Technical Transfer Lead

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

Kundl | Full time

Band

Level 4

Job Description Summary

More than 40 years! This is our expertise in Biotech production and a growing product portfolio including proteins, as well as new future key technologies such as pDNA and mRNA manufacturing. Join the Manufacturing Science and Technology team in Drug Substance Kundl as Technical Transfer Lead and participate at the frontline in pioneering the future of our Biologics and 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, HSE, CDMO 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:

• Act as single point of contact (SPOC) on site for technical transfers: Lead and steer all activities for assigned projects on site level (process, technology, analytics, capacity, etc.).

• Form and lead site project team - set priorities for project and project team meetings, coordinate project team activities, ensure that Novartis guidelines as well as HSE and corresponding GMP guidelines are met.

• Establish site project plan, elaborate scientifically sound technical strategies with project team, develop contingency plans, identify hurdles, and propose solutions.

• Assess and plan site resource needs and get management approval for the overall project costs (e.g., FTEs, batch costs, investments, and external costs), strategy and timelines.

• Perform technical feasibility assessment for supply point decision in close collaboration with other stakeholders. Determine scope / design of technical batches for transfer.

• Initiate local change control in system on site and ensure approval and closure.

• 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:

• 4 years of relevant experience in pharmaceutical manufacturing, tech transfer management / manufacturing science and technology / technical development / quality

• Comprehensive know how in biotechnology processes with experience in executing process transfers

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

• Fluent in English and proficient in German

• Project management experience

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!

You’ll receive:

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.

Skills Desired

Applied Statistics, Applied Statistics, Assembly Language, Biologics, Biology, Biotechnology, Change Control, 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 Process, Manufacturing Production, Manufacturing Technologies, Process and Cleaning Validation, Process Control, Process Simulation, Process Transfers, Product Transfers {+ 6 more}