Analytical Scientist
-
Apply Now Application ends in 26d 21h 57min
Job Detail
-
Offered Salary 0
Job Description
Job Description
As an Analytical Scientist, you will bring hands-on expertise in quality control and molecular biology, focusing on assay development and analytical testing within a GMP setting. You will design, optimize, and execute a variety of cell- and protein-based assays to characterize biologics, supporting product release and stability studies. Proficiency in method qualification and validation, data analysis, and cross-functional collaboration with R&D and manufacturing teams is essential. You will also have a strong understanding of regulatory expectations, with experience in authoring protocols, technical reports, and SOPs.
Responsibilities
- Perform flow cytometry-based QC testing for product characterization, release, and stability studies.
- Conduct additional QC analytical techniques such as ELISA, qPCR, endotoxin testing, cell-based assays, biochemical assays, HPLC-based methodology, and others as required.
- Support GMP-compliant quality control operations, including documentation, sample handling, routine instrument calibration, maintenance, and troubleshooting for analytical instruments.
- Review and maintain accurate, GMP-compliant laboratory records, including SOPs and deviation reports.
- Conduct method qualification and validation following ICH and regulatory guidelines.
- Participate in investigations of out-of-specification (OOS) results and deviations.
- Collaborate with cross-functional teams, including manufacturing, quality assurance, and R&D, to ensure smooth workflow and compliance.
- Maintain a clean and organized laboratory environment following safety and regulatory guidelines.
- Analyze, interpret, and report experimental data with attention to detail and scientific rigor.
- Author and review technical documents including protocols, validation reports, SOPs, and technical summaries.
Essential Skills
- Quality Control
- Molecular Biology
- Assay Development
- Cell-based Assay
- Protein-based Assay
- Flow Cytometry
- ELISA
- qPCR
- Endotoxin Testing
- Biochemical Assay
- HPLC
- Western Blot
- Method Development
- Qualification
- Validation
- Regulatory Compliance
- Bioanalytical Assays
- GMP
- GLP
Additional Skills & Qualifications
- Bachelor’s, Master’s, or Ph.D. in Molecular Biology, Biochemistry, Analytical Chemistry, or related field.
- 2+ years of hands-on experience with flow cytometry in a QC, analytical, or research setting (academic or industry experience acceptable).
- Experience working in a GMP, GLP, or regulated laboratory environment is preferred.
- Hands-on experience with bioanalytical assays such as flow cytometry, ELISA, qPCR, Western blot, cell-based potency assays, or other relevant methods.
- Strong understanding of method development, qualification/validation, and regulatory compliance (FDA/ICH guidelines).
- Strong attention to detail and ability to follow standard operating procedures (SOPs) accurately.
- Excellent documentation and communication skills, with the ability to work effectively in a team-based environment.
- Preferred: Masters with a PhD mindset would be ideal. Some flow cytometry experience is a must-have.
Apply Now
Application ends in 26d 21h 57min