Scott Fredricksen Email & Phone Number

North Chicago, Illinois, Us

Technical leader for commercial process technical transfer, process validation, CMC/PAI support; design and implement data tracking/trending processes for Continuous Process Verification (CPV); created in-house MS Excel method for chromatography transition analysis reporting Non-Gaussian HETP, Gaussian HETP and asymmetry; successfully led PV, PAI efforts for TPM resulting in FDA approval; manager for multiple reports (Master's and BS level) for process development and analytical support for Cell Culture group; leading CI initiative to bring new technology into production facility; certified for all CAPA roles; created excellent, effective communication networks with critical manufacturing groups. Conceived, implemented novel spectrophotometric assay for benzyl alcohol using variable path length technology (VPE).

Directed Capture and Fine Purification Section of Technical Operations laboratory (M.S. and B.S. scientists) supporting monoclonal antibody manufacturing for blockbuster biologic Adalimumab (finished as HUMIRA®); led Tech Support team for start-up and initial process validation of new biotechnology facility (ABL); led technical transfer effort for Downstream Purification at ABL, process improvement initiatives; led process investigations through CAPA system; provided technical support to CMC group for regulatory filings and PAI audit, Quality Control laboratories, Manufacturing group, and Instrument Controls software groups. Successfully led Downstream Purification team per 6-Sigma project and was recognized by CEO for process optimization that resulted in >$1,000,000 per year standard cost savings.Invited speaker at 3rd Caribbean Biotechnology Congress, Mayaguez, PR, Sept. 2006.

Performed equipment FAT, IQ, OQ, PQ for new biologics manufacturing facility; authored new documents (SOP, Batch Record, Chromatography column packing, HETP testing) for Technical Transfer/Scale-up of Adalimumab manufacturing process from Worcester, MA site to Puerto Rico; created new procedures as required to accommodate new equipment configurations; provided process expertise for Instrument Controls group in writing of DCS software for instrument operation.

Abbott Park, Illinois, Us

Greenville, Nc, Us

Dept. of Biochemistry and Molecular BiologyAmerican Heart Association Fellow

B.S., Chemistry

Education record

Ph.D., Biochemistry

Medical Life Sciences