Jen Lutton
Biotech Quality Control Professional Focused on Raw Materials
- Role
- Senior Manager, Qc Raw Materials at Just - Evotec Biologics
- Location
- Seattle, WA, US
- LinkedIn followers
- 500 followers
About Jen Lutton
SKILLSRaw materials inspection, sampling, testing, and disposition for commercial biopharmaceutical manufacturing. Supervision and Training of staff. Raw material and vendor qualification. Technical writing. Cost assessment. Data review. cGMP, SAP, HPLC, ELSD, UV/Vis, Photo-Diode Array, FTIR, TOC (Total Organic Carbon), titration, KF (Karl Fischer), GC, dissolution, viscometry, polarimetry. Pipetting, thin layer chromatography (TLC), cell culture, SDS-PAGE, isoelectric focusing (IEF,) cellulose acetate electrophoresis, ELISA, LAL (endotoxin testing, gel clot), DNA sequencing, Western blot, PCR. USP/NF and ACS methods. Analytical method development and validation. Thermo-Nicolet OMNIC. Agilent Chemstation, Waters Empower, Perkin-Elmer Turbochrom, Shimadzu Class VP. LIMS. Cell culture, radioactivity handling, Biohazard Level 2/3. CPR and First Aid.
Experience
Senior Manager, Qc Raw Materials
Aug 2022 — Present · Redmond, WA, US
Ensure raw materials and components are inspected, sampled, and tested as per approved procedures, and meet specifications. Recruit and train staff. Collaborate with NPI teams to specify new materials. Revise raw material specifications in support of material qualification / commercial readiness. Emergency Response Team and Safety Committee member.
Education
The College of New Jersey
Bachelor of Science - BS, Chemistry
Skills
- Quality Auditing
- U.s. Food and Drug Administration (Fda)
- Data Review
- Hplc
- Training Delivery
- Quality Management
- High-Performance Liquid Chromatography (Hplc)
- Quality Control
- Raw Materials
- Gmp
- Supplier Sourcing
- Employee Training
- Validation
- Gc-Fid
- Technical Training
- Sop Development
- Conductivity
- Technical Writing
- Lims
- Biopharmaceuticals
- Supplier Performance
- Laboratory Information Management System (Lims)
- Supplier Risk Management
- Ftir Microscopy
- Standard Operating Procedure (Sop)
- Report Writing
- Technical Documentation
- Usp
- Water Quality
- Supervisory Experience
- U.s. Pharmacopeia (Usp)
- Sop Authoring
- Analytical Chemistry
- Staff Supervision
- Ftir
- Uv/Vis
- Uv/Vis Spectroscopy
- Batch Release
- Supplier Evaluation
- Toc
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