Scientist I, Protein Manufacturing is responsible for the manufacturing of products and completes associated documentation adhering to standard operating procedures (SOP) and current good manufacturing practices (cGMP). Works with chemicals and biologicals to manufacture or qualify material for IVD use. Participates in process improvement projects.
What will you do?
• Manufactures conjugated micro concentrates and buffers following cGMPs.
• Purifies conjugated micro concentrates on the Microgon diafiltration systems.
• Determines products weighted size distribution using Disc Centrifuge technique.
• Performs analytical and functional testing of conjugated micro concentrates.
• Weighs, transfers, and mixes required chemicals.
• Reviews in-process and completes batch records.
• Participates in daily standup meetings or scheduling meetings.
• Participates in weekly lab clean-ups and expired material segregations, and monthly cold box clean-ups.
• Maintains and orders lab supplies as needed.
• Maintains and analyzes lot histories for trends and discrepancies.
• Maintains, troubleshoots, and validates equipment as appropriate.
• May participate in process improvement projects such as updating processes and/or equipment to improve efficiencies and support business needs.
• May write, review, or modify SOPs, work instructions, and reports with guidance.
• Keeps department manager updated on all issues.
• Performs other job duties as required.
How will you get here?
• Applicants should have a BA or BS degree in Biology, Molecular Biology, Biochemistry, or equivalent
• 0-2 years of laboratory experience. Experience can be derived from internships or positions held post-graduation.
• Hands-on experience with Microgon diafiltration system, Disc Centrifuge technique, and spectrophotometer is desired.
• Laboratory skills and knowledge of safety precautions are a plus.
• Experience in working with potentially hazardous chemicals and human source materials is a plus.
Knowledge, Skills, Abilities
• Must have excellent math and working knowledge of the metric system (weights & volumes).
• Intermediate word processing and spreadsheet software skills with excellent oral and written communication skills. Good interpersonal skills.
• Individuals must work well in a team environment and be adaptable to changes in priorities.
• Self-motivated, independent, and strong critical thinking.
• Must be organized and detail-oriented to be able to prioritize own and others work and meet business productivity metrics.
• Familiarity with Quality System Regulations: cGMP/GDP, ISO, and IVD regulations is a plus.