Specialist External Analytical Sciences
MSD
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Benefits offered by this job
Job summary
MSD in Oss is seeking a Specialist External Analytical Sciences to provide analytical technical oversight across the external manufacturing and testing network for commercial biologics and vaccines.
In this hybrid role you will collaborate with internal teams and external laboratories to ensure regulatory compliance, on-time batch release and robust analytical performance. The position emphasizes international collaboration, issue resolution, and continuous improvement in GMP environments.
Qualifications
- Bachelor's degree in Biology, Chemistry, Biochemistry or related with 5+ years of experience.
- Master's degree with 4+ years of experience.
- PhD with 2+ years of industry experience.
- Minimum 2 years in a lab focused on biologics or vaccines.
- 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 and regulatory expectations (ICH, USP).
- Excellent communication and stakeholder management 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.
- Build relationships with internal and external stakeholders to support governance.
- Lead analytical investigations, deviations and troubleshooting activities.
- Drive continuous improvement to enhance analytical performance, compliance and efficiency.
- Support analytical method lifecycle activities including transfer, validation and monitoring.
- Manage projects, timelines and deliverables across multiple initiatives.
- Ensure inspection readiness and regulatory documentation supporting product release.
Skills
Education
Tools
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
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.
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.
- 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.
- 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.
- 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.
- Analytical Sciences
- Analytical Testing
- BioAssay
- Collaboration
- Communication
- Cross-Functional Teamwork
- GMP Documentation
- Inspection Readiness
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, 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.
- Employee Status: Regular
- Relocation:
- VISA Sponsorship:
- Travel Requirements:
- Flexible Work Arrangements: Hybrid
- Shift:
- Valid Driving License:
- Hazardous Material(s):
- Job Posting End Date: 10/22/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
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