DONGMEI QIANG

PROFESSIONAL SUMMARY

A passionate and results-oriented CMC leader with a career track record of success in providing strategic planning and technical guidance, and ensuring the timely delivery of high-quality pharmaceutical products to support all stages of drug product development lifecycle. Proactively identify and implement effective process improvements to accelerate development timeline. Led a cross-functional team to complete drug product development, process optimization, scale-up, validation and NDA submission successfully within 4 years from the candidate nomination for an oncology drug. Seeking a full-time position that offers professional challenges utilizing my strong technical expertise in CMC development, great interpersonal skills, excellent project management and problem-solving skills.

CORE COMPETENCIES AND QUALIFICATIONS

• Highly-skilled and experienced in multiple aspects of small molecule CMC development including API polymorph & salt screening/characterization, preformulation, analytical method development/validation, formulation/process development and manufacture, stability evaluation
• Over 20 years of experiences in developing variety of dosage forms (solution, suspensions, liposomes, solid oral dosage forms) to support IND enabling, non-clinical and all phases of clinical studies for different patient populations
• Strong technical expertise in solid oral dosage form development, process scale-up, tech transfer and validation with sound understanding of major processing equipment and unit operations (e.g. Wet and Dry Granulation, Fluid Bed Drying, Compression, Spray Drying, etc. )
• Extensive experiences in collaborating with external CROs/CMOs and depots for drug product development, manufacture, analytical testing, packaging/labeling and distribution to ensure timely delivery of drug supplies meeting all quality standards
• Proficient with QbD concepts and Design of Experiments approaches to support formulation and process optimization. Familiar with statistical tools for data analysis
• Thorough understanding of cGMP principals and practices as well as global regulatory requirements across different product lifecycle. Ensure cGMP compliance and regulatory adherence within the company and contract organizations.
• Highly skilled and experienced in technical report and protocol writing. Author and review regulatory submission documents for CTA/IND/NDA filing as well as Pediatric Investigation Plan (PIP)
• Strong technical expertise in solid oral dosage form development for poorly soluble compounds to improve bioavailability, drug product process development, scale-up, tech transfer and validation with sound understanding of major processing equipment and unit operations
• Proficient with QbD concepts and Design of Experiments approaches to support formulation and process optimization, and validation for both spray dried dispersion (SDD) and finished product
• Extensive experiences in collaborating with external CROs/CMOs for drug product development, manufacture, analytical testing, packaging/labeling and distribution to ensure timely delivery of drug supplies meeting all quality standards
• Thorough understanding of cGMP principles and practices as well as global regulatory requirements across different product lifecycle. Proficient in regulatory document writing for CTA/IND/NDA
• Self-motivated, comfortable in fast-paced small company environment. Highly organized and efficient with strong competencies in influencing and negotiation; Able to handle multiple projects simultaneously with a high degree of accuracy

SKILLS

• Solid oral dosage form development
• Process optimization, scale-up & validation
• Poorly soluble compound enabling
• Bioavailability improvement
• Solid state characterization
• Clinical Supply Chain Management
• IND/CTA and NDA Document Preparation
• Project management
• Cross-functional Team Leadership
• CMO/CRO Management
• Contract Negotiation and Proposal Writing
• Budget Forecasting and Resource Allocation
• Team Building & Talent Recruitment
• SOP and Procedure Development