News

Are you our Quality Assurance Manager?

SAXOCON is hiring a Quality Assurance Manager to develop and maintain our Quality Management System (QMS). SAXOCON is in the process of implementing a QMS based on ISO 13485:2016. The Quality Assurance Manager is responsible for planning and managing the QMS in close collaboration with our toxicologists and computational toxicologists.

The ideal candidate will be a QA specialist with experience working within a regulated environment and possess knowledge about the setup and maintenance of Quality Management Systems.  In addition, the ideal candidate would have experience from working within the pharmaceutical and medical device industry or other relevant scientific field.  Regulatory knowledge and experience is a plus, as is experience with internal and external audits.  In addition, a background in clinical or non-clinical Quality Assurance would also be welcomed.

The candidate will be responsible for a QMS in a fast growing Consultancy Company that serves the medical device and pharmaceutical industry. You will report directly to the CEO.

Your main responsibilities cover:

  • Overall responsibility for our ISO 13485:2016 Quality Management System, including responsibility for any associated audits.
  • Working with the operating team to establish SOP’s, standards, systems and procedures.
  • Acting as a catalyst for change and improvement in performance and quality.
  • Being an advocate for Best Practices and Quality throughout the company.
  • Interaction and communication with regulators, notified bodies and other competent authorities.

Qualifications:

We expect you to have the following qualifications:

  • MSc, or PhD, with solid technical, pharmaceutical, medical or biological background.
  • At least 3 years of Quality Assurance experience from a pharmaceutical or medical device company.
  • Proficiency and experience in the preparation of documents for QMS.
  • Super-user of MS office and flair for other IT tools.
  • Experience with ISO 13485 Compliance audit, writing standard operating

In addition you are:

  • A dedicated team player with strong collaboration skills with internal and external stakeholders as we work cross-functionally
  • Pro-active, structured, well-organized and committed to meeting deadlines
  • Able to work on multiple tasks in parallel
  • Fluent in English, both written and orally
  • Able to see the bigger picture while keeping attention to details
  • Passionate about quality management

How to apply:

Any questions you are welcome to contact our CEO Martin Friis-Mikkelsen on +4540112027.

We are happy to receive your application at hfm@saxocon.com

When to start:

As soon as possible but we are ready to wait for the right candidate.

About SAXOCON

SAXOCON is a spin-off from DTU and is partly owned by DTU. The company was founded in 2013 and we are currently expanding heavily, both in number of employees and in our portfolio of customers.

Although we are busy, we have a relaxed and informal atmosphere, where we collaborate to create high quality products to the benefit of our customers.

 


 

 

 

Are you our next senior toxicologist?

SAXOCON is hiring a senior toxicologist to join our team of toxicologists and computational toxicologists as soon as possible. You will report to the Chief Executive Officer.

Your main responsibilities cover:

  • Performing toxicological assessments in accordance with ISO, ICH and OECD guidelines/standards for drug substances, medical device, food and feed ingredients, cosmetics etc.
  • Performing risk assessments for biological evaluation reports and other medical device documentation
  • Participating in cross-functional team meetings pertaining to our deliverables
  • Providing input to and reviewing biological evaluation reports and other documents written for our customers
  • Providing input to Standard Operating Procedures

Qualifications:

We expect you to have the following qualifications:

  • An MSc, MD, DVM supplemented with a PhD within a biological or pharmaceutical discipline
  • At least 10 years of relevant nonclinical safety or toxicology experience
  • Experienced MS office user with flair for IT
  • Knowledge of or preferably experience with risk management (e.g. ISO 14971)
  • Knowledge of quality management systems (ISO 13485) and/or GMP
  • Knowledge of analytical chemistry is an asset but not a strict requirement

In addition you are:

  • A dedicated team player with strong collaboration skills with internal and external stakeholders as we work cross-functionally and our team consists of toxicologists, computational toxicologists and medical writers
  • Pro-active, structured, well-organised and committed to meeting deadlines
  • Able to work on multiple tasks in parallel
  • Fluent in English, both written and orally
  • Able to see the bigger picture while keeping attention to detail
  • Keen to provide our customers with deliverables tailored for their individual needs

How to apply:

Any questions you are welcome to contact our CEO Martin Friis-Mikkelsen on +4540112027.

We are happy to receive your application at hfm@saxocon.com

About SAXOCON

SAXOCON is a spin-off from DTU and partly owned by DTU. The company was founded in 2013 and we are currently expanding heavily, both in number of employees and in our portfolio of customers.

Although we are busy, we have a relaxed and informal atmosphere, where we collaborate to create high quality products to the benefit of our customers.

 

 

 

 

Alle fagligheder skal i spil, når vi skaber succesfuld innovation

SAXOCONs CEO Martin Friis-Mikkelsen was interviewed about the organizational setup at SAXOCON, and how it differs from the industry’s normal approach.

Se the article here (In Danish) here


DTU IP PITCH 2016

SAXOCON was invited by DTU as being a “Company success story”.

Se the presentation of SAXOCON by Martin Friis-Mikkelsen here

 

 

 


SAXOCON i Dynamo – nyhedsmagasin fra DTU

 

 

 

Se den fulde artiklen her http://emagstudio.win.dtu.dk/E-books/DYNAMO/DYNAMO_46/#/26/


Pris til QSAR-teamet på DTU

Pris for at forudsige kemiske stoffers skadelige effekter uden forsøgsdyr

Computermodeller udviklet på DTU Fødevareinstituttet kan forudsige en lang række af de skadelige effekter, forskellige kemiske stoffer kan forårsage. Det har ført til øget viden, der kan bruges til at prioritere og vurdere tusinder af kemiske stoffers sikkerhed verden over uden brug af forsøgsdyr. For arbejdet med at udvikle modellerne har forskere på instituttet modtaget en pris fra Danmarks 3R-Center. Centeret har som formål at finde alternativer til dyreforsøg.
Se artiklen her

Attend SAXOCON seminar May 31

Kravene til medicinsk udstyr er stigende. Har du styr på ISO 10993? Har du styr på, om de materialer, som du anvender i dit produkt er sikre? Følger du den del af guidelinen, som omhandler reduktion af dyreforsøg i forbindelse med den biologiske sikkerhedsvurdering?

Se mere her (in Danish)


SAXOCON expand via Ministry of Foreign Affairs

From December 2015 to February 2016 Saxocon took part in phase one of InnovationGROWTH. Business Plan and Value Proposition was analyzed and fine-tuned to put it more in line with a international strategy.

Read the article from Ministry of Foreign Affairs of Denmark about our collaboration HERE (in danish).


Medicoselskaber skal være mere opmærksomme på toksikologi

 

 

 

 

 

 

 

An article about SAXOCON in MedWatch

Please read more here


SAXOCON in DTU News

Saxocon-1_pressThe company SAXOCON was born of a good idea and an enterprising investor. And the researchers behind the idea voluntarily declined to be directly involved in the project.

Readmore here: Private investor helped DTU idea take off

 


Medico Bazar 2016

Saxocon is looking forward to welcome you to DTU Medico Bazar 2016


Medica 16-19 November 2015

Saxocon will be attending Medica 2015 from 16th to 19th of November, in Dusseldorf, Germany.  Meet us at the Danish Pavilion, booth #16, together with The Confederation of Danish Industry.


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