Technical Transfer Lead (m/f/d), Schaftenau, Tirol, Austria

Job Description Summary

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 front-line 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 Unit functions, 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.

 

Job Description

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; Act as single point of contact (SPOC)
• 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 Unit, 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.

Essential Requirements:

• Minimum of 3 years of relevant experience in pharmaceutical manufacturing, tech 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
• Solid 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?
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 more here: https://www.novartis.com/about/strategy/people-and-culture

You’ll receive:
You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development opportunities as well as worldwide career possibilities 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 € 64.023,54 year (on a full-time basis). In most cases, the actual salary will be 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: :

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

Adjustments for Applicants with Disabilities:
If because of a medical condition, physical disability or a neurodiverse condition you require an adjustment during the recruitment process, please reach out to disabilities.austria@novartis.com and let us know the nature of your request as well as your contact information. The support which we can provide will include advice on suitable positions as well as guidance at all stages of the application process. Austrian law provides candidates the opportunity to involve the local disability representative, Behindertenvertrauensperson (BVP), in the application process. If you would like to request this, please let us know in advance as a note on your CV.

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

 

Skills Desired

Applied Statistics, Applied Statistics, Assembly Language, Biotechnology, Change Control, Change Management, Chemical Engineering, Continual Improvement Process, Cost Reduction, Data Analytics, Electronic Components, General Hse Knowledge  , Including Gdp, Knowledge Of Capa, Knowledge Of Gmp, Lean Manufacturing, Manufacturing, Manufacturing Process, Manufacturing Production, Manufacturing Technologies, Pharmaceutical Manufacturing, Problem Solving, Process and Cleaning Validation, Process Control, Process Simulation {+ 7 more}