Associate Scientist, Analytics

Artis BioSolutions•Watertown, MA
•Onsite

About The Position

Artis BioSolutions is recruiting an Associate Scientist to contribute to both Analytical Development and GMP Quality Control for a portfolio of cell and gene therapy products, including CAR-T, iPSC, AAV, LVV, and synthetic DNA. The role involves specialized laboratory testing and supporting the development, qualification, and implementation of analytical methods for clinical GMP release and product characterization. The Associate Scientist will perform key analytical tasks in a collaborative environment and work cross-functionally to support the safety, purity, and quality of patient therapies. The position is hands-on and laboratory-based in a cGMP manufacturing environment. The scientist will develop, optimize, troubleshoot, and execute analytical methods; support transfer of assays from development to Quality Control; and prepare method development and qualification documentation. Candidates will focus on two or more analytical modalities, which may include UHPLC, PCR-based assays, cell-based and proteomic assays, nanoparticle characterization, and laboratory automation. The role requires flexibility to align with cell and gene therapy manufacturing schedules. Artis BioSolutions requests a resume/CV and brief cover letter addressing relevant hands-on techniques and familiarity with applicable cGMP and regulatory frameworks.

Requirements

  • Bachelor’s degree with at least 5 years of relevant experience, or a Master’s degree with at least 3 years of relevant experience.
  • Relevant experience preferably in a cGMP biotechnology manufacturing setting, ideally in cell and gene therapy.
  • Hands-on experience operating UHPLC platforms such as Agilent or Waters, or PCR platforms, in a research or regulated environment.
  • Working knowledge of molecular biology, biophysical characterization of DNA, RNA, or plasmids, or cell-based/proteomic techniques used in cell and gene therapy.
  • Strong attention to detail, problem-solving, troubleshooting, and communication skills.
  • Ability to prioritize tasks under management guidance while demonstrating leadership and collaboration.
  • Valid, unrestricted U.S. work authorization.
  • Availability to start immediately.
  • Flexibility to align with cell and gene therapy manufacturing schedules.

Nice To Haves

  • Familiarity with compendial methods.
  • Experience in a cGMP biotechnology manufacturing setting, ideally within cell and gene therapy.

Responsibilities

  • Develop, optimize, and troubleshoot analytical methods for evaluating cell and gene therapy safety, identity, purity, strength, and quality.
  • Execute routine and advanced analytical testing in a compliant cGMP manufacturing environment supporting cell therapy, vector manufacturing, and fill-finish operations.
  • Support analytical assay transfer from development to Quality Control, including readiness for verification, qualification, or validation and implementation in clinical manufacturing.
  • Draft method development reports, qualification protocols, and summary reports.
  • Collaborate with Analytical and Process Development, Manufacturing, and Quality Assurance teams to ensure methods meet regulatory and compendial standards.
  • Perform general laboratory upkeep and maintain and troubleshoot instrumentation.
  • Follow EHS standards and complete required GMP training.
  • Maintain accurate electronic lab notebooks and prepare protocols, reports, and GMP-compliant documentation under supervision.
  • Develop and execute analytical methods in two or more technical modalities, potentially including UHPLC, PCR-based molecular assays, cell-based and proteomic methods, nanoparticle characterization, or laboratory automation.
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