Senior Development Scientist

Bemærk at denne jobannonce er udløbet!
Annoncen er udløbet, og stillingen kan ikke længere søges. Opslaget vises udelukkende som reference

Do you enjoy working with problem-solving, technical or process challenges? Are you passionate about using data to find the best solutions? Can you set the direction for less experienced colleagues and use your experience in the tableting fields? Do you want to have both join a team of skilled colleagues in a great team? If so, you might be the new colleague we're looking for. Apply today and you can be part of a life-changing career!

The position

In this MDev (Manufacturing Development) position, you will be on top of our oral tablet production processes in close cooperation with the different production sites. You will understand and know the registration documents of our marketed products. In addition, you will drive improvements, optimizations and ensure operational stability of production processes. You will be 2. line support on technical challenges related to production e.g., blending equipment, tablet machines and automatic at-line/in-line tablet testing equipment.

Furthermore, you will be:

  • Providing support to the production in critical cases with short notice
  • Driving continuous optimization of already approved products - Life Cycle Management (LCM)
  • Using data and your analytical skills to find the best solutions
  • Using your experience from other tablet productions to improve our quality, output and cost
  • Part of the ongoing documentation to the authorities and inspections by the authorities.
  • To succeed with all this, you will need to combine your process and drug product understanding with a good quality mindset for the finished product. You will also have to build relations with your colleagues in the production, Quality Control, Quality Assurance and Regulatory Affairs areas.

    You will be the person driving collaboration in an ever-changing environment with many different stakeholders and quality or regulatory-related concerns for the drug product. When necessary you will be driving root cause analysis and trouble-shooting sessions in cooperation with the production and analytical departments. The job requires the ability to oversee and manage high level tasks across the organisation

    Qualifications

    To succeed in this position, you:

  • Hold a master’s degree and/or a PhD in science within Pharmacy, Chemistry, Engineering, or a similar field.
  • Have extensive and documented experience from within the field of CMC or manufacture, e.g., product development, support, transfer, or process validation, combined with minimum 5 years of experience within oral formulation and tablet production and final product.
  • Collect and evaluate production process data and understand the impact on tablet production
  • Possess good communication skills in both oral and written English and preferable also Danish.
  • Possess a project management toolbox to coordinate tasks between sites.
  • About the department

    Oral Finished Products (OFP) MDev Support and stability employs approximately 50 highly skilled and motivated employees with the missions to bring products from late development to market production, optimize the processes and products, support the production sites, document the stability for the products and build up the documentation for authorities for new products and for marketed products.

    The department consist of 3 teams: Drug Product & Stability, Life Cycle Management (LCM) and New Product Entry (NPE). This position is in the NPE team.

    What we do is an important part of Novo Nordisk, and as an agile department, we solve exciting and challenging tasks every day.

    Skriv i din ansøgning, at du fandt jobbet på ofir.dk


    Senior Development Scientist

    Do you enjoy working with problem-solving, technical or process challenges? Are you passionate about using data to find the best solutions? Can you set the direction for less experienced colleagues and use your experience in the tableting fields? Do you want to have both join a team of skilled colleagues in a great team? If so, you might be the new colleague we're looking for. Apply today and you can be part of a life-changing career!

    The position

    In this MDev (Manufacturing Development) position, you will be on top of our oral tablet production processes in close cooperation with the different production sites. You will understand and know the registration documents of our marketed products. In addition, you will drive improvements, optimizations and ensure operational stability of production processes. You will be 2. line support on technical challenges related to production e.g., blending equipment, tablet machines and automatic at-line/in-line tablet testing equipment.

    Furthermore, you will be:

  • Providing support to the production in critical cases with short notice
  • Driving continuous optimization of already approved products - Life Cycle Management (LCM)
  • Using data and your analytical skills to find the best solutions
  • Using your experience from other tablet productions to improve our quality, output and cost
  • Part of the ongoing documentation to the authorities and inspections by the authorities.
  • To succeed with all this, you will need to combine your process and drug product understanding with a good quality mindset for the finished product. You will also have to build relations with your colleagues in the production, Quality Control, Quality Assurance and Regulatory Affairs areas.

    You will be the person driving collaboration in an ever-changing environment with many different stakeholders and quality or regulatory-related concerns for the drug product. When necessary you will be driving root cause analysis and trouble-shooting sessions in cooperation with the production and analytical departments. The job requires the ability to oversee and manage high level tasks across the organisation

    Qualifications

    To succeed in this position, you:

  • Hold a master’s degree and/or a PhD in science within Pharmacy, Chemistry, Engineering, or a similar field.
  • Have extensive and documented experience from within the field of CMC or manufacture, e.g., product development, support, transfer, or process validation, combined with minimum 5 years of experience within oral formulation and tablet production and final product.
  • Collect and evaluate production process data and understand the impact on tablet production
  • Possess good communication skills in both oral and written English and preferable also Danish.
  • Possess a project management toolbox to coordinate tasks between sites.
  • About the department

    Oral Finished Products (OFP) MDev Support and stability employs approximately 50 highly skilled and motivated employees with the missions to bring products from late development to market production, optimize the processes and products, support the production sites, document the stability for the products and build up the documentation for authorities for new products and for marketed products.

    The department consist of 3 teams: Drug Product & Stability, Life Cycle Management (LCM) and New Product Entry (NPE). This position is in the NPE team.

    What we do is an important part of Novo Nordisk, and as an agile department, we solve exciting and challenging tasks every day.

    Skriv i din ansøgning, at du fandt jobbet på ofir.dk


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