Associate Scientist 3

The businesses of Merck KGaA, Darmstadt, Germany•Rockville, MD

10h•$27 - $52•Onsite

About The Position

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 cleanrooms 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.

Requirements

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, Biochemistry, etc.) with 2+ years of laboratory/ industry experience
Associate’s Degree in a scientific discipline (e.g., Biology, Chemistry, Biochemistry, etc.) with 4+ years of laboratory/ industry experience

Nice To Haves

Experience with GLP, GXP
Advanced skills in applicable computer programs
Excellent oral and written communication skills that have been demonstrated through presentations/seminars, oversight of projects, etc.
Demonstrate expert-level ability to lead complex work both independently and within cross-functional teams
Provide technical guidance, mentoring colleagues, and driving alignment to achieve operational and compliance objectives.
Demonstrates a high level of initiative and leadership capabilities
Highly, technically competent

Responsibilities

Independently execute and optimize aseptic manufacturing processes in ISO‑classified cleanrooms 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.