Jun 15, 2022

Job Description

4 Right First Time successful Biotechnological NPI these past 4 years. This is our MS&T Team’s record. Join a site passionate to bring product with High Performance and Quality to the market, ensuring timely delivery and high quality products to all of our patients.

As the Senior Technical Transfer and Technology Lead, you will Lead Technical Transfer & Technology MS&T Team. This will include New Product introduction on site assessment and New Technology introduction with Cross function team support and global functions collaboration as well as ensuring efficient stakeholders management for RFT .

Key Responsibilities

• Lead MS&T Technical Transfer & Technology Team
• Act as SPOC on site for New Product Introduction assessment and new technology introduction.
• Collaborate with Supply and site project management to coordinate site assessment and identify best implementation approach.
• Together with your team, support Optimization and study to accelerate market access/Launch and Process state of the art implementation
• Together with your team support and coordinate with MS&T Laboratories for studies/DOE at lab, pilot or commercial scales for PV, optimization, troubleshooting or familiarization.
• 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.
• 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, timely availability of technical documentation according to Novartis guidelines. Write Manufacturing Process Transfer Documents (protocol, report).
• 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.
• Contribute to inspection (Pre Approval Inspection PAI) readiness.
• Ensure site readiness for campaign start-up and establishes local procedures & templates for technical transfer

Diversity & Inclusion / EEO

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

Minimum Requirements

What you’ll bring to the role:
• BSc. in Pharmacy, Pharmaceutical Technology, Chemistry or equivalent scientific 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, team management experience would be an advantage.

Why consider Novartis?
766 million lives were touched by Novartis medicines in 2021, 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!
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

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
Novartis Technical Operations
NTO Contract Manufacturing
Technical Operations
Full Time
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Senior Technical Transfer & Technology Lead

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