Jan Smith Email & Phone Number

Woerden, Ut, Nl

Haarlem, North Holland, Netherlands

On July 1st 2020 a new organizational structure was implemented for the Quality Analytical Laboratories. Personally the only change is in function title. No effect on job description and responsibilities as described below.

Name change of company: TEVA pharmachemie was changed into TEVA Nederland.Due to a reorganisation, the 2 analytical quality control departments were placed under 1 head. With the new name Quality Analytical laboratoriesBoth changes have no effect on function.As member of the Method Implementation team responsible for the analytical method transfer of technology transfer to enable future production of new complex sterile generics in the plant. Moreover, the team supports 24/5 the first non-commercial production batches for registration purposes and the first non-commercial stability program. As team member responsible for all occuring tasks from performing method assesments, writing method documents and transfer, verification and validation protocols, execution of the same protocols, and summarizing the studies in reports. Draft versions of protocols and reports are discussed with QA department,Trained as reviewer for data review including equipment perfomance verifications and Periodic reviews. Trained for multiple techniques and associated software like particle size (mastersizer & zetasizer), GC, UPLC, HPLC, UV-VIS, ELSD, CAD, empower 2 and 3.Trained on Trackwise to fully conduct the laboratory side process of global deviation reports (gDR), global Corrective and Preventive actions (gCAPA) and global changes (gCHANGE). recently 1 gCApa has been succesfully closed

Haarlem Area, Netherlands

Due to an internal restructuring, the quality innovative laboratory was divided under 2 supervisors with focus either on Compliance or Method Implementation. Became part of the "method implementation" group. As a result, support of compliance related studies was principally no longer part of my function.As member of the Method Implementation team responsible for the analytical method transfer of technology transfer to enable future production of new complex sterile generics in the plant. Moreover, the team supports 24/5 the first non-commercial production batches for registration purposes and the first non-commercial stability program. As team member responsible for all occuring tasks from performing method assesments, writing method documents and transfer, verification and validation protocols, execution of the same protocols, and summarizing the studies in reports. Draft versions of protocols and reports are discussed with QA department,Trained as reviewer for data review including equipment perfomance verifications and Periodic reviews. Trained for multiple techniques and associated software like particle size (mastersizer & zetasizer), GC, UPLC, HPLC, UV-VIS, ELSD, CAD, empower 2 and 3.Trained on Trackwise to fully conduct the laboratory side process of global deviation reports (gDR), global Corrective and Preventive actions (gCAPA) and global changes (gCHANGE). recently 2 gDRs have been succesfully closed

Haarlem

Started out on 6 months temporary contracts as payroller. Gained permanent TEVA contract per july 2017.As member of the analytical team support the analytical method transfer of the fasttrack project transfers (complex generics) to enable future production of new complex sterile generics in the plant.Moreover as member of the analytical team support for compliance and remediation projects. Responsible for performing method assesments, writing method documents and transfer, verification and validation protocols, execution of the same protocols, and summarizing the studies in reports. Moreover, the team supports 24/5 the first non-commercial production batches for registration purposes and the first non-commercial stability program. Various analytical techniques like GC, HPLC, and UPLC and topics like assay, related substances, residual solvents and cleaning validations are covered. Moreover, discussing opportunities, and executing the same, for late stage method optimization to increase future throughput in QC (continuous improvement) is an important part of the job. Following my permanent contract in 2017 trained as technique trainer and data reviewer. Over the years data review is expanded with equipment perfomance verifications and periodic reviews. Over the years the portfolio of trained techniques is gradually expanded with particle size (mastersizer & zetasizer), Mobius, ELSD, CAD, empower 3.

Amsterdam Zuid Oost

Translating customer questions in the area of solid state into a scientific proposals. Solid state research covers topics as process optimization, crystallization, polymorphism, salt formation, co-crystallization are covered.responsibilities: • Execution of the approved projects within the laboratory facilities. • Guarding project timelines and budget. • Data interpretation (i.e. thermal analyses, high throuput x-ray powder diffraction (HT-XRPD)) and reporting. • Customer communication throughout the entire project inclusive discussion of the final report.• Responsible for multiple laboratory technicians within my projects.Achievements:• Hands-on Implementation of Karl Fischer coulometric titration.• Hands-on introduction of amorphous drug resinate technology.• Setting-up an electronic library in Mendeley.

Nijmegen

Physchem Characterisation Platform. originator deformulation; excipient characterisation (i.e. lactose, mcc, hpmc); Black specks analyses and identification; International knowledge center; contact to CROs; Dynamic Vapour Sorption; Raman and terahertz Imaging; Scanning electron Microscopy; Particle size by Automated Microscopy; Karl fischer titration; GC; µXref; out of the box; knowledgable; strong research manager;

Nijmegen

GC-FID, Headspace, titration, method development, pre-validation, literature study, DVS, SEM

Nijmegen

Extracurricular activity

Nijmegen

Extracurricular activity

Nijmegen

Extracurricular activity

Nijmegen

GC-FID, Headspace, Dissolution (peak vessel; biowaiver), titration, method development, validation

Nijmegen

GC-FID, PTV injection, method development, validation

Bsc (Environmental Analysis), Halo (Higher Agricultural Laboratory Education)

Mlo, Analytical Chemistry