19141 - Reference Standard Scientific Project lead

il y a 1 mois

Beerse, Belgique Randstad Travail à distance Freelance Temps plein

In the Clinical Release and Stability (CRS) team, we are looking for a Reference Standard Scientific Project lead.

The Clinical Release and Stability (CRS) team is a critical part of the Analytical Development department in the Discovery, Product Development & Supply (DPDS) organization within Johnson & Johnson Innovative Medicine. The reference standard ownership strives for a fully scientific understanding of the reference standard requirements for a project in all clinical development phases.


In this role, the Reference Standard Scientific Project lead will be assigned to several development projects for which you will handle all reference standard related aspects and will be the âgo-toâ person when it comes down to certification of reference standards and related questions for the assigned development projects.

key responsibilities

    • Leads and participates in scientific meetings as appropriate to support team goals.

    • Prepares protocol and CoA, independently and in time, based on chemical and project knowledge, as per the global regulations and requirements.

    • Coordinate analytical testing, scientifically support labs (internal and external) and decide on COA (e.g., storage conditions, re-test date, â¦) by interpreting and evaluating generated data.

    • Initiates and contributes to quality events, leads Reference standard related escalations, performs impact assessments and risk assessment, and defines corrective actions.

    • Responsible for maintaining the stock of reference standards.

    • Supports questions from internal and external filings.

    • Participates in trainings and continuous improvement initiatives.

    • Interprets the regulatory guidelines for quality and EHS and ensures their compliance.

    • Ensure compliance with all relevant regulations, GMP and safety.

      qualifications

        • Masterâs degree in chemistry, Bio-engineering, or Pharmaceutical Sciences, or equivalent through experience

        • Bachelor's at least 2 years experience within analytical techniques

        • Profound knowledge and experience of analytical techniques required for drug substance and related compounds.

        • Strong planning and tracking skills, well organized and capable of handling multiple projects with respect to priorities and resources

        • Excellent organization, communication skills in a team setting.

        • Understanding of regulatory guidelines for quality

        • Flexible and adapt quickly to constantly evolving business needs.

        • Good written and verbal communication skills in English and Dutch language

        • Practical experience in industry and knowledge of GMP regulations are an asset.

        • · âCan do mentalityâ and taking full ownership of your work

          key benefits

          You can fill this position through Randstad Professionals as a consultant

          In return for your performance and flexibility, we offer you a salary package with some interesting extras, such as

          • Gross salary according to your experience

          • Lunch vouchers of â¬7 per day worked

          • Net remuneration of â¬80 per month

          • Company car with fuel card (subject to conditions) or Mileage allowance

          • Hospitalisation insurance

          • 1 extra day's holiday per month worked

          • End of year bonus

          • Pension Plan

          • ECO vouchers worth â¬250 (on an annual basis, pro rata)

          • Training opportunities


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    In the Clinical Release and Stability (CRS) team, we are looking for a Reference Standard Scientific Project lead.The Clinical Release and Stability (CRS) team is a critical part of the Analytical Development department in the Discovery, Product Development & Supply (DPDS) organization within Johnson & Johnson Innovative Medicine. The reference standard...

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    Beerse, Flandre, Belgique Randstad Temps plein

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