Senior Scientist M/V/X

Beschrijving van de functie

Will you be our new ambassador?

Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to pass our team.?

Let's look together at your first challenge with us!

Senior Scientist

Our partners innovate to bring treatments to their patients that significantly improve their lives.?Together with the government and other health partners they are working towards qualitative, affordable and accessible healthcare.

For one of our pharmaceutical partners we are looking for a Senior Scientist. In this position you will work both on site as remote.

Main Responsibilities

• Represent the GMP QC Lab in cross departmental teams and in external contacts as subject matter expert

• Be responsible for the technology transfer of analytical methods from the GMP Unit to a Receiving Unit

• Perform method validation according to current GMP regulations, ICH guidelines and Pharmacopeia. You perform method life cycle management and keep oversight over methods performed on different sites

• Assist in global expansion of a commercial product and you adapt the analytical methods based on gap assessments to the requirements of local authorities while still maintaining the

  validated status of the analytical method

• Perform technical review of analytical results (such as SEC, RPC, IEX-HPLC, CGE, UV spectrometry, compendial methods, and potency assays (Biacore), assist and guide the Associate Scientist in technical problem solving and conduct OOx-investigations if required
• Follow up on trending data and define appropriate actions if required
• Organize trainings as subject matter expert (on methods, laboratory systems)
• Be responsible for the coordination, execution and the quality control of the activities executed by the GMP QC Lab
• Write, review and finalize the study plans and the final reports for the release testing, stability studies, method validation and any other studies performed in the GMP laboratory
• Write and follow-up all quality related documents such as change controls, deviations, .

Who are you?

Qualifications/Education & work experience

. PhD with at least a first experience within the pharma industry or Master with 7-10 years of relevant experience

. You have experience in physico-chemical analysis and/or potency testing of proteins

. Experience with technology transfer, method life cycle management, stability studies and release testing in a commercial setting is an asset

. Experience with GMP guidelines and a GMP working environment

. Knowledge of ICH and Pharmacopeia

. MS Office: proficient level

. Fluent English, written and spoken, fluent in Dutch preferred

Competencies:

? You combine technical expertise with good people management skills

? Team player, enthusiastic, independent and self-motivated

? Excellent communication and writing skills are required

? Sense for initiative, quality, accuracy and detail

What can Jefferson Wells do for you?

As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education.?For this project you have the possibility to work partially homebased.

Are you interested? Apply now!

Jouw profiel

Who are you?

Qualifications/Education & work experience

. PhD with at least a first experience within the pharma industry or Master with 7-10 years of relevant experience

. You have experience in physico-chemical analysis and/or potency testing of proteins

. Experience with technology transfer, method life cycle management, stability studies and release testing in a commercial setting is an asset

. Experience with GMP guidelines and a GMP working environment

. Knowledge of ICH and Pharmacopeia

. MS Office: proficient level

. Fluent English, written and spoken, fluent in Dutch preferred

Competencies:

? You combine technical expertise with good people management skills

? Team player, enthusiastic, independent and self-motivated

? Excellent communication and writing skills are required

? Sense for initiative, quality, accuracy and detail

Taalvaardigheden

• Nederlands (troef)

  • Begrijpen : Onafhankelijk - (B1)
  • Schrijven : Onafhankelijk - (B1)
  • Lezen : Onafhankelijk - (B1)
  • Spreken : Onafhankelijk - (B1)

• Engels (troef)

  • Begrijpen : Onafhankelijk - (B1)
  • Schrijven : Onafhankelijk - (B1)
  • Lezen : Onafhankelijk - (B1)
  • Spreken : Onafhankelijk - (B1)

Voordelen van de betrekking

What can Jefferson Wells do for you?

As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education.?For this project you have the possibility to work partially homebased.

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