Senior Scientist Bioanalytics

Job Description

We are looking for a motivated Senior Scientist (m/f/d) Bioanalytics with a strong background in large-molecule bioanalysis, including ligand-binding, immunogenicity and MS-based approaches, in support of preclinical development activities for new and existing biologics in animal health.

In this position you will support our Preclinical Development team in Schwabenheim on a full-time , fixed-term basis for 2 years .

This position bridges early-stage research and regulated development by providing robust bioanalytical data and scientific interpretation to support pharmacokinetic, immunogenicity, biomarker, exposure-response and safety assessments, thereby enabling submissions to veterinary authorities such as FDA CVM and EMA/CVMP.

In this exciting role you will:

• Develop and implement bioanalytical strategies aligned with project milestones and regulatory expectations.
• Provide scientific leadership, regulatory expertise, and subject matter expertise in large-molecule bioanalysis within cross-functional teams
• Identify and mitigate risks related to assay performance, comparability, assay transfer to CROs, and study execution.
• Prepare bioanalytical contributions to regulatory submissions and scientific presentations for internal stakeholders and veterinary authorities such as FDA CVM and EMA/CVMP.
• Maintain and expand collaborations with contract research organizations and provide effective oversight to ensure quality, compliance and timely delivery.
• Represent Preclinical Bioanalytics in international, multidisciplinary project teams.

Education / Experience

• Ph.D. in Biochemistry, Biology, Chemistry, Immunology, Pharmacology, or related discipline (or equivalent advanced education)

Experience

• Significant experience in regulated bioanalytics (GLP/GxP environment)
• Strong expertise in large-molecule bioanalysis, including PK/PD assays, immunogenicity assessment
• Proven experience in assay development, validation, and troubleshooting
• Experience with CRO management and external collaborations
• Familiarity with regulatory expectations for preclinical development

Core Competencies

• Strategic thinking and scientific leadership
• Deep regulatory and compliance knowledge
• Strong communication and stakeholder management skills
• Ability to lead cross-functional and global teams
• Problem-solving and risk management

Contract Details

• Duration: Temporary (2 years)
• Location: Schwabenheim
• Full-time, hybrid

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

People with severe disabilities and their equals are given preference if they are equally qualified.

Required Skills:

Analytical Chemistry, Analytical Chemistry, Assay Development, Biopharmaceutics, Clinical Data Interpretation, Cross-Functional Teamwork, Detail-Oriented, Experimentation, Genetic Toxicology, High Resolution Mass Spectrometry (HRMS), Immunoassays, Immunochemistry, Immunogenicity Assays, Immunology, Immunotherapy, Laboratory Techniques, Personal Initiative, Pharmacodynamics, Pharmacokinetics, Pharmacology, Pharmacotherapeutics, Pharmacotherapy, Reviewing Literature, Statistical Analysis, Taking Initiative {+ 2 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
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:

Project Temps (Fixed Term)

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

07/3/2026

*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.

Requisition ID: R402220