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Associate Scientist

Job in Rockville, Montgomery County, Maryland, 20850, USA
Listing for: Merck KGaA
Full Time position
Listed on 2026-02-19
Job specializations:
  • Science
    Medical Science, Research Scientist
Job Description & How to Apply Below
Position: Associate Scientist 3
Work Your Magic with us! Start your next chapter and join Millipore Sigma.

Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet.

That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

Your Role:

As an Associate Scientist 3, your activities will support manufacturing through commercial application of new and innovative service offerings within the biosafety testing space. You are responsible for the scientific integrity of technical work performed in the laboratory, and are required to make scientific observations, maintain detailed workbooks/documentation and ensure all documentation fulfills generally accepted professional/industry standards. You will serve as the SME for closed‑system manufacturing and closed‑system workflows, independently execute and optimize aseptic manufacturing in ISO‑classified clean rooms and client manufacturing under GMP conditions, perform end‑to‑end traditional and closed‑system experience cell culture (mammalian and insect), develop scalable processes for sensitive and stem‑derived lines, maintain audit‑ready ELN documentation, lead deviation/CAPA investigations and deliver operator training-bringing vast cell maintenance & expansion skills and strong alignment with Quality.

Essential Job Functions:

* Independently execute and optimize aseptic manufacturing processes in ISO‑classified clean rooms and client GMP manufacturing laboratories, ensuring compliance with regulatory and safety requirements.

* Perform end‑to‑end traditional and closed‑system mammalian and insect cell‑culture manufacturing, including scale‑up, harvest.

* Serve as the SME for closed‑system cell‑culture workflows, troubleshooting and resolving assembly, connection and control‑system issues to restore aseptic integrity and production continuity; adapt culture conditions, feeding strategies and automated control setpoints to enable reliable expansion of challenging cell lines in single‑use closed formats.

* Develop and optimize scalable closed‑system cell‑expansion processes for sensitive and stem‑derived cell lines: lead process characterization, define critical process parameters, demonstrate reproducible yields and product quality across scales, and drive adoption of closed‑system methods into GMP manufacturing.

* Maintain complete, audit‑ready process documentation in the Electronic Lab Notebook (ELN) in accordance with Good Documentation Practices (GDP) and applicable cGxP requirements.

* Lead investigations of process deviations and nonconformances; perform root‑cause analysis and implement corrective/preventive actions using BRIQS to drive sustained process reliability.

* Execute and document GCC and performance qualification (PQ) activities in BRIQS, ensuring protocol adherence, traceability, and successful qualification outcomes.

* Design, author and validate client‑specific batch/production records, SOPs and C2C‑related documentation; manage client communications to align manufacturing execution with client specifications and regulatory expectations.

* Culture and expand challenging cell lines (including pluripotent and other sensitive primary/stem cells) using feeder‑free and defined media systems while preserving viability.

* Develop and deliver hands‑on training programs and assess operator competency.

* Perform aseptic fills and controlled cryobanking for master and working cell banks, including sterility controls, fill documentation and chain‑of‑custody management.

* Drive continuous improvement by analyzing process performance metrics and proposing technical improvements.

Who You Are

Minimum Qualifications:

* Master's Degree in a scientific discipline (e.g., Biology, Chemistry, Biochemistry, etc.) with 1+ years of laboratory/ industry experience

* Bachelor's Degree in a scientific discipline (e.g., Biology, Chemistry,…
Position Requirements
10+ Years work experience
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