ESO Technical Manager (m/f/d) Pharmaceutical Manufacturing

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Irfa******

  • Germany 
  • Last Update: 03.05.2019 at 12:00

Job Type
Full Time
Start
ASAP
Duration
6 Month +
Place
Munich, DE
Country
Germany

Category


Healthcare

Description


Key Responsibilities
  • Technical interface to external suppliers Establish partnership with external suppliers with focus to ensure and improve product process capability, keep the knowledge of process up to date and maintain the product in constant state of validation
  • Support respective external suppliers with science- and risk-based approaches to ensure that product quality can be sustainably reproduced
  • Product/ technical stewardship for defined key molecules Act as SPOC to maintain the oversight and knowledge for entire manufacturing process throughout the entire commercial lifecycle at given external suppliers
  • Ensure a proper understanding of manufacturing process and influencing factors (i.e. CQAs, CMAs and CPP) to ensure product quality and process robustness at the commercialization site
  • Assess impact of technical changes, assess technical feasibility and determine scope/ design of technical batches, challenge technical risk and business benefit of proposed technical changes
  • Contribute to the registration strategy and ensure alignment of (regulatory) timelines for technical changes, transfers, launches and/or major deviations
  • Lead / support root cause investigation of product and process failures. Effectively liaise with external suppliers to initiate and lead/support product/ process remediation/ improvement activities, involving cross-functional teams and with clear interfaces to Quality, Operations, Engineering and Technical Development
  • Maintain division and/or cross-division networks to share lessons learned and best practices related to process and technologies validation
  • Support Validation Lead and Experts to assess need and plan validations, assess revalidation need
About Sandoz Minimum requirements Sandoz is a global leader in generic pharmaceuticals and biosimilars. As a division of the Novartis Group, our purpose is to discover new ways to improve and extend people’s lives. We contribute to society’s ability to support growing healthcare needs by pioneering novel approaches to help people around the world access high-quality medicine. Our portfolio of approximately 1000 molecules, covering all major therapeutic areas, accounted for 2017 sales of USD 10.1 billion. In 2017, our products reached well over 500 million patients. Sandoz is headquartered in Holzkirchen, in Germany’s Greater Munich area. Benefits Of Working For Sandoz
  • Competitive salary
  • Performance based annual bonus
  • Work/life integration
  • Eligible to Sandoz pension plan
  • 30 working days' holiday per calendar year
  • Subsidised on-site cafeteria
  • Free shuttle bus between Sandoz and Holzkirchen train station
  • Additional benefits
‘I came for the job, I stay for the culture’ The ideal candidate will have
  • BSc. in Pharmacy, Pharmaceutical Technology, Chemistry or equivalent scientific Degree, ideally MSc. or PhD
  • Minimum of 5 years of experience in Pharmaceutical/ solids manufacturing
  • Experience in a global/matrix environment
  • Comprehensive know-how in pharmaceutical technology
  • Solid experience in project management and/or drug development
  • Sound experience of data handling and applied statistics
  • Fluent in English, 2nd language is a plus
Why consider Novartis? 927 million. That’s how many lives our products touched in 2017. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this how can we continue to improve and extend even more people’s lives? We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

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