Daniel Buch Email & Phone Number

St Louis, Missouri, United States

Responsible for the development of quality agreements with MilliporeSigma customers and negotiating directly with global customers to achieve results amenable to both partiesAccountable for ensuring that quality agreement language is in alignment with standard quality procedures and documentation as performed by manufacturing and testing locationsWork with.

Greater St. Louis Area

Provide Quality representation and supervision as client liaison between all internal sub-groups of QA and regulatory for clinical and commercial phased products, ensuring compliance to applicable internal and external regulations (FDA, EMA, ICH guidelines);Perform Quality review of various GMP documentation such as clinical and commercial batch records.

Greater St. Louis Area, MO, USA

Provide guidance from a quality perspective and handle client needs, resulting in successful and on-time release of client clinical products Provide Quality support to manufacturing and technical groups to identify potential compliance issues, manage the investigation of minor/ major/ critical deviations and appropriate follow-up corrective/ preventative.

Greater St. Louis Area, MO, USA

Acts as the liaison between the Client needs,Program management, for both clinical and commercial products. Review/Revise Quality Agreements,IND/IMPD/BLA submission Quality Representation for technology transfer of new clinical or commercial phase products, ensuring development of process adheres to applicable regulations based on phase appropriate FDA.

Intec Pharma Ltd, Jerusalem, Israel

Establishing & conducting more than 20 clinical and pre-clinical studies under strict GCP standards for various therapeutic fields.(CNS, GI,Oncology) Generating & reviewing clinical and regulatory documents including: INDs application. Study Protocol, Clinical Reports, Case Report forms, Informed Consent forms, Annual safety reports, AEs and SAEs reports.

Jerusalem, Israel

• Conducted evaluation of pharmaceutical batch certification analysis to the company’s registered specifications.
• Supporting in the registration process of approval new biological products
• Assessed quality of new pharmaceutical products according to international guidelines (EMEA, ICH, FDA, cGMP, PIC/S)

The Hadassah University Medical Center (Ein Karem), Jerusalem, Israel

• Worked in the central hospital pharmacy that served hospitalization department, research foundations and various other hospitalization units.
• Conducted drug consultation, medical product economic & logistic support, drug preparation based on patient prescriptions

Jerusalem Area, Israel

• Marketed molecular biology products to research and diagnostic laboratories
• Responsible for extending and improving the company client realtionships

Jerusalem Area, Israel

Conducted advanced research in the field of Molecular Biology and Microbiology - Used techniques of recombinant DNA technology, biochemistry, microbiology and chemistry - Developed and implemented policies and procedures throughout the laboratory. Including establishing of plasmid, library screening and bioinformatics method databases Teaching in several.

Bachelor Of Science (B.Sc.), Biology, General

M.B.A., Marketing & Strategy And Entrepreneurship

Courses work emphasis in; Marketing, Entrepreneurship and Business Strategy

Bachelor Of Pharmacy (B.Pharm.), Pharmacy

Courses work emphasis in; Pharmacokinetics, Pharmacodynamics, pharmacotherapy, clinical pharmacology, Pharmaceutical industry.

Master Of Science (M.Sc.), Molecular Biology

Coursework emphasis in Biochemistry, Microbiology, Molecular Biology, Immunology, Molecular Genetic