342967BR
13. Juli 2022
Slovenia

Job Description

28,000 associates of more than 100 nationalities deliver high quality and affordable medicine on time, every time, safely and efficiently.

Your key responsibilities:
• Technical oversight of the apheresis processes. Maintain the knowledge and the history of the product process throughout the entire late-stage clinical and commercial lifecycle, since transfer from development to date.
• Support interaction with hospitals (e.g. product experience review meetings, deep dives, hospital apheresis quality performance) as a core member of the cross-functional team.
• Liaise with manufacturing network and Apheresis QA with focus to ensure and improve product process capability. Management of change controls related to apheresis material.
• Coordinate Trend Investigations on apheresis issues and generate Trend Investigation reports. Support investigations at manufacturing sites.
• Provide support during audits (e.g. hospital qualification audits, internal audits, inspections).
• Coordinate/ support/ lead apheresis related global projects and initiatives that drive continuous improvement and global alignment and lead technical projects to optimize interface between Novartis and hospitals.
• Global Coordination and maintenance of the Leukapheresis material requirements and Global process ownership for apheresis site qualification and oversight (Leukapheresis Manual(s), SOP/WP/FRM).
• Coordination of the Global Cell & Tissue Ops Training program to ensure that regional Cell Therapy Operations teams understands the technical and quality requirements for supply of cellular manufacturing starting material (Leukapheresis Material).

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 will bring to the role:
• University degree with an advanced degree in science preferred.
• 10+ years of GxP pharmaceutical experience or at least 5 years pharmaceutical experience and equivalent experience in GTP.
• Fluent in English.
• Track-record managing complex projects.
• Strong organizational, presentation and communication skills, with an ability to synthesize and simplify complex information and data.
• Flexibility to adapt to changing situations, ability to prioritize tasks according to objectives, and provide problem resolution while maintaining a quality mind-set putting patent needs as a top priority.
• Clinical trial and manufacturing operations experience desirable.

You’ll receive

Competitive salary, Annual bonus, Flexible working schedule, tailored to your needs, possibility to work from home, Pension scheme, Employee Recognition Scheme, Sports Club Membership, employment at Top SI Employer, Learning and development opportunities.

Possible job locations: Slovenia, Spain and Italy.

We offer permanent employment, with 6 months of probation period.

You are kindly invited to submit your application in English language, including CV by 27th of July 2022.

Why Novartis?

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!

Imagine what you could do here at Novartis!

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
SANDOZ
NTO CELL & GENE THERAPY
Slovenia
Ljubljana
Spain
Italy
Quality
Full Time
Regular
No
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342967BR

Apheresis Technical Steward (m/f/d)

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