Jan Smith

Jan Smith Email and Phone Number

Analyst II - Method Implementation - Quality Analytical Laboratories at Teva Nederland at Teva Nederland @ Teva Nederland
Professor Eykmanweg 8, Waalwijk,Noord Brabant 5144 ND,Netherlands
Jan Smith's Location
Woerden, Utrecht, Netherlands, Netherlands
Jan Smith's Contact Details

Jan Smith personal email

About Jan Smith

Sound scientific skills combined with intimate knowledge, and strong communicative competence enable translation of customer needs into successful practical analytical solutions in-company or external.Currently involved as research analyst in the analytical method transfer of complex generic technology transfer. Moreover, as part of the team support 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 inreports. Draft versions of protocols and reports are discussed with QA department,

Jan Smith's Current Company Details
Teva Nederland

Teva Nederland

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Analyst II - Method Implementation - Quality Analytical Laboratories at Teva Nederland at Teva Nederland
Professor Eykmanweg 8, Waalwijk,Noord Brabant 5144 ND,Netherlands
Website:
recupair.nl/teva
Jan Smith Work Experience Details
  • Teva Nederland
    Analyst Ii - Method Implementation - Quality Analytical Laboratories At Teva Nederland
    Teva Nederland Jul 2020 - Present
    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.
  • Teva Nederland
    Research Analyst - Method Implementation - Quality Analytical Laboratories
    Teva Nederland Dec 2019 - Jul 2020
    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
  • Teva Pharmachemie
    Research Analyst - Method Implementation - Quality Innovative Laboratory
    Teva Pharmachemie Mar 2019 - Dec 2019
    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
  • Teva Pharmachemie
    Research Analyst - Quality Innovative Laboratory
    Teva Pharmachemie May 2015 - Mar 2019
    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.
  • Crystallics
    Project Leader Solid State
    Crystallics Jun 2014 - Nov 2014
    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.
  • Synthon
    Specialist Physchem Characterisation Platform Analytical Research Group
    Synthon Jan 2010 - May 2014
    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;
  • Synthon
    Researcher Analytical Research Group
    Synthon Jan 2002 - Dec 2009
    Nijmegen
    GC-FID, Headspace, titration, method development, pre-validation, literature study, DVS, SEM
  • Synthon
    Member Ondernemingsraad
    Synthon Jun 2007 - Aug 2008
    Nijmegen
    Extracurricular activity
  • Synthon
    Member Ondernemingsraad And Vgwm Commissie
    Synthon Aug 2002 - Aug 2005
    Nijmegen
    Extracurricular activity
  • Synthon
    Bhv (Bedrijfshulpverlener)
    Synthon Jun 1997 - Aug 2003
    Nijmegen
    Extracurricular activity
  • Synthon
    Research Analist Analytical Research & Development
    Synthon Jun 1997 - Dec 2001
    Nijmegen
    GC-FID, Headspace, Dissolution (peak vessel; biowaiver), titration, method development, validation
  • Synthon
    Trainee Analytical R&D
    Synthon Aug 1996 - Jun 1997
    Nijmegen
    GC-FID, PTV injection, method development, validation

Jan Smith Skills

Analytical Chemistry Gas Chromatography Chromatography Hplc Data Integrity Method Development Validation Lean Six Sigma Characterization Uplc R&d Water Content Uv/vis Scanning Electron Microscopy Particle Size Analysis Analytical Skills Karl Fischer Pharmaceutical Industry Dissolution Excipients Spectroscopy Uv Dvs Reference Manager Ir Tga Solubility Mass Spectrometry Generic Drugs Chemistry Gmp Uv Vis Pharmaceuticals Troubleshooting Analysis Public Speaking Academic English Black Specks Knowledge Sharing Gc Gc/ms Programming Microsoft Office Empower Life Sciences

Jan Smith Education Details

Frequently Asked Questions about Jan Smith

What company does Jan Smith work for?

Jan Smith works for Teva Nederland

What is Jan Smith's role at the current company?

Jan Smith's current role is Analyst II - Method Implementation - Quality Analytical Laboratories at Teva Nederland at Teva Nederland.

What is Jan Smith's email address?

Jan Smith's email address is in****@****ail.com

What schools did Jan Smith attend?

Jan Smith attended Hogeschool Van Hall Larenstein Velp, Mbo College Eemvoorde Amersfoort.

What are some of Jan Smith's interests?

Jan Smith has interest in Children, Economic Empowerment, Education, Environment, Poverty Alleviation, Science And Technology, Disaster And Humanitarian Relief, Human Rights, Arts And Culture.

What skills is Jan Smith known for?

Jan Smith has skills like Analytical Chemistry, Gas Chromatography, Chromatography, Hplc, Data Integrity, Method Development, Validation, Lean Six Sigma, Characterization, Uplc, R&d, Water Content.

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