Jerry Sparks

About Jerry Sparks

Over twenty years of experience in drug product formulation and process development, manufacturing support, and process improvements for biologic and small molecule parenterals.Led and supervised leaders of Drug Product (DP) CMC teams consisting of members from the Device & Packaging, Pharmaceutics, Analytical, Manufacturing, Quality, and CMC Regulatory. Teams made strategic project recommendations, developed technical solutions, and oversaw the execution of activities, for formulation and process development.Responsible for project management and technical support of CRO/CMO activities, including establishing project scope, schedule of activities, contract terms & requirements, and adherence to budgets up to $3.0 million annually, as well as ensuring deliverables for project strategies and milestonesExperience in liquid and lyophilized formulation development for fusion proteins and mAbs assessed via biochemical (SEC, cIEF) and biophysical (visible, subvisible particles) assays. Formulation studies involving pH, buffer, and surfactant screening, as well as long term stability studies. Drug product development included simulated intravenous in-use delivery studies for low and high dose proteins, compatibility with closed-system-transfer-devices (CSTD), as well as primary container selection. Experience in drug product process characterization and technology transfer for both protein and small molecule liquid, emulsions and lyophilized formulations. Processes included bulk protein freeze / thaw, compounding / liquid mixing, sterile filtration, vial / syringe filling, visual inspection, and transportation / cold chain management of parenterals. Small molecule high-shear emulsion mixing, as well as bottle/tip/cap and blow-fill-seal filling. Reviewed and/or participated in process FMEA risk assessments, process control strategies, and drug product process validation protocols.Designed and scaled-up lyophilization cycles for clinical production as well as technology transfer. Provided support for a unique high alcohol / solvent content small molecule lyophilization process.Experience in the product life-cycle management, including cGMP manufacturing support, recommendation of alternative vial & pre-filled syringe presentations for new indications as well as the implementation of alternative sources of key raw materials.Experience in authoring drug product CMC sections for clinical IND/IMPD filings.Supervisory experience managing the goals, project priorities, and resource needs of associates/engineers (BA/BS/MS) & scientists (Ph.D.).

Experience

1. Executive Director, Biologics Drug Product

   Disc Medicine

   Jun 2025 — Present · Orange County, CA, US

Education

• Rensselaer Polytechnic Institute

  Ph.D., Chemical Engineering

  1992 — 1999

• University of Delaware

  BChE, Chemical Engineering

  1988 — 1992

Skills

• Contract Manufacturing
• Formulation
• Director Drug Product Development
• Compounding
• Ind / Nda / Bla / Emea / Ctd Regulatory Filings
• Regulatory Submissions
• Monocl
• Protein Formulation and Stability
• Biotechnology
• Cmc Drug Product Development
• Sterile Filtration
• Emulsion Process Development
• Technology Tra
• Biologics
• Sterilization
• Regulatory Affairs
• Gmp
• Cmc Team Leader
• Syringe
• Pre-Filled Syringes
• Smal Molecule Parenterals
• Monoclonal Antibodies
• R
• Drug Development
• Technical Strategic Development
• Biopharmaceuticals
• Department Supervision and Budgeting
• Drug Product
• Fda
• Clinical Development
• Technical Leadership
• Quality by Design
• Lyophilization
• Drug Pro
• Blow-Fill-Seal
• Validation
• Mixing
• Drug Delivery
• Technology Transfer
• Vial Filling