Analytical Development Scientist

You have been working in a R&D and QC environment and want to take a step further in your career? The jump right in!
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What we offer

Joining our consulting team means giving your career a step forward. Thanks to the privileged partnership we have with our well-established clients, leaders in their domain, we offer our consultants unique projects to develop their skills, and put their professional experience in the pharma industry on the fast track.

As an expert on the client side, in Belgium, you can count on us to support you at each step of your project thanks to regular touch points with our Key Account Manager. We then also carefully choose with you what would be your next assignment that is matching your career goal whether it is in Consulting or in one of our Functional Services Platforms.

We invest considerable time and resources in training our staff (technical and non-technical courses) to continuously support you in your personal and professional growth. On top of this, you will receive a complete salary package including attractive extra-legal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…) based on your background and experience.

 

Job Description

Keyrus Life Science is looking for an Analytical Development Scientist to join our consulting team for a client project based in Walloon Brabant, Belgium. 

Your challenges will be : 

  • Provide and develop New Biological Entity (NBE) and New Chemical Entity (NCE) stability and Critical Material (CM) knowledge and expertise on
    the product, regulation and processes.
  • Participate to the interface, where relevant with QC and development
    laboratories, Corporate analytical services, manufacturing and supply chain
    Department, Global Regulatory affairs, etc.
  • Participate to the management of regulatory aspect linked to the stability and CM activities.
  • Contribute to the operationnall design of stability study.
  • Follow up of stability program in scope.
  • Review and approval of protocol and report.
  • Review and approval of report
  • Manage and optimize the availability and central stock for analytical supplies for the activities and Central stock of Reference Standards.
  • Participate to the development and the implementation of a Corporate repository for analytical supplies
  • Act as key user / expert LIMS stab, E-study, Disco and LIMS std and reagents.
  • Ensure product and system training and sharing of knowledge with less/no
    experienced member of the team.
  • Ensure supervision of climatic chambers, sample storage, sample flow.
  • Ensure follow up of deviations and appropriate root cause analysis, follow up of preventives and correctives actions.
  • Participate to the establishment of investment and OPEX (operational expenses) budgets.

 

Profile

  • Master's degree and 3 years in pharmaceutical industry (R&D and commercial area).
  • Experience in stability studies management including reporting and statistical analysis.
  • Must have experience in project management.
  • Must have experience of the QC ecosystem (Analytical transfer and validation, Investigation and Capa).
  • Must have experience in a GMP regulated laboratory management, sop redaction, etc.).
  • Strong NCE and NBE Analytical expertise is a must.
  • Experience with FDA, European and Japanese investigators during on-site inspections, and experience interacting with Regulatory review staff on submission issues.
  • English level: Fluent

 

Who we are

Keyrus Life Science is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our ‘human’ approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.

At Keyrus Life Science we’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better

From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.

 

Or, know someone who would be a perfect fit? Let them know!

Walloon Brabant

Walloon Brabant
1470 Walloon Brabant Directions

Our offices are the place where you are always welcome when you are not working on client's site or from home. Every single person that joins us is met in a personal and unique way.

What is really common to all of us, is the envy to contribute to the improvement of people’s health. Every employee being part of Keyrus Life Science is therefore fully committed to making the world a better place to live.   

With us, you will be part of our family and feel our human approach culture as of Day 1! 

Already working at Keyrus Life Science Belgium?

Let’s recruit together and find your next colleague.

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