About the Role

　　Location: Mengeš #LI-Hybrid

　　We are seeking a highly motivated product steward to join MS&T team as we expand our manufacturing capabilities for the production of biologics. Our unique approach to single-use technology allows us to produce high-quality biological drugs substances with unparalleled efficiency. Our state-of-the-art technology and processes, a wide range of biological molecules, engaged and highly motivated teams committed to improve people's lives make us a factory of the future, and we are eager to welcome a talented individual to our team.

　　As a Product Steward I (m/f/d) you own the process knowledge of the product(s) assigned throughout the lifecycle, supporting manufacturing process transfers and GMP production. With oversight on process capability, through data trending and statistical analysis you will ensure that our manufacturing process(es) are robust, in continued state of validation and continuously improving. You will prepare, manage and execute product lifecycle related activities on time and with available resources, in accordance with cGMP, internal standards, and business goals.

　　The ideal candidate for this position will possess a strong analytical and quality mindset, broad knowledge of biopharmaceuticals, and drive for constant improvement and growth. If you are passionate about biopharmaceuticals, striving for improvement of people's lives and interested in being a part of a team that is leading the way in the industry, we encourage you to apply today.

　　Key Responsibilities:

　　• Maintains the oversight and knowledge for entire manufacturing process performed on site and throughout the entire commercial lifecycle, since transfer from development to date, including life cycle management activities.

　　• Contributes, creates, reviews and maintains a product specific documents, e.g. Quality Risk Analysis (QRAs), control strategy, validation and ongoing process verification (OPV) documentation, and APQR.

　　• Monitors processes using statistical analysis and conducting regular product specific data trending, evaluates process performance, detects issues, and ensures implementation of CAPAs.

　　• Ensures inspection readiness for all process related aspects of assigned products.

　　• Leads / supports root cause investigation of process failures, initiates and leads product improvement projects, involving cross-functional teams.

　　• Assesses the impact of technical changes on product, process, process validation status, registration documentation, technical feasibility, resources and business risk and proposes implementation strategy.

　　• Contributes to registration strategy and supports registration activities.

　　Diversity & Inclusion / EEO

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

　　Role Requirements

　　Essential Requirements:

　　• BSc. in Chemistry, Pharmacy, Biotechnology, Pharmaceutical Technology or other science degree. Desirable MsC / PhD in the above or equivalent.

　　• Minimum 5 years experience in pharmaceutical manufacturing, GMP manufacturing, technical development or quality or 8 years in comparable highly regulated industry.

　　• Functional knowledge of English.

　　• Proven understanding of quality systems and regulatory requirements across multiple health authorities.

　　• Expert in reviewing and writing technical reports.

　　• Good communication skils, proactive behaviour, result-driven.

　　Desirable Requirements:

　　• Proven project management experience in a cross-functional environment.

　　• Knowledge of statistical tools.

　　• Good management with different stakeholders.

　　• Ability to operate in a global environment.

　　We offer a permanent employment with 6 monthsof probation period.

　　You are kindly invited to submit your application in English language, including CV by 5th of January 2024.

　　Why Novartis?

　　Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn morehere: https://www.novartis.com/about/strategy/people-and-culture

　　You'll receive:

　　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), employment at Top SI Employer, Unlimited learning and development opportunities.

　　Commitment to Diversity and Inclusion:

　　Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

　　Join our Novartis Network:

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

　　Division

　　Operations

　　Business Unit

　　LARGE MOLECULES

　　Location

　　Slovenia

　　Site

　　Menges

　　Company / Legal Entity

　　NVS Farmacevtska Proi. doo

　　Functional Area

　　Technical Operations

　　Job Type

　　Full Time

　　Employment Type

　　Regular

　　Shift Work

　　No