About the Role

　　Senior Technical Transfer Lead (f/m/d)

　　Drug Product Schaftenau - We are the biotechnology specialist within Novartis with decades of experience and comprehensive know-how in the entire spectrum of Biologics.

　　Join the Manufacturing Science and Technology team in Drug Product Schaftenau as Technical Transfer Lead and participate at the frontline in bringing highly innovative, high-quality pharmaceuticals to the patients.

　　You will lead technical transfer project teams at site and liaise efficiently with involved functions (e.g. Technical Development, Supply Chain, Production Unit, quality Control, Health, Safety & Environment, Contract Development & Manufacturing Organization platform, other sites.).

　　This role will work directly with the Manufacturing, Science & Technology team, and reports to the Head Manufacturing Science &Technology.

　　Your key responsibilities:

　　Your responsibilities include, but are not limited to:

　　• Responsible for technology transfer activities at site level (within, inbound and outbound), including any scale-up or other process adaptations

　　• Drives compounding and filling tech transfers as well as assembly and packaging transfers

　　• Leads technical transfer project team at site and liaises efficiently with involved functions (e.g. Technical Development, Supply Chain, LCM, Production Unit, Quality Control, HSE, other sites - incl NOCCs.)

　　• Contributes to registration strategy and support registration activities

　　• Initiates Change Requests as needed for TT, drives process to create material numbers, introduction of new materials, etc

　　• Supports project planning as well as reporting in local boards / meetings• Ensure timely availability of technical documentation according to Novartis guidelines. Write Manufacturing Process Transfer Documents (protocol, report).

　　• Establish local procedures & templates for technical transfers and contribute to process improvements and optimization for product transfers.

　　Diversity & Inclusion / EEO

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

　　Role Requirements

　　What you'll bring to the role:

　　Essential:

　　• A minimum of 5 years of relevant experience in pharmaceutical manufacturing, technical transfer management / manufacturing science and technology / technical development / quality

　　• University degree (MSc. or PhD) in Biology, Biochemistry, Biotechnology, Biochemical Engineering, or equivalent experience

　　• Solid understanding / insights into DP production and/or assembly & packaging activities

　　• Strong experience in Project Management, good organization and planning skills

　　• Understanding and oversight of relevant regulatory requirements, e.g. GMPs, ICH Q-guidelines.

　　• Problem-solving and idea generation skills to apply smart risk management and decision-making strategies

　　• Excellent relationship / external stakeholder management skills

　　• Ability to work in a matrix organization

　　• Self-driven, highly autonomous workstyle

　　• Excellent written and verbal communication/presentation skills

　　• Fluent in English, German desirable

　　Why Novartis?

　　236 million lives were touched by Novartis medicines in 2022, 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!

　　In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development options as well as worldwide career opportunities within the Novartis group. In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is €73,112.90/year (on a full-time basis). The actual salary will be significantly higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies.

　　We are open for part-time and job-sharing models and support flexible and remote working where possible.

　　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.

　　Our recruitment decisions are based on selecting the best person for the job, regardless of gender, religion, age, colour, race, sexual orientation, nationality or disability.

　　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

　　Austria

　　Site

　　Schaftenau

　　Company / Legal Entity

　　NVS Pharmaceutical Manu. GmbH

　　Functional Area

　　Technical Operations

　　Job Type

　　Full Time

　　Employment Type

　　Regular

　　Shift Work

　　No