Technical Steward, Devices and Combination Products (m/f/d)

Oct 12, 2021

Job Description

9 years in a row! Lek is among the most reputable employers in Slovenia.

As a Technical Steward (Devices and Combination Products) (m/f/d) you will be providing technical direction and support for combination products throughout the product life cycle from late stage development, through technical transfer, scale up, life cycle maintenance and removal from the market.

Your key responsibilities:
• Owns the knowledge of specific medical device manufacturing process technologies, locally, including any pilot scale, scale up or down, and Design of Experiments.
• Provide technical leadership of Medical Device & Combination Products and validation across late stages of development through product end of life.
• Subject Matter Expert (SME) for specific Technology Platform or medical device processes following process product/process transfer or handover from launch to commercial production.
• Lead the Standardisation and Packaging Specification Reduction program for the Devices and Combination Products area
• Spearhead operational excellence strategies to improve combination product quality, reliability and reduce risk.
• Ensure the compliance with applicable GMP, regulatory, ISO and other professional requirements for combination products throughout life cycle.
• Responsible for drug/device combination stewardship and for CMC support of regulatory filings for combination product(s).
• Acts as the Single Point Of Contact for the interface with global MS&T network and with technical development organization.

Diversity & Inclusion / EEO

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

Minimum Requirements

What you’ll bring to the role:
• Bachelors of Science, Master’s or Ph.D. degree in the fields of Mechanical Engineering, Chemical Engineering, or a similar field is required.
• At least 10 years of hands-on experience in combination products development or operations preferably in a pharmaceutical or biotech company, in GMP manufacturing relevant to the specialist area of expertise.
• Fluent in English language.
• Proven process understanding (Pharma, GMP, Regulatory aspects).
• Strong technical writing and oral communication skills are required.
• Deep understanding of device related ISO standards and global regulatory requirements/guidance documents.
• Ability to be flexible and adapt to change and ability to work in an ambiguous environment.

Desirable Requirements:
• Previous combination product project management experience from early feasibility to commercialization.

You’ll receive:
Flexible working schedule, competitive compensation package, annual bonus, possibility to work from home, pension scheme, employee recognition scheme, sports club membership, employment at Top SI employer, learning and development opportunities and much more.
Possible job locations: Slovenia, Austria.

We offer permanent employment, with a 6 months probation period.

You are kindly invited to submit your application in Slovene and English language, including CV on our website by 26th of October 2021.

Why Novartis?
769 million lives were touched by Novartis medicines in 2020, 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!

Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons.

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.
Novartis Technical Operations
Technical Operations
Full Time
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Technical Steward, Devices and Combination Products (m/f/d)

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