339762BR
May 16, 2022
Austria

Job Description

Technical Transfer Operations Lead (f/m/d), Global Drug Development - Schaftenau, Austria / Basel, Switzerland

150! That’s the number of GDPD projects in development, 100+ medical devices and combination products. This global role has been built to optimize and harmonize device and combination product transfer processes as well as lead LCM of commercial device and combination products.

Your key responsibilities:
• Provide expertise from the combination product/medical device platform point of view for strategical, process, technical, and e-systems related topics during device development stages, commercialization as well as for commercial products
• Establish an aligned technical transfer strategy for GDPD with NTO and harmonize cross-site manufacturing transfers from development to site level
• Establish and uphold aligned template based documentation for design transfers to NTO
• Coordinate development support of product maintenance operations for NTO as a customer and manage teams to implement changes concerning the medical device platform
• Support the Transfer Team lead in Launch Site Decisions and in technical launch activities for assembly and packaging at involved sites and is a member of the GDPD Device Development subteam
• Supports the manufacturing representative during device development stages (design control) and in the packaging design process for the GDPD product portfolio.


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:
Essential:
• PhD, Dipl. Ing. in Mechanical Engineering or Pharmaceutical Technology
• Minimum 5 years professional experience in Pharmaceutical Manufacturing (preferably assembly & packaging) with fundamental understanding of standard device/packaging analytical testing. Solid experience in reviewing and writing technical reports
• Thorough understanding of product processes and strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities.
• Knowledge in design control, documentation, risk management and processes such as DMR (Device Master Record), DHF (Design History File), pFMEA, Design Verification, and URS (User Requirement Specifications).
• Knowledge of 21 CFR part 210/211, 21 CFR part 4/820 and ISO 13485, ISTA, ASTM and EMA medical device directive.
• Strong Project management skills. Strong communication and intercultural skills with ability to work in a global matrix environment.
• Fluent in English, German is a plus


Why 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 here at Novartis!


In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development options as well as worldwide career opportunities within the Novartis group.
In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is € 52.204,04/year (on a full time basis). In most cases, the actual salary will be higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies
We are open for part-time and job sharing models and support flexible and remote working where possible.


Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Global Drug Development
TECHNICAL R & D GDD
Austria
Schaftenau
Switzerland
Research & Development
Full Time
Regular
No
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339762BR

Technical Transfer Operations Lead

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