At Artis BioSolutions, our Analytics Department powers the advancement of a cutting-edge portfolio of Cell and Gene Therapy (CGT) products, including CAR-T, iPSC, AAV, LVV, and synthetic DNA.
We are immediately recruiting a highly motivated Associate Scientist to dual-impact our Analytical Development and GMP Quality Control teams. In this role, you will execute specialized laboratory testing and contribute directly to the development, qualification, and implementation of methods for clinical GMP release and product characterization.
Working in a high-velocity, collaborative environment, you will receive expert mentorship, lead key analytical tasks, and partner cross-functionally to ensure the safety, purity, and quality of life-saving patient therapies.
Key Responsibilities
- Method Development & Optimization: Develop, optimize, and troubleshoot analytical methods to evaluate CGT safety, identity, purity, strength, and quality.
- Routine & Advanced Testing: Execute routine and advanced analytical methods within a fast-paced, compliant cGMP manufacturing environment to support cell therapy, vector manufacturing, and fill-finish operations.
- Tech Transfer & Implementation: Support analytical assay transition from development to Quality Control, ensuring methods are robust enough for verification/qualification/validation and successful clinical manufacturing implementation.
- Technical Writing & Documentation: Support the drafting of comprehensive method development reports, qualification protocols, and summary reports to ensure data integrity and full regulatory readiness.
- Cross-Functional Collaboration: Partner closely with Analytical/Process Development, Manufacturing, and Quality Assurance (QA) teams to ensure methods meet regulatory and compendial standards.
- Lab Operations & Safety: Perform general lab upkeep, maintain and troubleshoot instrumentation, comply with EHS standards, and complete required GMP training.
- Documentation & Compliance: Maintain accurate, reliable electronic lab notebooks (ELNs) and generate protocols, reports, and GMP-compliant documentation under supervision.
Technical Focus Areas
(Candidates will focus on two or more of the following analytical modalities)
- UHPLC-Based Methods: Develop, optimize, and troubleshoot chromatography techniques (e.g., RP, ion-pair, SEC) for purity and residual analysis of small molecules, DNA, RNA, and CGT process residuals.
- PCR-Based Molecular Assays: Design and optimize qPCR, dPCR, and ddPCR methods for drug substance and drug product testing, including gene expression, identification, vector copy number enumeration and compendial applications like Mycoplasma detection.
- Cell-Based & Proteomic Methods: Contribute directly to assay development using advanced cell-culture techniques. Utilize cell counters and flow cytometry for immunophenotyping, cytotoxicity assays, and phenotypic characterization. Apply core molecular biology and proteomic approaches including western blotting, electrophoresis, and ELISA/plate-reader platforms.
- Advanced Nanoparticle Characterization: Develop and execute nanoparticle and extracellular-based assays utilizing specialized instrumentation, including advanced particle counters and nanoflow cytometers.
- Laboratory Automation & Emerging Technologies: Implement high-throughput laboratory automation and automated molecular workflows. This includes leveraging the automated microfluidic immunoassays (Ella Platform) to minimize operator variability, the BioFire platform for rapid and automated molecular Mycoplasma detection, and advanced nucleic acid analysis platforms including Fragment Analyzers, TapeStation systems.
Required Experience & Qualifications
- Education & Experience: Bachelor’s degree with 5+ years of experience or a Master’s degree with 3+ years of relevant experience (preferably in a cGMP biotechnology manufacturing setting, ideally within cell and gene therapy).
- Instrumentation Mastery: Hands-on experience operating UHPLC platforms (Agilent, Waters) or PCR platforms in a research or regulated environment.
- Technical Knowledge: Working knowledge of molecular biology, biophysical characterization (DNA/RNA/plasmids), or cell-based/proteomic techniques used in CGT. Familiarity with compendial methods is a plus.
- Professional Attributes: Detail-oriented with strong problem-solving, troubleshooting, and communication skills. Ability to prioritize tasks under management guidance while demonstrating leadership and collaboration.
- Work Authorization: Must possess valid, unrestricted U.S. work authorization and be available to start immediately.
- Role Logistics: This is a hands-on, lab-based role requiring flexibility to align with cell and gene therapy manufacturing schedules.
To Apply
Please submit your resume/CV and a brief cover letter. Your cover letter must specifically address:
- Your hands-on experience with the relevant techniques listed above.
- Your familiarity with the cGMP and regulatory frameworks applicable to CGT analytical testing.
Artis BioSolutions is an Equal Opportunity, Affirmative Action employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply.
