Analytical & Bioassay Lab Scientist (Full-/Part-time) (all genders)
Merck GroupJobsCloseBy Editorial Insights
Merck Group is hiring an Analytical & Bioassay Lab Scientist (full or part time, onsite in Darmstadt) for BioReliance CTS. The role covers routine GMP assays, product characterization and lot release, lab organization, reagent prep, equipment maintenance, and mentoring junior staff. You will act as Responsible Scientist, drive deviations and CAPA closures, initiate Change Controls for new services, and contribute to audits and SOPs. Requirements: bachelor’s or higher in life sciences, GMP-lab experience, data trending, SOP authoring, strong documentation and communication, cross-functional collaboration, ability to manage multiple priorities; familiarity with ICH, FDA, EMA is a plus. Application tips: tailor your resume to highlight CAPA, Change Controls, training, and mentoring, quantify impact, and show your fit with an inclusive culture and the mission to spark discovery.
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About CTS
Choosing the right partner for analytical and biosafety testing is crucial in the race for regulatory approval. Our BioReliance® contract testing services deliver robust, risk-mitigating solutions backed by deep technical and regulatory expertise to help bring life-changing medicines to market.
Your role
The Lab Scientist at BioReliance Contract Testing Services performs a broad range of routine GMP-compliant lab tasks to support testing operations. This role includes conducting essential assays for product characterization and lot release, maintaining lab organization, preparing reagents, managing stock, and ensuring equipment maintenance. The Lab Scientist also trains and mentors junior staff, assumes responsible scientist duties for routine GMP studies, leads root-cause investigations, and provides scientific and technical support for laboratory studies.
Key Responsibilities
- Act as Responsible Scientist for routine GMP assays, ensuring proper conduct of studies.
- Collaborate with the Lab Manager or Senior Scientist to develop testing schedules for laboratory personnel.
- Ensure timely completion of trending spreadsheets and study documentation in accordance with SOPs.
- Lead and drive timely closure of deviations and CAPA (Corrective and Preventive Action) records.
- Initiate and advance Change Controls for the introduction of new services, testing methods, and assay validations.
- Adhere to SOPs and regulatory requirements to ensure studies are completed on time and accurately recorded, meeting scientific and GMP standards.
- Author and maintain laboratory protocols, SOPs, and workbooks; initiate Change Controls for new services.
- Train and mentor junior laboratory personnel.
- Participate in internal Quality Audits and regulatory audits as required.
Who you are
- Bachelor’s degree or higher in a life sciences discipline (e.g., Biology, Chemistry, Microbiology, Biotechnology) or equivalent experience.
- Experience working in a GMP-regulated laboratory.
- Strong understanding of lab processes
- Proficiency with study trending, data management, and SOP authoring
- Excellent documentation, communication, and mentoring skills.
- Familiarity with regulatory expectations (e.g., ICH, FDA, EMA) is a plus.
- Ability to work collaboratively in a cross-functional team and manage multiple priorities.
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!