Erik Steffensen

FAQ About Erik Steffensen

• What is Erik Steffensen's address?

  Erik Steffensen is located at
  Denmark

• What is Erik Steffensen's job title?

  Erik Steffensen is a
  I founded Spot-on Pharma Consulting in 2023. The company provides consulting within Product & Process Development, Manufacturing, and Quality for pharmaceutical drugs, medical devices, and combination products - see further details at our website: https://spotonpharmaconsulting.com/ Prior to establishing Spot-on Pharma Consulting I worked for 25 years at Novo Nordisk within Product & Process Development, Manufacturing, and Quality. Here I had roles as both line manager, project manager, and specialist. I have in-depth experience with both drug substance, drug product, medical devices and combination products. I hold a master’s degree in Chemical Engineering and Biotechnology from Technical University of Denmark (DTU) in addition to a diploma in Business Administration from Copenhagen Business School (CBS). Throughout my career I have been involved in numerous development projects within small molecules, biologics and advanced therapy medicinal products. I have domain expertise within drug and device development covering Target Product Profile, lead candidate selection, clinical trials, product & process development, manufacturing process design, scale-up, process validation, technology transfer and regulatory submission. I have many years of experience within manufacturing of pharmaceutical drugs and medical devices and I have a proven track record of increasing the productivity of the manufacturing processes by combining lean tools and domain expertise to make simplified processes which are GMP compliant and ready for digitalisation. I have solid experience preparing supply chain and manufacturing strategies involving suppliers and Contract Manufacturing Organisations (CMOs). Furthermore, I have experience being a Qualified Person (QP) with broad responsibility for quality and compliance across manufacturing sites. Throughout the years I have gained extensive experience interacting with health authorities. I have prepared regulatory strategies and I have been writing and reviewing hundreds of regulatory documents and the underlying scientific reports. Furthermore, I have participated in more than 100 GMP inspections of which around 30 have been by US FDA. Fuse Vectors

• What industry does Erik Steffensen currently work in?

  Erik Steffensen currently works in the
  Fuse Vectors

• What is Erik Steffensen's area of expertise?

  Erik Steffensen specializes in
  I founded Spot-on Pharma Consulting in 2023. The company provides consulting within Product & Process Development, Manufacturing, and Quality for pharmaceutical drugs, medical devices, and combination products - see further details at our website: https://spotonpharmaconsulting.com/ Prior to establishing Spot-on Pharma Consulting I worked for 25 years at Novo Nordisk within Product & Process Development, Manufacturing, and Quality. Here I had roles as both line manager, project manager, and specialist. I have in-depth experience with both drug substance, drug product, medical devices and combination products. I hold a master’s degree in Chemical Engineering and Biotechnology from Technical University of Denmark (DTU) in addition to a diploma in Business Administration from Copenhagen Business School (CBS). Throughout my career I have been involved in numerous development projects within small molecules, biologics and advanced therapy medicinal products. I have domain expertise within drug and device development covering Target Product Profile, lead candidate selection, clinical trials, product & process development, manufacturing process design, scale-up, process validation, technology transfer and regulatory submission. I have many years of experience within manufacturing of pharmaceutical drugs and medical devices and I have a proven track record of increasing the productivity of the manufacturing processes by combining lean tools and domain expertise to make simplified processes which are GMP compliant and ready for digitalisation. I have solid experience preparing supply chain and manufacturing strategies involving suppliers and Contract Manufacturing Organisations (CMOs). Furthermore, I have experience being a Qualified Person (QP) with broad responsibility for quality and compliance across manufacturing sites. Throughout the years I have gained extensive experience interacting with health authorities. I have prepared regulatory strategies and I have been writing and reviewing hundreds of regulatory documents and the underlying scientific reports. Furthermore, I have participated in more than 100 GMP inspections of which around 30 have been by US FDA.

• Which languages does Erik Steffensen speak? 

  Erik Steffensen speaks the following languages:
  No languages available.

• Which industries has Erik Steffensen previously worked in?   

  Erik Steffensen has prior experience in the following industries:
  Novo Nordisk , Novo Nordisk , Novo Nordisk , Novo Nordisk , Novo Nordisk , Novo Nordisk , Novo Nordisk , Novozymes

• What is Erik Steffensen’s work experience?  

  Erik Steffensen has the following professional experience:
  Fuse Vectors , Pharmakon , Spot On Pharma Consulting , Dtu Technical University , Umamamia , Novo Nordisk , Novo Nordisk , Novo Nordisk , Novo Nordisk , Novo Nordisk , Novo Nordisk , Novo Nordisk , Novozymes .

• How can I find Erik Steffensen on LinkedIn?  

  You can view Erik Steffensen’s
  LinkedIn profile at LinkedIn URL.

• What are Erik Steffensen’s work email addresses?  

  Erik Steffensen’s work email addresses are
  [email protected] .

• What company does Erik Steffensen work for?  

  Erik Steffensen works at
  Fuse Vectors