The Lateral Flow Production Senior Analyst is a mid-level, non-exempt position that reports to the Lateral Flow Production Management Team. The Lateral Flow Production Senior Analyst supports Management by aiding Analysts in the manufacture of Charm ROSA diagnostic tests for screening in the dairy and/or grain industry.
• Analyze and approve new lots or purifications of reagents for use in a wide range of ROSA diagnostic tests. Communicate results to Raw Materials department.
• Assist analysts in determining proper titrations of raw materials to ensure that all specifications are met.
• Aid in the improvement of new as well as current ROSA diagnostic tests.
• Organize and verify the accuracy of documentation of SOP’s for raw materials. File completed records for future reference.
• Create SOP’s as well as spreadsheets that include templates for clear and accurate data presentation.
• Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
• The Lateral Flow Management team will provide a schedule on a daily/weekly basis. The scheduled assigned tasks need to be accurately completed by the due date.
• A Senior Analyst must possess the ability to take a lead role in the manufacture of more difficult, shorter incubation time tests, and for suggesting improvements in the processes.
• Evaluates and approves the lamination of product to be sent to packaging when needed.
• Must have strong interpersonal skills; be diligent and dependable with excellent attention to detail.
• Responsible for monitoring current inventory of assigned ROSA diagnostic tests and ensuring that orders are filled in a timely manner.
Knowledge, Skills & Abilities
• BS or equivalent in Biochemistry or related field.
• 2+ years of Lateral Flow diagnostic test manufacture experience.
• Proficiency with MS Excel, Word and Outlook
• Strong understanding of statistics
• Excellent verbal and written communication skills.
• GMP/GLP Experience.
• Five years experience in a biotech manufacturing or related field.
• Must possess dexterity to frequently and accurately operate pipettes every day.
• Must be able to remain in a stationary position for an extended length of time; 60-90 minutes on average.
• Must be able to visually inspect and label spraying defects on a moving component web on a reel to reel machine.
• Must be able to safely handle antibiotics in dry powder and concentrated liquid form in a laboratory setting.
• Will be exposed to fluctuating environmental conditions, i.e. temperatures ranging from 4°C in a walk-in cold-room where finished product is stored to 28°C in reel to reel spray room.