Zhelun

About Zhelun

Pharmaceutical development leader with 11+ years of experience in CMC drug product development across oral and topical dosage forms within GMP and CDMO environments. Proven track record guiding programs from formulation design through scale-up, technology transfer, and validation support, while partnering with Regulatory Affairs to enable IND and commercial readiness. Recognized for strong cross-functional leadership, aligning formulation strategy, process robustness, and manufacturing execution to deliver complex development programs. CORE COMPETENCIES · CMC Drug Product Development o Oral Dosage (tablets, capsules, films) o Topical Dosage (ointment, spray)· Cross-Functional Leadership o Formulation & Manufacturing Oversight o QA / QC / Regulatory Coordination· Stakeholder & Vendor Relationship Management· Risk Assessment & Mitigation Planning· 505(b)(2) Candidate Screening & Lifecycle Strategy o Market & clinical pipeline opportunity assessment o Dosage form innovation for differentiated 505(b)(2) positioning· High-Complexity Custom CMC Program Execution o Rapid Team Build & Workforce Training· Process Scale-Up & Tech Transfer o 4kg – 180kg Single Batch Size o Inter-Site Tech Transfer (Transfer-In / Transfer-Out)· Validation & Commercial Readiness Support o Material Procurement o Equipment IQ/OQ/PQ· QbD / DoE Implementation· Stability & Control Strategy Alignment· CMC Regulatory Documentation Support· Controlled Substances & HPAPI Experience

Experience

1. Product Development Manager

   Austarpharma

   Jun 2023 — Present · Edison, NJ, US

   Lead CMC drug product development activities for generic, NDA and IND (505(b)(2)) programs including IR tablets and capsules, modified-release tablets and capsules, fast dissolving oral films, ointment• Define formulation strategy and oversee process development from lab scale to pilot and registration batches• Support technology transfer to manufacturing and validation activities to ensure process robustness and GMP readiness• Prepare and compile drug product CMC documentation (Module 3 sections) for Regulatory Affairs review in support of IND and global submissions• Collaborate with Regulatory, QA, QC, and Manufacturing teams to ensure alignment with submission and commercialization timelines• Oversee vendor technical evaluation and development milestone tracking• Support CTM manufacturing, packaging coordination, and stability planning

Education

• New Jersey Institute of Technology

  Master’s Degree, Chemical Engineering

  2012 — 2014

• Shanghai University

  Bachelor’s Degree, Chemical Engineering

  2008 — 2012

Skills

• Microsoft Office
• Powerpoint
• Microsoft Word
• Microsoft Excel
• Matlab
• Research
• Chemistry
• Leadership
• English
• Teamwork
• Windows
• Engineering
• Data Analysis
• High-Performance Liquid Chromatography (Hplc)
• Research and Development (R&D)
• Formulation
• Pharmaceutical Industry
• Laboratory Skills
• Gmp
• Validation
• Standard Operating Procedure (Sop)
• Minitab
• Mandarin
• Laboratory Equipment
• Trackwise
• Form Weigh
• Documentum
• Eroom
• Sigmaplot
• Originlab
• Polymath