Daniel Loeven Email & Phone Number

New York, Ny, Us

Center For Biomedical Research

New York, New York

Provide regulatory as well as scientific consultation for pharmaceutical development projects, and maintain Investigational New Drug (IND) files and New Drug Application (NDA) files of the reproductive health portfolio.

I am working on creating, improving and administering quality systems for GMP and GCP compliance for this organization, which is involved in development and manufacture of new technologies including a New Chemical Entity. Our team is preparing to file an NDA for this NCE, and I am working on all CMC aspects leading up to this. I recently completed a project to qualify two new GMP manufacturing areas.

Englewood Laboratories cosmetics contract manufacturer.

Leading a diverse group of 30 BS and MS level Chemists and Microbiologists who are responsible for ensuring the quality of all pharmaceuticals manufactured at Pfizer Brooklyn through Quality Control testing. Leading the QC Laboratory team in larger efforts of technology transfer / Product Transfer to internal and external sites to prepare for site closure, and decomissioning of facility and equipment.

Senior Supervisor, Quality Operations - Pfizer Inc. - Responsible for leading a diverse group of 8 - 11 chemists providing support to production in the areas of instrumental analysis including FT-IR, UV/VIS, Dissolution and Release Rate (Extended Release), Polarimetry, AutoAnalyzer (FIA), HPLC, Cleaning Validation and Particulate Matter analysis.-Provided planning, feedback, coaching and performance evaluation for all direct reports.-Authored and revised key laboratory procedures such as handling Out Of Specification results. Laboratory procedures and specification documents are published in Documentum.-Responsible for review and local approval of analytical procedure change controls.-Member of the Process Validation Committee, reviewed and approved Validation Protocols.

Responsible for providing assurance that all products manufactured at the site were suitable for their intended use throughout their shelf life. This is accomplished through the efforts of the Stability Laboratory Staff. Assure that data and assessments generated by the group for stability materials are complete and accurate. Supervise day-to-day operations of the lab. Recruit the best-qualified new personnel to the lab. Provide training and development, performance planning, coaching, and performance evaluation. Serve as a representative of QA on Project Teams for new products and for new systems under development.

Supervise a group of 8 - 10 BS and MS level Chemists performing analysis of stability samples in support of marketed products and some Phase 3 development products.

Master’S Degree, Drug Regulatory Affairs

Activities and Societies: Member of the Rho Chi Society, the academic honor society in Pharmacy.

Bs, Chemistry