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 internal stakeholders (legal, sales, site quality) to ensure that contracts are completed in accordance with MilliporeSigma defined procedures

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, PPQ protocols, IND/IMPD/BLA submission to ensure cGMP compliance with site procedures , adherence to Quality Agreements, and ICH/FDA guidelinesEstablish new quality agreements for commercial and clinical products

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 actions in compliance with Quality procedures, policies, & regulations Review & approve cGMP documents such as, but not limited to, tech transfer protocols, batch records, SOPs, deviations, product specs and product disposition packets Draft and review Quality Agreements for clinical clients, external contract labs, cGMP service providers; Conduct suite and product changeovers and Quality internal audits, resulting in continuous improvement of site procedures/ activities

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, EMA and ICH guidelinesPerforms quality project management, documentation management between Patheon and client, Assists in transfer and communication on technological transfers , regulatory documents/commitments and adherence to Quality Agreements. Recognized subject matter expert in one or more of the following Quality Assurance areas: cGxP compliance, biopharmaceuticals manufacturing, and regulatory affairs,

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, Investigator's Brochures, lab manuals. Participating in the quality assessed and batch release process of IMPs products, Supervision of products packaging & labeling according to international and local cGMP guidelines.Performed and coordinated all clinical supply logistic activities (e.g. Import/Export, shipping & disposition, supervision of study products packaging & labeling. Study set-up activities: identifying and performing feasibility, evaluation of potential sites & investigators, Performed and coordinated all activities required to submit and obtain MoH, Local Ethics Committee (IEC) and IND approval.Execution of clinical trials: defining scope, working within timelines & budget, tracking enrollment status and providing recruitment enhancement strategies as needed.Project Supervision: defining priorities, tracking action items to resolution, provide creative solutions when needed, training and management of project team, including freelance CRAs, CRCs and vendors, Performing periodic monitoring, accountability and termination visits.Performed scientific, clinical & regulatory summary data collection as part of establishing new clinical studies and as support to the company management

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 courses at the Belmonte Science Laboratories Center, including: Concepts in Biology and Chemistry (above 300 students) - Provided educational leadership by supporting

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