Manager Global Technology Transfer

STADA
STADA
Sant just desvern (barcelona)PresencialCompetitivoPublicado ayerIndefinido
🇬🇧Inglés requerido
STADA

Manager Global Technology Transfer

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Manager Global Technology Transfer

Barcelona |Spain | Full-time | Permanent

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 progress
  • 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

STADA Group promotes its diverse culture, regardless of gender, age, social or ethnic origin, disabilities, religion, ideology or sexual orientation. We use the strength of this diversity to develop creative ideas, Expand our experience and increase innovative strength. Our focus is on equal opportunities, respectful cooperation and the promotion of an inclusive working environment.

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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