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Job ID
379977BR
Aug 02, 2023
Austria
Job Description
Technical Transfer Lead (d/f/m), Kundl, Tyrol, Austria
2023 will potentially see Sandoz become a standalone organization! Already a global market leader in Generics and Biosimilar medicine, this is an exciting, once-in-a-career opportunity to set our own path forward as an independent, purpose-driven organization, and as the founders of a new Sandoz, this is a time of immense opportunity for us all, both professionally and personally!
Together we will shape the future of Sandoz… are you ready to make a difference?
As a Technical Transfer Lead (d/f/m), you are responsible for technology transfer activities at site level (within, inbound and outbound) for internal and external products and projects, including any scale-up or other process adaptations. You lead the technical transfer project team at site and liaise efficiently with involved functions (e.g. Technical Development, Supply Chain, Production Unit, Quality Control, HSE, other sites and global teams)
Your key responsibilities:
Your responsibilities include, but are not limited to:
2023 will potentially see Sandoz become a standalone organization! Already a global market leader in Generics and Biosimilar medicine, this is an exciting, once-in-a-career opportunity to set our own path forward as an independent, purpose-driven organization, and as the founders of a new Sandoz, this is a time of immense opportunity for us all, both professionally and personally!
Together we will shape the future of Sandoz… are you ready to make a difference?
As a Technical Transfer Lead (d/f/m), you are responsible for technology transfer activities at site level (within, inbound and outbound) for internal and external products and projects, including any scale-up or other process adaptations. You lead the technical transfer project team at site and liaise efficiently with involved functions (e.g. Technical Development, Supply Chain, Production Unit, Quality Control, HSE, other sites and global teams)
Your key responsibilities:
Your responsibilities include, but are not limited to:
- manage all steps of transfer from planning of first tech batch to hand over of transferred product routine production
- Review and update Quality Risk Assessment (QRA) prior to transfer and prior to validation, adapt control strategy if needed.
- Review first APQR after transfer to ensure adequate product performance
- Ensure that all relevant technical information and documentation for validation is available.
- Define pre-validation / validation strategy incl. process, cleaning, packaging and supportive studies (e.g., hold times).
- Coordinate technical, regulatory and validation batches at site.
- Support Validation Lead / Validation Expert in creation of validation protocol and report.
- Report to management
Diversity & Inclusion / EEO
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Minimum Requirements
What you’ll bring to the role:
Essential:
Why Sandoz?
Almost 500 million patients were touched by Sandoz generic and biosimilar medicines in 2022 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.
We are at a pivotal moment in our history giving us the freedom to invest in our future so we can continue to help millions of people access affordable high-quality medicines. Together we will shape the future of Sandoz, building an organization from the ground up and in return, experience an ambitious environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!
The future is ours to shape!
Imagine what you could do here at Sandoz!
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. 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 €60,212.18/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 hybrid working where possible.
Join our Sandoz Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: https://talentnetwork.novartis.com/sandoztalentpool
#Sandoz
Essential:
- Education: University degree (MSc. or PhD) in Pharmacy, Chemistry, Biology, Biochemistry, Biotechnology, Biochemical Engineering or equivalent degree
- Experience: Minimum 6 years of relevant professional experience in manufacturing / manufacturing science and technology / technical development / quality
- Proven understanding of pharmaceutical manufacturing and packaging processes, Biotech production (Up- and Downstream) and experience in executing process transfers
- Understanding and oversight of relevant regulatory requirements, e.g. GMPs, ICH Q-guidelines
- Proven track record in leading interdisciplinary teams and project management skills
- Excellent communication skills
- Languages: Proficient in English and German
Why Sandoz?
Almost 500 million patients were touched by Sandoz generic and biosimilar medicines in 2022 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.
We are at a pivotal moment in our history giving us the freedom to invest in our future so we can continue to help millions of people access affordable high-quality medicines. Together we will shape the future of Sandoz, building an organization from the ground up and in return, experience an ambitious environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!
The future is ours to shape!
Imagine what you could do here at Sandoz!
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. 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 €60,212.18/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 hybrid working where possible.
Join our Sandoz Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: https://talentnetwork.novartis.com/sandoztalentpool
#Sandoz
Division
SANDOZ
Business Unit
Anti-Infectives STO
Location
Austria
Site
Kundl
Company / Legal Entity
Sandoz GmbH
Functional Area
Technical Operations
Job Type
Full Time
Employment Type
Regular
Shift Work
No
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