Dimitry Zelenyuk

About Dimitry Zelenyuk

I am an analytical team leader with strong and diversified technical and scientific knowledge in Analytical Chemistry, Manufacturing and Control (CMC) activities, Quality Assurance and Technical Documentation in advancing small and large molecules from early phases through clinical development and product launch.Proficient with recognized accomplishments in working with cross-functional CMC teams and drug product and analytical development, quality assurance and technical documentation supporting overall drug development process in GI, CNS, Women’s Health, and Ophthalmology therapeutic areas.Solid experience and in-depth knowledge in the following key-areas of expertise- CMC: managed all analytical CMC activities and budgets, representative in project teams, successfully led technology transfers for numerous projects to commercial sites- Drug Product development: led analytical teams in development through various stages of drug product development, vendor selection, DS and DP specifications to ensure product quality, and worked closely with formulators to make key drug product decisions during development and DOE studies for oral, parenteral, and ophthalmic formulations- Analytical Method Development: developed and validated numerous analytical methods to analyze raw materials, drug substances (DS) and drug products (DP). Developed and executed transfer strategies to support product commercialization- Quality Assurance: worked closely with quality assurance teams during setting of DS/DP specifications, issuance of analytical methods, review/disposition of clinical/pilot/registration batches, review/approval of deviations, out-of-trend, out-of-specification (OOS) investigations, implementation of CAPAs and participating in pre and post approval audit inspections (PAI)- Technical Writing: authored numerous analytical documents (methods, memos, justifications, product shelf-life, protocols, reports, stability trends) to support testing of raw materials, DS and DP. Authored CMC module 2 and 3 sections in over 30 individual product applications filed in US and worldwide. As analytical SME, responsible for providing responses to various regulatory agency requests during review/approval of the filed applications- Leadership/Collaboration: led multiple cross-functional project teams, supervised scientists, mentored others in analytical method development/validation/formulation support and product development through collaborations.

Experience

1. Associate Director, Quality Control

   Avidity Biosciences, Inc.

   Jan 2024 — Present · San Diego, CA, US

Education

• California State University, Long Beach

  Bachelor’s Degree, Biochemistry and Chemistry

Skills

• R&D
• Glp
• Gmp
• Pharmaceutical Industry
• Technology Transfer
• Hplc
• Drug Development
• Change Control
• Lims
• Fda
• Dissolution
• Validation
• Pharmaceutics
• Sop
• Capa
• Chromatography
• Analytical Chemistry
• Regulatory Submissions
• V&V
• Regulatory Affairs
• Quality System
• Cleaning Validation
• Chemistry
• Formulation
• Uv
• 21 Cfr Part 11
• Lc-Ms
• Biopharmaceuticals
• Gxp
• Drug Delivery
• Quality by Design
• Gc-Fid
• Operations Management
• Andas
• Cgmp Manufacturing
• Technical Writing
• 483 Responses
• Deficiency Letter Responses
• Uv/Vis
• Bpf