Job Description :
Pay Range $53hr - $56hr
Responsibilities :
- Serve as a subject matter expert responsible for developing robust analytical methods and expanding product and process understanding.
- Independently develop and execute bioanalytical or molecular assays (e.g. chromatography, electrophoresis / CE assays).
- Identify issues, lead troubleshooting experiments, and determine solutions with minimal to no guidance.
- Train users on method execution, data analyses, and proper use of instrumentation.
- Lead qualification and transfer of analytical methods to external stakeholders.
- Routinely present work at team, technical team, and department meetings.
- Maintain meticulous laboratory notebooks..
- Analyzing, interpreting, and presenting data to internal and external stakeholders (PowerPoint Presentations).
- Author, review and approve technical documents, including methods, protocols, reports, and SOPs.
- Deliver lifecycle-managed analytical methods for multiple programs with an understanding of ICH / FDA / EMEA best practices and current thinking.
- Facilitate smooth operation of the laboratory, including ordering, assisting in the cryopreservation of cellular material, sample management, etc.
Qualifications and Experience :
- BS, MS or PhD in Molecular Biology, Analytical Biochemistry, Immunology, Microbiology, Cell Biology, or related field.
- PhD with 0-3 years, or MS with 3+ years, or BS with 7+ years of relevant industry experience.
- Proven experience with physicochemical analytical techniques such as chromatography, electrophoresis / CE, etc.
- experience working with Waters UPLC system and Empower software
- Methods : SEC-U / HPLC, SEC-MALS, IEX, RP-LC, Affinity, CE : PA800 (SCIEX) CE-SDS, CZE, cIEF.
- Experience with protein characterization preferred.
- Strong problem-solving ability to troubleshoot complex technical and scientific problems.
- Experience with writing technical and regulatory documents for interdepartmental use and external vendors (e.g., CMO’s).
- Strong attention to detail.
- Outstanding written and oral communication skills.
- Work effectively in a collaborative team setting.
- Ability to work in a rapidly changing environment with frequent changes in priorities.
- Knowledge of immunology and T cell biology as applied to the cell therapy field.
- Knowledge or experience with vector and gene editing analytics (AAV, CRISPR, etc)
- Experience with molecular techniques (e.g., qPCR, RT-qPCR, and / or ddPCR).
- Experience with data analysis and interpretation using software (e.g., Softmax Pro, Gen5, Excel, Prism Graphpad).
- Familiarity with statistical analysis and design on experiments (DoE) using JMP software.
- Track record of successful transfer and management of analytical methods has a context menu.
Skills :
- Proven experience with physicochemical analytical techniques such as chromatography, electrophoresis / CE, etc.
- experience working with Waters UPLC system and Empower software.
- Methods : SEC-U / HPLC, SEC-MALS, IEX, RP-LC, Affinity, CE : PA800 (SCIEX) CE-SDS, CZE, cIEF.
- Experience with protein characterization preferred.
30+ days ago