Technical Manager MS&T ESO-BIO

vor 1 Woche

Kundl, Tirol, Österreich Healthcare Businesswomen's Association Vollzeit

Job Description Summary

-Technical Transfer LeadResponsible for technology transfer activities at site level (within, inbound and outbound), including any scale-up or other process adaptations.Leads technical transfer project team at site and liaises efficiently with involved functions (e.g. Technical Development, Supply Chain, Production Unit, Quality Control, HSE, other sites.).Product StewardOwns the process knowledge of the product(s) assigned throughout the commercial lifecycle, maintains the oversight on process capability, through data trending and statistical analysis of critical variables, ensuring process(es) are robust, in continued state of validation and continuously improving.Ensures seamless flow of knowledge and information across functions, and with other Sites when applicable, with focus on the assigned product(s). Provides second line technical/scientific process support.Technical StewardProvides to the Site the specialist knowledge and expertise, as Subject Matter Expert (SME), of specific pharmaceutical processes or process technologies (e.g. Technical Steward for galenics, for film coating, biologics – upstream or downstream, etc.).Oversees processes and standards to maintain and improve existing and to implement new innovative manufacturing technologies.Validation LeadResponsible for developing, implementing and managing the site process validation, primary packaging validation, cleaning validation and revalidation strategies to meet cGMP and quality requirements on time and on budget to ensure that programs are compliant with Regulatory Authorities' expectations and related SOPs.Senior Scientist MSAndTDesign, plan, perform, interpret and report scientific experiments under the lead of the department head to contribute to overall MSAndT strategies and objectives.

Job Description

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.

Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.

Join us as a Founder of our 'new' Sandoz

Your key responsibilities:

Your responsibilities include, but are not limited to:

  • Maintaining oversight of processes and technical changes for the assigned product in a specific contract manufacturing organization (from bulk manufacturing to device assembly) ) for legacy and development products.
  • Maintaining the knowledge and the history of the products throughout the commercial lifecycle, since transfer from development to the present moment
  • Leads technical transfers from process perspective, controlling and ensuring the maintenance of technical documentation, e.g. tech transfer documentation and Quality Risk Analysis and liaises efficiently with involved functions
  • Liaises with various functions internal and external, acting as a representative of MS&T within the relevant supplier relationship teams. Closely cooperating with ESO functions (Quality Assurance, LCM, SCM, etc.), and establishing relations with CMOs with special focus to ensure and improve product process capability, to keep up to date the knowledge of the process and to maintain the product in a constant state of validation
  • Tracking the parameters for continuous process verification received from CMOs. Monitors all critical variables and key variables as required for the assigned products (critical process parameters, in-process control parameters, quality attributes, characteristics of raw materials, etc.) by means of statistical analysis and by performing regular data trending for specific products
  • Understanding and management of data trending and statistical analysis for the following purposes
  • Deepening and broadening process understanding and knowledge
  • Detecting issues related to process capability, e.g. systematic quality defects

What you'll bring to the role:

  • At least a university degree in pharmacy, chemistry or other natural/technical science degree
  • Fluent in English (spoken & written)
  • A minimum of 5 years of relevant working experience in aseptic drug product manufacturing (product presentations/ technologies, aseptic processing and microbial reduction techniques, sterile manufacturing equipment)
  • Demonstrated technical expertise in manufacturing process science and drug development
  • Commitment to travel

Possible job locations are despite the preferred location Kundl (Austria) also Ljubljana (Slovenia) and Barcelona (Spain).

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more

With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate 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.

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.

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: Job search | Sandoz

#Sandoz

Skills Desired

Applied Statistics, Assembly Language, 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, Risk Management, Root Cause Analysis (RCA), Scientific Method, Six Sigma, Statistical Analysis, Technology Transfer
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