Senior Process Expert - Bioprocess (d/f/m)

Job Description Summary

Job Description

As announced in December 2023, we started construction of one of the largest Biotech Large Scale production centers in Europe, located at Lendava, Slovenia. Operations will start in late 2026. Become part of this great story and team, excellent opportunity to contribute to the success of the project with your knowledge and experiences!

As Senior Process Expert (d/f/m)  you will be responsible for providing advanced technical support for the production of biological active substances (Bioprocess), mastering and optimizing complex production processes, and managing advanced process technologies and products. This also includes participating in continuous quality and productivity improvement, in accordance with current GMP, SOPs, and applicable guidelines and functional standards (e.g., ZVO), as well as supporting the smooth operation of production with the goal of improving quality and compliance.

Join us as a Founder of our ‘new’ Sandoz and Lek! 

Your key responsibilities:

Your responsibilities include, but not limited to:

• Provide front line expert support for most complex issues and challenges, related to processes and production of biosimilars

• Act as Subject Matter Expert (SME) for specific techniques, products or technical processes during the production of biosimilars

• Coordinate and ensure the completion of all production operations on time, in accordance with the documentation and in compliance with GMP

• Ensure on time shop floor support as an expert on technical problems and ensuring that appropriate immediate corrective actions are implemented

• Monitor the most complex processes, identify possible trends and ensure timely interventions in the event of observed negative trends

• Ensure that all of the most complex production documents, project timelines and/or validations are systematically and timely up to date for the need of regular production, in compliance with GMP

• Transfer of information and increase awareness of production teams following problems or modifications having a technical, quality or HSE impact

• If nominated, carry out trainings, including delivering state-of-the-art solutions and new scientific findings

What you will bring to the role:

• BSc./MSc degree in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy
  or equivalent scientific degree.

• Desirable MSc. or equivalent experience of the production of biosimilars

• Fluent in English and proficient in site local language

• Knowledge of Microsoft Office

• Minimum 5 year experience in process support role on the shop floor of
  manufacturing and/or quality.

• Process understanding (Pharma biosimilars, GMP, Regulatory aspects).

You’ll receive:

Employment at the most reputable employer in Slovenia offers Competitive salary, Annual bonus, Flexible working schedule, tailored to your needs, possibility to work from home, Pension scheme, Employee Recognition Scheme, Expanded program for the promotion of health in the field of physical, mental and social well-being (Energized for Life), Unlimited learning and development opportunities. 

Possible job locations: Slovenia (Ljubljana) 

We offer permanent contract with 6-month of probation period. You are kindly invited to submit your application in English language, including CV, by 06.12.2024.

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!

The future is ours to shape!

Commitment to Diversity & Inclusion:

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

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

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Skills Desired