Location/Division Specific Information
Thermo Fisher Scientific – NDX (Legacy Microgenics) 46500 Kato Road, Fremont, CA Part of Clinical Diagnostics Division of Specialty Diagnostics Group
How will you make an impact?
The Scientist III, Protein Manufacturing is responsible for manufacturing of products and completes associated documentation adhered 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 protein conjugates, fragmentation of BSA by pepsin, and buffers following cGMPs.
- Purifies protein conjugates on HPLC, FPLC and size-exclusion chromatography.
- Performs fragmented BSA and buffer filtrations.
- Represents Protein group in cross-functional meetings, understands conjugate scheduling, and supports material qualifications.
- Completes variance and non-conformance investigations.
- Updates documents via MasterControl DCO and MOC.
- Performs analytical and functional testing of conjugates and fragmented BSA.
- Weighs, transfers, and mixes required chemicals.
- Approves batch records and receives materials in QAD
- Initiates and/or participates process improvement projects such as updating processes and/or equipment to improve efficiencies and supports business needs.
- Leads and trains other chemists on equipment and procedures.
- Writes, reviews, or modifies SOPs, work instructions and reports with guidance.
- Maintains and analyzes lot histories for trends and discrepancies.
- Maintains, troubleshoots, and validates equipment as appropriate.
- 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
- A minimum of 4+ years of laboratory experience. Experience can be derived from internships or positions held post-graduation.
- Hands on experience with HPLC, FPLC, BioTek, and spectrophotometer is desired.
- Laboratory skills and knowledge of safety precautions is 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.
- Individual must work well in a team environment and be adaptable to changes in priorities.
- Self-motivated, independent, and strong critical thinking.
- Strong lab skills and knowledge of safety precautions.
- Must be organized and detail oriented to be able to prioritize own and other’s work and meet business productivity metrics.
- Familiarity with Quality System Regulations: cGMP/GDP, ISO and IVD regulations is a plus.
- Manual dexterity. Must be able to lift 25 lbs routinely. May be required to lift up to 50 lbs occasionally.