Specialist External Analytical Sciences

MSD Malaysia

Oss

On-site

EUR 85,000 - 110,000

Full time

9 days ago
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Benefits offered by this job

Competitive salary
35.5 days paid leave
Travel allowance
Pension scheme
Company restaurant
Parking
Sports membership support
Lyra Health wellbeing
Prayer/meditation room
Development opportunities

Job summary

MSD Oss, Netherlands, is seeking a Specialist External Analytical Sciences to oversee the external testing network for large molecule biologics and vaccines. You will act as the primary technical contact with external labs, ensuring analytical robustness, regulatory compliance and on-time releases.

You will collaborate with global Quality, Regulatory Affairs and manufacturing partners, driving method transfers, validation and lifecycle activities while improving analytical performance and data

Qualifications

  • bachelor’s degree or higher in a relevant scientific discipline with several years of industry experience
  • experience in biologics, vaccines or large molecule products
  • experience with analytical method development, validation, transfer and lifecycle management
  • knowledge of analytical testing for biologics and vaccines (ELISA, cell-based assays, chromatography)
  • experience in a GxP environment (Quality Control, Technical Operations or commercial support)
  • familiarity with regulatory requirements (ICH, USP, Ph. Eur.)
  • strong communication, project management and stakeholder skills

Responsibilities

  • Provide analytical oversight for commercial large molecule biologics and vaccines within the external testing network
  • Serve as primary technical contact for external testing labs and manufacturing partners
  • Foster cross-functional collaboration with internal and external stakeholders
  • Lead analytical investigations, deviations and troubleshooting to resolve complex testing challenges
  • Drive continuous improvement for analytical performance, compliance and efficiency
  • Support method lifecycle activities including transfer, validation and monitoring
  • Manage projects, timelines and deliverables across multiple initiatives
  • Ensure inspection readiness and regulatory compliance in documentation for release and submissions

Skills

Analytical method development
Validation
Transfer & lifecycle management
ELISA
Cell-based assays
Chromatography methods
GxP knowledge
Project management
Stakeholder management

Education

Bachelor’s degree in Biology/Chemistry/ Biochemistry
Master’s degree in relevant field
PhD in relevant field

Job description

Job Description Join our Global Quality organization and play a key role in ensuring the uninterrupted supply of life-changing biologics and vaccines to patients worldwide. This is a highly visible role where analytical expertise, stakeholder management and external laboratory oversight come together in a dynamic international environment. For our Oss site, we are looking for a: Specialist External Analytical Sciences Welcome in our team The Global Quality - Large Molecule Analytical Sciences (GQ-LMAS) team provides global analytical technical oversight for late-stage pipeline programs, commercial products and lifecycle management activities across biologics, vaccines and cross-modality compounds. Our team operates in a fast-paced, highly collaborative environment and is responsible for maintaining a robust analytical testing network that supports product launches, pipeline acceleration and the uninterrupted supply of commercial products. We work closely with internal and external partners across the globe to ensure analytical excellence, compliance and operational success. As a Specialist External Analytical Sciences, you will work with colleagues across Technical Operations, Quality, Regulatory Affairs, Microbiology and Analytical Sciences while partnering directly with external testing laboratories and manufacturing organizations.

Purpose of the role

In this position, you will provide analytical technical oversight within our global external manufacturing and testing network. You will be responsible for driving successful analytical execution at contract testing laboratories while ensuring compliance, technical robustness and on-time batch release of commercial biologics and vaccine products. A significant portion of this role involves working directly with external testing providers through regular onsite presence, enabling close collaboration, technical guidance and effective issue resolution. You will act as a key interface between internal stakeholders and external partners, ensuring analytical activities meet the highest quality and regulatory standards.

Tasks and responsibilities
  • Provide analytical oversight for commercial large molecule biologics and vaccines products within the external testing network.
  • Act as the primary technical contact for external testing laboratories and manufacturing partners.
  • Build strong relationships with internal and external stakeholders while supporting governance and cross‑functional collaboration.
  • Lead analytical investigations, deviations and troubleshooting activities to resolve complex testing challenges.
  • Drive continuous improvement initiatives to enhance analytical performance, compliance and operational efficiency.
  • Support analytical method lifecycle activities, including method transfer, validation and performance monitoring.
  • Manage projects, timelines and deliverables across multiple analytical and commercial initiatives.
  • Ensure inspection readiness and regulatory compliance while authoring and reviewing technical documentation supporting product release, licensure and regulatory submissions.
Your profile
  • Bachelor's degree in Biology, Chemistry, Biochemistry or another relevant scientific discipline with at least 5 years of relevant industry experience; or Master's degree in a relevant scientific discipline with at least 4 years of relevant industry experience; or PhD in a relevant scientific discipline with at least 2 years of relevant industry experience.
  • Minimum 2 years of experience within a laboratory environment focused on biologics, vaccines or other large molecule products.
  • Experience with analytical method development, validation, transfer and lifecycle management.
  • Strong knowledge of analytical testing for biologics and vaccines, including techniques such as ELISA, cell-based assays and chromatography methods.
  • Experience within biopharmaceutical manufacturing, Quality Control, Technical Operations or commercial product support in a GxP environment.
  • Knowledge of analytical product lifecycle activities, including IPCs, method transfer, validation, release testing, stability testing and applicable regulatory requirements (ICH, USP, Ph. Eur.).
  • Excellent communication, project management and stakeholder management skills, with the ability to troubleshoot complex issues and effectively collaborate with internal and external partners.
What we offer
  • Competitive salary based on your knowledge and experience.
  • 3% year-end payment and an annual bonus based on personal and company performance.
  • At least 35.5 days of paid leave.
  • Travel allowance and a solid pension scheme.
  • A high-quality company restaurant offering fresh and healthy options daily.
  • Excellent accessibility: the train station is located directly at our main entrance and there is ample parking available.
  • A contribution toward your personal sports membership to support your vitality.
  • A beautiful private park on the premises, ideal for a walk, break, or moment of relaxation.
  • Mental well‑being support through Lyra Health for you and your family members.
  • Access to a dedicated prayer and meditation room.
  • Extensive development opportunities thanks to the size of the site and the presence of many disciplines and global departments represented in Boxmeer.
  • A workplace within an organization that is continuously growing and evolving.

Employee Status: Regular

Job Posting End Date: 10/22/2026

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