Analytical Development Scientist
- Employer
- List Biological Laboratories
- Location
- Campbell, CA
- Start date
- Jun 29, 2022
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- Discipline
- Information Technology, Business/Data Analytics, Science/R&D, Biotechnology
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Biotech Bay
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Analytical methods development, optimization, validation/qualification, and transfer to QC for routine release and stability testing
• Deep technical and scientific knowledge of analytical technique, software, and instrumentation, such as HPLC, spectrophotometric assays, immunochemical methods, titration assays, SDS PAGE, ELISAs, enzymatic assays, cellular cytotoxicity
• Apply scientific knowledge and/or with collaboration with technical subject matter experts develop separation methods, e.g. RP, IEX, HILIC, SEC and Protein A affinity chromatography for quantitative and qualitative analysis of impurities in drug products
• Adopts and develops next-generation analytical platforms for better characterization and extend our understanding of our products
• Serves as analytical lead in multidisciplinary project teams and/or sub-team meetings within the company or with clients
• Develop, qualify, validate assays/ methods with minimum supervision, write SOPs and transfer methods to QC department as needed
• Design experiments and write protocols for assay development and validation
• Perform assays or supervise other analysts for assay development and validation work
• Analyze experimental data with appropriate statistical tools and report scientific results
• Interpret data and adhere to strict guidelines on documentation when recording data
• Review and/or approve cGMP documentation generated by other analysts in the laboratory if necessary
• Contributes to building a culture that encourages continuous learning, improvement, and innovation, and encourages team members to expand their technical skill base
QUALIFICATION AND EXPERIENCE:
• B.S. or M.S. preferably in biological sciences or related field
• A minimum of 5 + years of relevant experience in Biotechnology or Pharmaceutical industry KNOWLEDGE, SKILLS AND ABILITIES
• Works on complex problems in which analysis of data requires evaluation of identifiable factors
• Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• Is familiar with regulatory guidelines pertaining to assay development, qualification, and validation
• Understands analytical development and uses published literature to extend understanding, as well as consulting internal and external experts as needed
• Ability to generate new experimental proposal built on existing methods or techniques
• Highly independent and self-motivated and integrates well within a team
• Strong ability to trouble-shoot technical problems
• Good organizational skills with ability to meet deadlines and prioritize work on multiple projects
• Excellent oral and written communication skills
• Dedicated, hard-working and dependable
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