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Senior Scientist Analytical Biochemistry

Oss, Netherlands

Job Description

The Position

The Women’s Health Products group of Analytical Sciences (AS) has an exciting opportunity for a Senior Scientist Analytical Biochemistry, who will act as a Subject Matter Expert (SME) to support Commercial and Innovative Women’s Health products. In this position you will work in a cross functional environment with Organon partners from Regulatory-CMC, Quality and Manufacturing.

This position will be based in Oss and you are expected to work on-site in Oss for at least 3 days a week.

Welcome to our team

The Organon Analytical Sciences organization is responsible for providing analytical support for testing of Organon’s complex glyco-protein products, including release, stability and in process control. The team consists of a Director, an Associate Principal Scientist and three Senior Scientists.

Responsibilities

  • For glyco-proteins, understand the broad range of bio analytics applied in QC testing applied in release, stability and investigational studies of drug substance and drug product;
  • Analytical support for implementation of method changes and method transfer activities internally as well as in relation to contract organizations. Lead meetings, write protocols, perform data evaluation and write reports of analytical method transfers;
  • Write and review source documents for CMC modules and responses to Health Authority Questions;
  • Contribute to knowledge and analytical life cycle management;
  • Support change control process of analytical changes and contribute to risk and impact assessment of analytical changes;
  • Participate in due diligence projects in which confidential CMC evaluation of a potential partner product should be evaluated on its analytical completeness and robustness;
  • Work with teams comprised of scientists and non-scientists to effectively contribute to the analytical support strategy for multiple women’s health projects like Biosimilars.

Required Education, Experience and Skills

  • Bachelor’s or Master’s degree with at least 10 years of experience or PhD-degree with a least 5 years of experience in Biotechnology or Analytical Chemistry of large molecules;
  • Hands-on laboratory experience with biochemical tests;
  • Analytical experience in the pharmaceutical industry of glycoprotein based active ingredients. Understanding of the following techniques:
    • Glycosylation analyses, like carbohydrate profiling, CZE and IEF;
    • Activity measurement, like cell culture assays, EIA;
    • Impurity measurements, like EIAs, residual DNA and host cell protein;
    • Degradation, like HPLC, SDS PAGE and deamidation;
    • DP particle measurements;
    • Container Closure Integrity Testing;
    • Compendial testing methods;
    • Microbiology testing: Sterility, mycoplasma, Endotoxins.
  • Experience with writing technical documentation, mainly analytical protocols and reports;
  • Experience with Good Manufacturing and Good Documentation practices as well as data integrity principles;
  • Strong verbal and written communication skills in English.

Preferred Experience and Skills

  • Experience performing data analytics and data evaluation;
  • Practical knowledge of statistics;
  • Experiences with compendial testing and harmonization of compendial methods;
  • Experience working in global interdisciplinary project teams;
  • Experience in analytical problem solving;
  • Working knowledge of Chemistry Manufacturing & Control (CMC) filing requirements;
  • Experience working with Contract Organizations;
  • Experience with small molecules.

We offer

We welcome you to a truly global, dynamic and challenging environment with great opportunities for personal development. Our benefits are very competitive and the summary below will give you an idea of what you can expect.

  • Competitive salary and a 3% year-end bonus;
  • 35,5 days of leave;
  • Attractive collective health care insurance package with considerable reduction rates;
  • Solid Pension Plan;
  • Incentive Plan (bonus);
  • Commuting allowance;
  • Parental leave for both parents;
  • Numerous training, coaching and e-learning modules for long term job opportunities and development.

Secondary Job Description

Who We Are:

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions.  Our Vision is clear: A better and healthier every day for every woman.

As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.

If you require reasonable accommodation(s) in completing an application, interviewing, or otherwise participating in the employee selection process, please email us at staffingaadar@organon.com .

Search Firm Representatives Please Read Carefully
Organon LLC , does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Annualized Salary Range

Annualized Salary Range (Global)

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites

10%

Flexible Work Arrangements:

Work Week

Shift:

Valid Driving License:

No

Hazardous Material(s):

Number of Openings:

1

Requisition ID: R524235

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