Project Lead Biopharma (d/f/m)

Job Description

As a Project Lead Biopharma, you'll orchestrate Process and Engineering teams, aligning technical solutions and strategically managing investments with a focus on quality, sustainability, and safety. Drive successful startup through timely equipment qualifications, top-tier team building, and seamless product transfers, culminating in flawless GMP inspections. Build a high-performing team to efficiently introduce new materials, establishing a plant poised for operational excellence and market leadership.

Your Key Responsibilities

Your responsibilities include, but not limited to:

• Synergy: Ensure optimal collaboration and synergistic operation between different units to ensure timely implementation of project activities for the construction of the new plant.
• Technology: Ensure the most optimal selection of a single-use technology provider and assemble equipment and materials for the needs of flexible and state-of-the-art production of biopharmaceutical active ingredients.
• Strategy: Manage the short-term and long-term strategy for CAPEX and OPEX projects.
• Quality: Coordinate quality requirements (GMO, GMP), occupational safety, sustainable development and logistics during the construction of the plant and seek optimal solutions.
• Qualifications: Ensure timely IQ, OQ and PQ qualifications, oversee the implementation of all qualifications.
• Personnel: Coordinate the timely onboarding of managers and employees in key functions for the start-up of the plant (Production, MS&T, Quality, SCM, PM).
• Documentation: Coordinate GMP documents that must be issued before the start-up of the plant by Production, MS&T, Quality, Engineering.
• Startup: Plan product transfers to the plant, develop a production plan and ensure timely GMO, GMP inspections for the start-up of the plant.
  
  

What You Will Bring To The Role

• University education in the field of natural sciences, pharmacy, chemical engineering, pharmaceutical technology or another relevant field. Additional education in economics, lean management or business excellence is preferred.
• Active knowledge of the English language.
• Knowledge of Microsoft Office tools.
• Minimum of 10 years of experience in leadership positions in pharmaceutical production or development.
• A minimum of 5 years of experience with "single-use" process equipment and materials used in the production of biological drug substances.
• Experience in leading multi-functional, international teams, good cooperation with key suppliers in solving challenges.
• Experience in investment projects, start-up of plants, setting up of GMP production in biopharmaceuticals is desirable.
• Good knowledge of GMP, and HSE requirements in biopharmaceutical production.
• Broad interdisciplinary knowledge with a strong focus on finance and clients.
  
  

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 a permanent contract with a 6-month of probation period. You are kindly invited to submit your application in the English language, including your CV, by March 2nd, 2025.

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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