336130BR
Jul 15, 2022
Slovenia

Job Description

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

As Analytical Science & Technology Manager (m/f/d) you are responsible for planning and undertaking analytical studies (development, verification, validation, and transfer of methods), stability studies or other supporting activities, as well as interpretation and reporting of results to provide timely and quality support to projects or processes (control, production and development).

Your key responsibilities:
• Define and implement business processes and Standard Operational Procedures necessary to maintain a robust AS&T Quality System within External Supply (e.g, data integrity, change management, maintenance of testing monographs).
• Supports analytical trouble shooting as needed.
• Act as project lead in cross-functional project teams.
• Supports the accountable Quality Assurance Manager to define and maintain the ESO Stability Program at Contract Manufacturing Organizations, ensuring it’s aligned with registration documentation and Health Authorities requirements.
• Interpretation of stability data, trends analyses, and providing scientifically sound conclusions for product shelf life assessments, storage conditions, packaging and transport categories. Provide corrective actions to address immerging stability issues.
• Support the External Supplier Qualification process.
• Support Tech Transfer assessments for analytical method transfers.

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:
• Higher university degree (e.g. Ph.D.) in Pharmacy, Biochemistry, Chemistry, or another related science.
• Fluent in English.
• 5 years’ experience in the pharmaceutical industry.
• 5 years’ experience in QC, method development, validation or stability testing of drug substance.
• Knowledgeable in cGMP, ICH guidelines, QA, regulatory requirements & risk management.
• Good leadership skills and experiences in leading project teams. Strong track record in project management.

Possible job locations: Slovenia (Ljubljana, Mengeš, Lendava, Prevalje)

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.

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 29th of July 2022.

Why Novartis?

More than 750 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!

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.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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 QUALITY
Slovenia
Ljubljana
Quality
Full Time
Regular
No
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336130BR

Analytical Science & Technology Manager (m/f/d)

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