01/09/2025 updated
DW
100 % available
Pharmaceutical Consultant with Expertise in CMC, QA/QC, and GMP
Tel-Aviv, Israel
Worldwide
Ph.D.Application Programming Interfaces (APIs)AuditingGood Manufacturing PracticesComplianceConsultingPharmacologyQuality ManagementResearch and DevelopmentRisk AnalysisTechnology TransferQuality ControlModel ValidationMedical MaterialPharmaceutical Development
Pharmaceutical Consultancy
Expertise in pharmaceutical consultancy for DS, DP, and medical devices, covering CMC, QA/QC, GMP audits, and risk assessment.
Drug Development
Experience in branded and generic drug development projects, including formulation development and regulatory submissions.
Quality Control and Research
Proficiency in quality control, research, and development laboratories, with experience in regulatory inspections across multiple countries.
Technology Transfer
Expertise in 3rd parties technology transfer processes for API and drug product projects, particularly in Asian regions.
cGMP Analysis
Skilled in cGMP pharmaceutical analysis in R&D and QC laboratories, including method validation and stability studies.
Regulatory Compliance
Knowledge of drug regulations and experience in education programs for global teams on branded and generic submissions.
Cultural Acumen
Hands-on experience working in Israel, Japan, and Germany, with fluency in multiple languages.
Expertise in pharmaceutical consultancy for DS, DP, and medical devices, covering CMC, QA/QC, GMP audits, and risk assessment.
Drug Development
Experience in branded and generic drug development projects, including formulation development and regulatory submissions.
Quality Control and Research
Proficiency in quality control, research, and development laboratories, with experience in regulatory inspections across multiple countries.
Technology Transfer
Expertise in 3rd parties technology transfer processes for API and drug product projects, particularly in Asian regions.
cGMP Analysis
Skilled in cGMP pharmaceutical analysis in R&D and QC laboratories, including method validation and stability studies.
Regulatory Compliance
Knowledge of drug regulations and experience in education programs for global teams on branded and generic submissions.
Cultural Acumen
Hands-on experience working in Israel, Japan, and Germany, with fluency in multiple languages.
Languages
GermanFluentEnglishNative speakerFrenchBasic knowledgeHebrewNative speaker
Project history
CMC member in a development team for innovative small molecule technology transfer to a CMO in China. Responsibilities include review of analytical methods, technology transfers, and cleaning validation activities.
Providing pharmaceutical consultancy projects across the industry, including optimization of legacy finished dosage forms, GxP/QA/QC assessments, and regulatory strategy for market entry.
Managed a laboratory for testing and release of API production, implemented improvements in processes and quality management.