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(Sr) Scientist Analytical Method Development (small molecules)

Locatie

Leiden

Bedrijfsprofiel

Our client, Dr.Reddy’s Laboratories is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Their purpose is to accelerate access to affordable medicines because they believe “Good Health Can’t Wait”.
Dr.Reddy’s in Leiden is specialized in the development of generic complex injectables by empowering its people with technology, resources and freedom to innovate. Striving to be the global benchmark for excellence in science, they are driven by making good health accessible to all.
The company employs around 75 people, and is highly culturally diverse, with over 20 different nationalities represented in its workforce.

Functieomschrijving/taken

As a Sr. Analytical Scientist, you are responsible for robust analytical method development within up to validation of Analytical Methodologies. You will apply analytical Quality by Design (QbD) and Design of Experiment (DoE)/multivariate data analysis to find critical parameters of analytical methodologies. This will ideally lead to efficient optimization of the analytical methods that conform to the requirements of the ICH-, FDA/USP, and EMA guidelines.
You will also support the formulation team to increase product and process understanding while performing the required analyses and characterization. In this role you will have the responsibility to develop alternative analytical methods that are usually not found in the standard QC lab. The emphasis of the role lies in supporting the team to obtaining product and process understanding.

Profiel kandidaat

  • An academic education in chemistry, biotechnology, pharmaceutical- or biopharmaceutical sciences or a PhD in a for Dr.Reddy’s relevant subject;
  • More than at least 3 years experience (internships not included) in the pharmaceutical field. Or Msc with 8, preferably 10 years of directly relevant pharmaceutical experience;
  • Thorough knowledge of and broad experience in pharmaceutical chemical development of a product in the (bio)pharmaceutical industry is essential;
  • Several years experience in project management in a pharmaceutical environment.

    You are experienced with:
  • HPLC/UPLC analysis with PDA/UV/ELSD detection;
  • ICH guidelines, FDA and patents;
  • Development and method validation;
  • Statistical testing;
  • Quality awareness.

Arbeidsvoorwaarden

The final candidate will be offered an attractive and competitive remuneration package including insurance package and pension plan.

Contactpersonen

Marije Hoogendoorn | Senior Research Consultant
+31 6 – 23 13 51 18 | hoogendoorn@themagroup.nl

Tagcloud (Sr) Scientist Analytical Method Development (small molecules)

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