Senior Process Expert - DSP  (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 - DSP  (d/f/m)  you will be responsible for the front line complex expert support for all process-specific issues to production within one or more complex production steps, to ensure execution of complex processes on-time, continuously improving in quality and productivity, performed in compliance to cGMPs, SOPs and applicable guidelines and functional standards (e.g. HSE...). You will support smooth operation of production, with the aim of improving quality and compliance and you will be responsible for upgrading and transfer of expertise, assessment and implementation of new technologies, and contribution to the development process optimization

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

Your key responsibilities:

Your responsibilities include, but not limited to:

• Providing expert support for the most complex questions and challenges related to processes and the production of biological drugs.

• Serving as a Subject Matter Expert (SME) for specific techniques, products, or technological processes in the production of biological drugs.

• Coordinating and ensuring the timely completion of all production procedures in accordance with documentation and Good Manufacturing Practice (GMP) regulations.

• Providing timely professional support to production in case of technical issues and ensuring the immediate implementation of appropriate corrective actions.

• Monitoring the most complex processes, identifying potential trends, and taking timely action upon observing negative trends.

• Ensuring systematic and timely updating of the most complex production documentation required for regular production, project timelines, and/or validations in accordance with GMP requirements.

• Ensuring the transfer of information and raising awareness among production teams in the event of challenges or changes that impact technical factors, quality, or EHS.

• Conducting training sessions and educational activities when appointed, including transferring the latest 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 6.12.2024. 

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

#Sandoz

Skills Desired