Loading

20 ähnliche Stelle(n) gefunden

Loading

Analytical Scientist

bewerten
Bewertung abgegeben

Teoxane Laboratories were founded in 2003, in Geneva, Switzerland. Teoxane is among the top 3 Hyaluronic acid dermal filler manufacturers worldwide. Our dedication to innovation and excellence allows us to deliver a strong growth platform in the rapidly changing Aesthetics environment. We have a significant global presence in over 90 countries worldwide.

We are looking for a talented individual to fill a position in the Medical Device Industry as

 

Analytical Scientist

Teoxane Laboratories were founded in 2003, in Geneva, Switzerland. Teoxane is among the top 3 Hyaluronic acid dermal filler manufacturers worldwide. Our dedication to innovation and excellence allows us to deliver a strong growth platform in the rapidly changing Aesthetics environment. We have a significant global presence in over 90 countries worldwide.

We are looking for a talented individual to fill a position in the Medical Device Industry as

 


The product is a combined medical device (Class III) including a drug substance. It is a dermal filler consisting in a gel of Hyaluronic Acid packaged in pre-filled syringes.

 

The position is attached to the R&D team.

Your responsibilities :

In collaboration with external laboratories and / or internal R&D and QC team, the Analytical Scientist will be responsible to:

  • Manage some analytical issues within projects product development, especially:

- Extractable and Leachable studies and strategies

- Failure analysis and problem solving,

- Impurity extraction and identification, development and validation

- Polymer quantification and analysis (SEC/UV/MALS/DLS/dRI…)

  • Implement strategies in terms of:

- Analytical Development

- Demonstration of safety and performances via analytical program and results

  • Lead analytical (procedural and instrumental) troubleshooting sessions.
  • Lead discussions and rationales to authorities (FDA, Notified Body) for new products approval (in your expertise).
  • Ensure compliance with regulations and standards (FDA, MDR, ICH, USP, Eur Ph, ISO …).
  • Review, interpret, and analyze data for technical, quality and compliance to protocols, methods, SOPs.

Your profile :

  • You have a solid educational background, (Master degree in Science (Physic, Chemistry) or PhD).
  • Minimum of 5 years of experience in analytical chemistry and / or toxicology demonstrated through a combination of industry and academic performance.
  • Advanced knowledge of chemical characterization including various analytical techniques and methodologies, especially for Extractable and Leachables.
  • Advanced knowledge of general chemistry and separation science, especially in macromolecules and biopolymer sciences (polysaccharides).
  • Ability to execute projects with minimal supervision.
  • Ability to analyze data from the qualitative to the rigorously statistical and defend conclusions based on data.
  • Ability to demonstrate strong problem-solving and analytical abilities / solution oriented.
  • Ability to independently perform root cause analysis for method investigations.
  • Proven time management skills and a strong attention to detail.
  • Time management and project management skills with a strong attention to detail.
  • Full understanding of ICH guidelines, USP requirements and FDA guidance, laboratory requirements, SOPs.
  • Effective written and oral communication skills as well as presentation skills.
  • Ability to work well with others & independently.

 

 

Adresse

Rue de Lyon, 105 1203 GENEVE

Website http://www.teoxane.com

Genève / Geneva / Onex

Bewertung hinzufügen

Geben Sie hier Ihre Bewertung für die Firma TEOXANE SA ab!

Bewertung abgegeben