Associate Scientist, Analytics

Artis BioSolutions•Watertown, MA

About The Position

At Artis BioSolutions, the Analytics Department supports a portfolio of Cell and Gene Therapy (CGT) products, including CAR-T, iPSC, AAV, LVV, and synthetic DNA. The Associate Scientist will contribute to both Analytical Development and GMP Quality Control by carrying out specialized laboratory testing and supporting the development, qualification, and implementation of analytical methods for clinical GMP release and product characterization. This is a hands-on, lab-based role in a collaborative, fast-paced environment. The Associate Scientist will receive mentorship, lead analytical tasks, and work across teams to support the safety, purity, and quality of therapies. The role requires flexibility to align with cell and gene therapy manufacturing schedules. Candidates will focus on two or more analytical areas: UHPLC-based methods; PCR-based molecular assays; cell-based and proteomic methods; advanced nanoparticle characterization; and laboratory automation and emerging technologies. The position includes method development and troubleshooting, routine and advanced cGMP testing, assay transfer to Quality Control, technical writing, compliant documentation, and laboratory operations.

Requirements

  • Bachelor’s degree with at least 5 years of experience, or a Master’s degree with at least 3 years of relevant experience.
  • Relevant experience preferably in cGMP biotechnology manufacturing, 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 CGT.
  • 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 and availability to start immediately.
  • Flexibility to align work with cell and gene therapy manufacturing schedules.

Nice To Haves

  • Experience in a cGMP biotechnology manufacturing setting, ideally within cell and gene therapy.
  • Familiarity with compendial methods.
  • Hands-on experience with one or more of the listed modalities and platforms, including UHPLC, qPCR, dPCR, ddPCR, cell culture, flow cytometry, western blotting, electrophoresis, ELISA/plate readers, nanoparticle characterization, laboratory automation, Ella, BioFire, Fragment Analyzers, or TapeStation systems.

Responsibilities

  • Develop, optimize, and troubleshoot analytical methods to evaluate CGT safety, identity, purity, strength, and quality.
  • Execute routine and advanced analytical methods in a compliant cGMP manufacturing environment supporting cell therapy, vector manufacturing, and fill-finish operations.
  • Support transfer of analytical assays from development to Quality Control and help ensure methods are robust for verification, qualification, or validation and clinical manufacturing implementation.
  • Support drafting 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; maintain and troubleshoot instrumentation; comply with EHS standards; and complete required GMP training.
  • Maintain accurate electronic lab notebooks and prepare protocols, reports, and GMP-compliant documentation under supervision.
  • Depending on analytical focus, develop and troubleshoot UHPLC methods for purity and residual analysis; develop qPCR, dPCR, or ddPCR assays; contribute to cell-based, flow cytometry, and proteomic assays; perform nanoparticle and extracellular-based assays; or implement automated laboratory and molecular workflows.
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