Paul Freidhoff

About Paul Freidhoff

As a Study Manager at Merck KGaA, my focus is on pioneering analytical methodologies for CGT and other novel modalities. I manage a team of over a dozen talented analysts and lead studies from implementation to data reporting. I also work in project management and work in C2C to communicate with business partners and clients. My skills are bolstered by my PhD in Biochemistry from the University of the Sciences in Philadelphia.My core competencies in genomic assays including PCR and sequencing at University of the Sciences and Merck Sharp Dohme, as well as my experience with separation techniques like HPLC and project management at Johnson & Johnson and Merck KGaA, underscore my commitment to improving biologic identification processes including my work in qualification and validation that led to FDA approval of Rybrevant and FDA approval of Tremfya for Chrom\'s Disease. Championing innovation in the biopharmaceutical field, I leverage my computational acumen, laboratory, and leadership expertise to contribute to groundbreaking research and helping businesses build and maintain business pipelines.

Experience

1. Study Manager Analytical Development Product Characterization

   MilliporeSigma

   Feb 2025 — Present · Rockville, MD, US

   Managed studies and delegated studies to scientists and technicians in a department of over a dozen analysts for GMP and GLP studies. Consulted on custom protocols and ran analytical protocols including DLS, SEC, SCX, CEX, peptide mapping, LC-MS, HILIC, N-Glycan, RP-HPLC, CGE, cIEF, and CZE. Managed entities of various modalities including gene therapies, viral vectors, gene editing vectors, antibodies, multi-specifics, ADCs, and RNA. Reviewed data for clients. Collected and interpreted data to determine trends on instrument quality to prevent quality issues. Developed program in visual basic applications to automatically schedule employees based on arrays of resources. Collaborated with technical writing and QA to implement and improve processes in studies and data management. Worked in project management to establish and meet deadlines as well as communicated to clients for projects. Investigated events, determined proper CAPAs, and wrote C2Cs.

Education

• University of Pittsburgh

  Bachelor's Degree, Biochemistry

  2011 — 2014

• Saint Joseph's University Philadelphia College of Pharmacy

  Doctor of Philosophy - PhD, Biochemistry

• University of Pittsburgh

  Pitt Summer Edge Program in Biomedical Research

  2014 — 2014