Process Expert I (d/f/m)

Job Description Summary

Job Description

Sandoz, of which Lek is also a part, is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.

Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz and Lek associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.

As a Process Expert I you will provide front line expert support for all process-specific issues to production within one or more production steps, to ensure execution of processes on-time, continuously improving in quality and productivity, performed in compliance to cGMPs, SOPs and applicable guidelines and functional standards (e.g. HSE...).

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 complex issues and challenges, related to processes and production.

• Act as Subject Matter Expert (SME) for specific techniques, products or technical processes related to cell banking.

• Definition of operations, high level process description, process flows for cell banking

• Ensure GMP compliant IPC, QC and release testing at CROs.

• Preparation of SOPs, working instructions, master records in compliance with GMP requirements.

• Support selection and implementation of consumables, raw materials and equipment for cell banking

• Knowledge transfer and mentoring of associates.

• Lead validations, revalidations / qualifications and annual reviews, in accordance with deadlines and current regulations.

• Provide risk / gap assessments, determine effectiveness of related corrective actions.

• Collaborate with MS&T Experts regarding the definition of URS and execution of qualification and validation.

• Comply with and enforce health, safety and environment rules and guidelines (HSE).

• Promote and improve the Quality culture in collaboration with Quality Assurance.

• Ensure overall inspection and internal audits readiness for area of responsibility.

• Lead or provide operational support to teams during technology / product transfers in production.

What you will bring to the role:

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

• Minimum 3 year experience in process support role on the shop floor of GMP manufacturing and/or QA/QC.

• Proven process understanding (Pharma, GMP, Regulatory aspects).

• Fluent in English, local language skills are desirable but not mandatory.

• Knowledge of Microsoft Office.

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 (Lendava) 

We offer temporary contract (1 year) with 6-month of probation period, with the possibility of extension. You are kindly invited to submit your application in English language, including CV, by 31.12.2024.

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