Job Description

More than 380! That\'s the number of associates in our Singapore Large Molecules division to support the making of medicines for our patients worldwide.

As a Technical Transfer Lead, you are responsible for technology transfer activities at site level within, inbound and outbound, including any scale-up or other process adaptations. You will also lead technical transfer project team at site and liaises efficiently with involved functions (e.g., Technical Development, Supply Chain, Production Unit, Quality Control, HSE, other sites).

Key Responsibilities

• Act as SPOC on site for technical transfer. Perform technical feasibility assessment for supply point decision in close collaboration with other stakeholders. Determine scope / design of technical batches for transfer.
• Provide input into overall project strategy and plans including timelines, initiate local change control in system on site, and ensure approval and closure.
• Establish site project plan, elaborate scientifically sound technical strategies with project team, develop contingency plans, identify hurdles and propose solutions. Assess and plan site resource needs and get management approval for the overall project costs (e.g., FTEs, batch costs, investments and external costs), strategies, and timelines.
• Form and lead site project team - set priorities for project and project team meetings, coordinate project team activities, ensure that Novartis guidelines and HSE and GMP guidelines are met.
• Ensure that project tracking documentation/tools are up-dated according to plan and ensure timely availability of technical documentation according to Novartis guidelines. Write Manufacturing Process Transfer Documents (protocol, report).
• Review key documents and coordinate input for relevant registration documents for accuracy and completeness (as appropriate).
• Liaise with global project manager, giving site (CMC team for development transfers) and site functions. Ensure knowledge transfer from giving site to receiving site including to operators.
• Establishes local procedures & templates for technical transfer. Ensure site readiness for campaign start-up. Contribute to process improvement and optimization for product transfers.
• Contribute to inspection (Pre-Approval Inspection PAI) readiness and ensure site readiness for campaign start-up. Establishes local procedures & templates for technical transfer.

Minimum requirements

• BSc. in Pharmacy, Pharmaceutical Technology, Chemistry, or equivalent scientific / engineering degree. Desirable MSc. or equivalent experience.
• Minimum 8 - 10 years of relevant experience in pharmaceutical manufacturing with knowledge of monoclonal antibody or cell culture; comprehensive know how in pharmaceutical technology, project management experience.
• Preferably, 5 years of experience in MS&T function.
• Ability to collaborate with others and work in a team.

Why consider Novartis?
236 million lives were touched by Novartis medicines in 2022, and while we\'re proud of this, we know there is so much more we could do to help improve and
extend people\'s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse,
equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what\'s possible, when we
collaborate with courage to aggressively and ambitiously tackle the world\'s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do at Novartis!

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

Functional Area

Technical Operations

Division

Operations

Business Unit

CONTRACT MANUFACTURING

Employment Type

Regular

Commitment to Diversity & Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Shift Work

No

Early Talent

No

Novartis