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Manager global technology transfer

STADA Group
Publicada el 3 noviembre
Descripción

ABOUT US

At STADA we pursue the purpose of "Taking care of people's health as a trusted partner." All our decisions and actions are driven by our purpose, vision and values. With our wide range of products: Generics, Consumer Healthcare and Specialties, we offer patients, doctors and pharmacists a wide range of therapeutic options.

Around 13,000 employees live our values of Integrity, Entrepreneurship, Agility and One STADA, in order to achieve our ambitious goals and shape a successful future for our company. We continually expand our goals in line with our ambition, and we achieve them with passion, commitment and a growth mindset. Do you want to be part of a successful international pharmaceutical company and grow with us?

Manager Global Technology Transfer is responsible for leading end-to-end Technology Transfer execution providing Project Management, scientific and technical expertise, e.g., in quality, technology transfer, regulatory.

KEY RESPONSIBILITIES

*Lead and manage Tech Transfer projects effectively and independently, ensuring deliverables are completed in time, at agreed costs and carefully balancing benefits & risks

*Define Project strategy, Project Team and create end-to-end Project Plan capturing project risks including mitigation strategy

*Coordinate cross-functional Project Team across internal stakeholders (Global and local TechOps functions: QA, QC, AS&T, MS&T, ESO, RA, Commercial Transfer Team), as well as the third parties when involved in the project scope (CMOs) e.g. transfer Projects to the Contract Manufacturer

*Run project meetings to monitor project milestones, track project execution and report on progres

*Ensure cross-functional alignment and joint decision-making, define actions in project meetings and follow up on execution with project team members

*Provide scientific and technical expertise, e.g., in quality, regulatory, tech transfer and resolve issues which occur as part of daily business to ensure cross-functional information flow on the way to adhere to the project schedule

*Consolidate Master Documentation (Technical Package) for BC calculation and provide technical expertise on transfer feasibility to the target site

*Check that content of GMP documents is correct and complete and in compliance with the dossiers

*Support manufacturing sites to produce trial and validation batches (provide onsite support)

*Write Product Performance Review – Report after feasibility trials that summarizes conclusions and recommendation for validation batches

*Prepare the updates to Module 3 according to technology transfer results

*Prepare the variation documentation in accordance with local regulatory requirements of impacted countries

*Support product launches from the new site following transfer in cooperation with Commercial Transfer Team, Supply Chain, QA, RA.

EXPERIENCE

*University degree in Pharmacy, Chemistry/Chemical Engineering, Biology (Life Sciences) or comparable field

*Fluent in English (written and spoken)

*More than 5 years of work experience in Pharma Industry (in depth knowledge preferably in technology transfers, product development, manufacturing, or regulatory affairs). It can independently manage all areas of Tech Transfer Projects: quality, regulatory and technical

*Project management experience and capability to lead multi-functional teams

*Learning agility – as ongoing, proactive, and self-motivated pursuit of knowledge

*Business/market/technology savvy - understanding business and impact on business

*Growth mindset- sees obstacles as surmountable challenges

*Strong problem solver with the ability to multitask and make sound decisions in a fast-moving environment

*Integrity as concept of consistency of actions, values, methods, measures, principles, expectations, and outcomes

*Open to travel globally flexibly

We look forward to receiving your application through our job portal. At O ne STADA Career Portal you will also find more job opportunities as we are always looking for talent to strengthen our team in line with our growth ambitions.

STADA offers a competitive environment for personal and professional development in a growing company full of opportunities.

Our future project requires dynamic and proactive professionals, capable of adding value in a changing environment.

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