Gorm Yoder

About Gorm Yoder

SUMMARYPhD analytical chemist with over 20 years industrial experience in Small Molecule Analytical Development/CMC and characterization (including PAT) supporting API process and formulation development – solid experience in oral (solid, prodrug, and liquid), parenteral, combination products, inhalation dosage forms (MDI, DPI, and nebulized products), transdermal products, and other therapeutics (biologics– mAb/ADCs/peptides/hormones/oligonucleotides/vaccines).Broad development and characterization experience with small molecules and bio-macromolecules/biologics [e.g, HPLC/UPLC, IC, GC, Mass Spectrometry (LC-MS, GC-MS, ICP-MS), NMR, achiral/chiral chromatographic methods (HPLC, SFC, GC, CE, cIEF, cSDS, and SE-HPLC), physical methods (DSC, TGA, and PSA), spectroscopic techniques (UV/Vis, FTIR, AA, fluorescence, NIR, Raman, SEM, XRD, CD, VCD, ROA, and LIBS], and bioassay (ELISA, Octet, MSD). Broad experience (and many analytical leadership roles) working within the Small-/Large-Molecule CMC framework both in pre-clinical, early and late development including method development/validation/transfer, specifications (API, raw materials/intermediates/starting materials, and drug product), reference materials, clinical stability/release, impurity identification (incl. forced deg/ASAP modeling), and dossier support/authoring (e.g, NDA/BLA/MAA/IND).Lead/drive scientific strategy in both the CMC and AD R&D framework with a focus on the external innovation space (i.e, disruptive technologies that enable or inform drug development).Support due diligence efforts for licensing and acquisition opportunities in Small-/Large-MoleculeBroad experience in managing internal and external partners within a globally matrixed environment.Represent Analytical Development on various multi-disciplinary project teams. Contribute to strategic and technical decision making in support of R&D studies and commercial product life-cycle initiatives.Possesses strong knowledge of compendial methods and regulatory requirements (i.e. ICH, USP, EP, & JP).Apply QBD, PAT, Modeling/Chemometric, and DOE strategies for process development (API/Drug Product).PUBLICATIONS: 12 publications; 1 PatentAFFILIATIONS-American Chemical Society (ACS)- Member-Society of Applied Spectroscopy (SAS) – Formerly Executive Board Member for Northern California Chapter-Innovation and Quality (IQ) Consortium – Formerly Board member-IQ MPS Affiliate – Formerly Steering Committee MemberLANGUAGES: Foreign Languages spoken: Spanish (fluent), Catalán, Danish.

Experience

1. Analytical Development Lead Small Molecule

   Gates Medical Research Institute

   May 2024 — Present · Cambridge, MA, US

   Responsible for supporting all analytical development CMC activities across the Gates MRI portfolio of drug product candidates from pre-clinical through Phase 3 and licensure.Collaborate with internal process/bioprocess development, clinical, quality and regulatory teams and with external partners.Responsibilities include analytical method development/qualification/validation, reviewing and establishing specifications, analytical support of process development, formulation and drug product development, reference materials, forced degradation studies, impurity assessments (incl. structural elucidation of unknown impurities), analytical testing review, OOS/OOT/deviation investigations, and stability studies.Support establishment and verification of analytical protocols, control strategies for Intermediates/Starting Materials/Raw Materials, Drug Substance, and Drug Product candidates.Applies appropriate statistical tools for the analysis of analytical data.Support of regulatory filings/ queries, including investigational new drugs (INDs)/investigational medicinal product dossier (IMPDs), new drug applications (NDAs).

Education

• University of Barcelona

  None

  1984 — 1985

• Knox College

  B.A

  1982 — 1986

• University of Illinois Chicago

  Ph.D

  1992 — 1997

Skills

• Hplc
• Regulatory Affairs
• Liquid Chromatography-Mass Spectrometry (Lc-Ms)
• U.s. Food and Drug Administration (Fda)
• Validation
• Quality Assurance
• Spanish
• Spectroscopy
• Formulation
• V&V
• Analytical Chemistry
• Ftir
• Technology Transfer
• Chromatography
• Regulatory Requirements
• Ind
• Sop
• Fda
• Glp
• Chemistry
• 21 Cfr Part 11
• Uv/Vis
• Regulatory Submissions
• Pharmaceutics
• Biotechnology
• Lc-Ms
• High-Performance Liquid Chromatography (Hplc)
• Quality Control
• Gmp
• Gas Chromatography
• CRO
• Drug Development