibility, regulatory, and validation batches at site.
- Ensures that all activities are performed to current standards of current Good Manufacturing Practices (cGMP), Health Safety Environment (HSE), Regulatory, etc.).
- Ensures Pre-Approval Inspection (PAI) readiness.
- Establish and monitor new product transfer
Key Performance Indicators (KPIs). Improvement on Product/Process:
- Supports continuous process and quality improvements.
- Manages technology transfer for scale-up, at site level.
- Initiates monitoring and Continuous Process Verification (CPV) phase.
- Own the Training Curriculum for assigned Job Profile and provide training and support to new associates joining related functions.
- Maintain assigned documentation and work area in inspection readiness level and provide necessary support in any internal or external audit.
- Technical transfer milestones achieved in time and in full, including schedule for registration and launches.
- Robust manufacturing process, delivering critical quality attributes, meeting cGMP standards.
- Completeness of Regulatory CMC dossier.
- Success rate during internal and external cGMP inspections and Pre-Approval Inspections (PAI).
- New product transfer Key Performance Indicators (KPIs).
- Adheres to project and Capital Appropriation Request (CAR) costs.
- Technical reports executed on time and with the right expectations.
- Supply chain success for product launches and for process improvement projects. EEO Statement The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Minimum requirements Bachelor's in Pharmacy, Pharmaceutical Technology, Chemistry or equivalent scientific or engineering degree.
- 7 years of relevant experience in pharmaceutical manufacturing; comprehensive know-how in pharmaceutical technology, project management experience.
Fluent in English
15 years of experience.
- Proven process understanding (Pharma, GMP, Regulatory aspects).
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