Responsibilities
- Utilize expertise in biomolecular separation methods to aid in developing, refining, and resolving issues in analytical processes
- Assist in setting up, growing, and improving analytical and quality control laboratories for both non-GMP and GMP-compliant testing operations
- Create, refine, and carry out analytical testing methods, covering development, qualification, validation, transfer, and product assessment
- Manage the full lifecycle of analytical methods, including writing and reviewing protocols, reports, and technical records
- Support the lifecycle management of standard procedures by drafting and evaluating SOPs and related documentation
- Conduct and interpret diverse analytical tests, such as UPLC/HPLC, CE-SDS, and analytical ultracentrifugation
- Lead initiatives to improve analytical processes by increasing assay reliability, efficiency, and data accuracy
- Evaluate complex analytical data and clearly present findings, insights, and suggestions to internal teams and external partners
- Work closely with cross-functional groups in process development, manufacturing, and quality to advance product and process goals
- Carry out additional assigned tasks as required by operational demands
- Travel up to 15% of the time to support CDMO initiatives or business development efforts
Requirements
- Master’s degree with at least two years of relevant industry experience, or Bachelor’s degree with five or more years, or Ph.D. with applicable experience
- Degree in Chemistry, Biochemistry, Molecular Biology, or a related scientific discipline
- Direct experience with analytical methods including UPLC/HPLC, CE-SDS, and/or AUC
- Proven ability to perform assays following SOPs and protocols in regulated or controlled settings
- Strong problem-solving capabilities and the ability to work both independently and in teams within a dynamic environment
- Knowledge of Good Documentation Practices, Data Integrity principles, and ALCOA+ guidelines
- Excellent interpersonal, verbal, and written communication abilities
- Proficiency with Microsoft Office applications
Nice to Have
- Prior experience in gene or cell therapy development
- Familiarity with MALS or CAD detector technologies
- Experience using Next-Generation Sequencing (NGS) methods
- Background in statistics, coding, programming, troubleshooting, or data management software
Other
Travel up to 15% of the time to support CDMO projects or business development activities
