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1.
Job Categories : Sciences/Lab/R-D
Job Sub Categories : Sciences/Lab/R-D other
Job Position : Analytical Chemist (pharmaceutical products)
2.
Job Categories : Technician
Job Sub Categories : Technicians
Job Position : RD Chemist (HLPC, GC, Method Validation)))
3.
Job Categories : Manufacturing/QA-QC
Job Sub Categories : General/Production
Job Position : QA supervisor
Job Location : Bangkok (All)
Job Type : Full time
Availability : Immediate
Working Bangkok : Yes
Graduation year : 2007
Certificate : Master's Degree
Faculty : Molecular Biology
Major : Medical Science
GPA : 3.06
Graduation year : 2002
Certificate : Bachelor's Degree
Faculty : Biology
Major : General Science
GPA : 2.57
Last Position : New product analytical chemist
Period : October 2024 to October 2025
Job Description :
1. To develop the analytical method of generic drug from published paper database the preanalytical with all analytical method that covering assay, dissolution, impurity test.
2. Responsible analyze to quality control of pharmaceutical products in trial batch (pre-process manufacturing).
3. Responsible following to a stability study of pharmaceutical products corresponding to the ASEAN guideline.
4. Improvement of analytical methods based on ICH guideline and transfer method to routine laboratory.
Development method of generic drug (In house method)
- New analytical method of organic impurity Diphenidol Hydrochloride (In house method) and organic impurity Cephadol 25mg film-coated tablets (In house method)
Development and Method Validation with HPLC and Potentiometric titration
- Development analytical of Diphenidol Hydrochloride assay with potentiometric titration method (development from JP18 pharmacopeia)
- Development analytical of Diphenidol Hydrochloride impurity with Gradient method of HPLC (development from JP18 pharmacopeia)
- Development analytical of Cephadol 25mg assay with Isocratic method of HPLC (development from JP18 pharmacopeia)
- Development analytical of Cephadol 25mg impurity with Gradient method of HPLC (development from JP18 pharmacopeia)
- Development analytical of Relative retention factor (RRF) of Diphenidol HCl and Cephadol 25mg tablets for impurity factor to truly %w/w of qualitative product and transfers to routine analysis.
Example manufacturing optimization (pre-formulation) of pharmaceutical product
- Cephadol 25mg core tablets (Diphenidol HCl-Active ingredient)
- Neutapin 25, 100, 200mg core tablets (Quetiapine Fumarate-Active ingredient)
Update and improvement of instrument work instruction (WI)
- Writing work instruction of 12-vessel dissolution tester (Hanson, USA) CD14 model.
- Writing work instruction of Performance verification test (PVT) for dissolution tester and development method with accordance with United States Pharmacopoeia (USP) performance.
Writing Validation protocol of New product development
- Validation protocol of impurity I of Diphenidol Hydrochloride Raw material (development from JP18 pharmacopeia)
- Validation protocol of assay of Diphenidol Hydrochloride Raw material (development from JP18 pharmacopeia)
- Validation protocol of impurity I of Cephadol 25mg tablets (development from JP18 pharmacopeia)
- Validation protocol of assay of Cephadol 25mg tablets (development from JP18 pharmacopeia)
- Validation protocol of dissolution of Cephadol 25mg tablets (development from JP18 pharmacopeia)
Last Position : Analytical chemistry
Period : May 2021 to November 2023
Job Description :
Development method of new drug (In house method without another official monograph)
- New analytical method of Lercanidipine 20mg tablets (In house method) Including assay, dissolution, Impurity and dissolution profiles.
- New analytical method of Dapagliflozin 10mg tablets (In house method) Including assay, dissolution, Impurity and dissolution profiles.
Update and improvement of instrument work instruction (WI)
- Writing work instruction of 12-vessel dissolution tester - PTWS1420 model (PHARMA TEST, Germany)
- Writing work instruction of 6-vessel dissolution tester PTWS820D model (PHARMA TEST, Germany)
- Writing work instruction of deionized and ultrapure type purification system - Cascada,
Duo-i-III.I model (Avidity Science, England)
1. To develop the analytical method of new drug (Finished product) from basic science and published paper database on internet to the new all analytical method that covering assay, dissolution, impurity test and dissolution profiles.
2.The compare with the similarities (F2) and the difference (F1) under dissolution profiles requirements that terms the Biowaiver to objective the improvement of drug formulation.
3.The compare dissolution profiles with Nonlinear Optimization Algorithm (Bootstrap f2 method, Multivariate confidence region etc.) for requirements that terms the Biowaiver to objective the improvement of drug formulation
4.To improvement of drug solubility for design dissolution profiles test with based on USP, BP or EP pharmacopeia and the ASEAN guideline and to comply with the equipment Laboratory instruments and this is correct according to laboratory standard.
5.Responsible analyze to quality control of pharmaceutical products in trial batch (pre-process manufacturing).
6.Responsible following to a stability study of pharmaceutical products corresponding to the ASEAN guideline.
7.Improvement of analytical methods based on ICH guideline and transfer method to routine laboratory.
Example manufacturing optimization (pre-formulation) of pharmaceutical product
- Atorvastatin 10, 20, 40 and 80mg tablets
- Celecoxib 200 and 400mg capsules
- Sitagliptin 50, 100mg tablets
- Sildenafil 20, 50, 100mg tablets
- Rivaroxaban 15, 20mg tablets
- Etc.
Example improvement dissolution profiles of pharmaceutical product
- Atorvastatin 10, 20, 40 and 80mg tablets
- Celecoxib 200 and 400mg capsules
- Sitagliptin 50, 100mg tablets
- Sildenafil 20, 50, 100mg tablets
- Rivaroxaban 10, 20mg tablets
- Dapagliflozin 10mg tablets
- Lercanidipine 10mg tablets
- Ezetimibe 10mg tablets
- Montelukast 10mg tablets
- Etc.
Example a stability study of pharmaceutical products
- Atorvastatin 10, 20, 40 and 80mg tablets
- Celecoxib 200mg capsules
- Sitagliptin 50, 100mg tablets
- Sildenafil 50, 100mg tablets
- Rivaroxaban 10, 20mg tablets
- Omeprazole 20mg capsules
- Etc
Last Position : RD Research and Development and MV Method Validation supervisor
Period : April 2018 to February 2021
Job Description :
A. RD Research and Development Responsibilities
1. To develop the analytical method of new company product that co-project with GENSIGN company, Especially the hormone drug group Levonorgestrel and Finasteride project
2. The compare with the similarities F2 and the difference F1 under dissolution profiles requirements that terms the Biowaiver to objective the improvement of drug formulation.
3. To develop the chemical analytical methods based on USP, BP or EP pharmacopeia and the ASEAN guideline and to comply with the equipment Laboratory instruments and this is correct according to laboratory standard.
4. Improvement of chemical analytical methods based on ICH guideline and transfer method to routine laboratory.
B. MV Method Validation Responsibilities
1. Design and writing for validation of analytical method protocolreport in according to a current ICH guideline and for new dosage form that published in current USP pharmacopoeia.
2. To improvement the correctness of the method validation with refer to drug product formulation.
3. To update method validation to be the presently pharmacopoeia and transfer method to routine laboratory.
4. Prepare drug registration documents up to presently date Dedicated the chemical analytical document
5. To transfer knowledge of method validation to the team and proposed that everyone has an equal basis for knowledge and able to build on knowledge according to the ability of each individual.
6. To training within the team that by selecting a topic that still lacks knowledge, in order to have an opportunity to exchange knowledge and experience within the team.
Example validation verification protocol and reports Assay topics HPLC
- Verification protocolreport for assay of Amoxicillin trihydrate RM and Amoxicillin 500MG capsules FP
- Verification protocol report for assay of Clavulanate Potassium RM
- Verification protocol report for assay of Amoxicillin 875mg and Clavulanate Potassium 125mg film-coated tablet FP
- Validation protocol report for assay of Ibuprofen RM and Ibuprofen 600mg film-coated tablet FP
- Verification protocol report for assay of Ciprofloxacin RM and Ciprofloxacin 250mg, 500mg tablets
- Verification protocol report for assay of Clonazepam RM and Clonazepam 0.5mg tablets FP
- Verification protocolreport for assay of Cephalexin RM and Cephalexin 500mg capsules FP
- Verification protocol report for assay of Ketoconazole 2vv cream
- Verification protocol report for assay of Levonorgestrel RM and Levonorgestrel 0.75mg tablets FP Co project with GENSIGN
- Etc.
Dissolution topics HPLC and spectrophotometer
- Validation protocol report for dissolution of Ibuprofen 600mg film-coated tablet
- Validation protocol report for dissolution of Amoxicillin 500mg capsules
- Etc.
Related compound Impurities topics HPLC
- Verification protocol report for impurity of Ciprofloxacin RM
- Verification protocol report for Related compound C of Ibuprofen RM and Ibuprofen 600mg film-coated tablet
- Verification protocolreport for impurity of Clonazepam RM and Clonazepam 0.5mg tablets FP
- Verification protocol report for impurity of Cephalexin RM
- Verification protocol report for impurity of Levonorgestrel RM and Levonorgestrel 0.75mg tablets FP Co project with GENSIGN
- Verification protocol report for impurity of Amoxicillin trihydrate RM
- Verification protocol report for impurity of Clavulanate Potassium RM
- Verification protocol report for impurity of Alprazolam RM
- Verification protocol report for impurity of Clavulanate Potassium RM
- Verification protocol report for impurity of Lorazepam RM Lorazepam 0.5mg and 2mg film-coated tablets
- Etc.
Development and Method Validation with GC
- Verification protocol report for aliphatic amine of impurity of Clavulanate Potassium RM
- Development analytical of Alcohol content methanol and ethanol in liquid spray and gel hand sanitizer with GC.
- Development analytical method of Volatile solvent residual impurity in bromhexine syrup with GC.
Last Position : Analytical Chemist
Period : October 2009 to July 2014
Job Description :
1. Develop analytical methods for the quality control of active ingredients and pharmaceutical products in trial batch pre-process manufacturing.
2. Design and writing for validation of analytical method protocol report in according to a current ICH guideline and for new dosage form that published in current USP pharmacopoeia.
3. Responsible analyze to quality control of pharmaceutical product in manufacturing pilot Lab scale and production scale.
4. Responsible following to a stability study of pharmaceutical products corresponding to the ASEAN guideline.
Achievement
1. To success document preparation of validation verification protocol report are adjusting for a suitable a present laboratory and advanced drug delivery system.
2. To success accuracy, precision, repeatability linearity and robustness test of qualitative drug under validation method.
3. To success quality control in manufacturing pilot Lab scale and production scale of pharmaceutical product.
Example manufacturing pilot of pharmaceutical product
- Omeprazole 20mg capsule
- Pantoprazole 20 and 40mg capsules
- Metformin 500 and 850mg tablets
- Levetiracetam 250, 500mg tablets
- Warfarin 2 and 3 mg tablets
- Valsartan 80, 160 and 320 mg tablets
Sildenafil 20 and 100 mg tablets
- Etc.
Example validation verification protocol reposts
- Verification protocol and report for assay and related compound D of Ondansetron injection
- Verification protocol and report for assay, dissolution and impurity of Metformin HCl tablets
- Validation protocol report for assay, dissolution and impurity of Levocetirizine dihydrochloride film-coated tablet
- Validation protocol report for assay, dissolution and impurity of Itraconazole capsules - Etc.
Institute :
- Para scientific,CO,.LTDPeriod :
- August 2020 to August 2020Course :
- Training of basic GC knowledge and a maintenance of GC instrumentInstitute :
- Synchrotron Light Research Institute, Nakhon Ratchasima, ThailandPeriod :
- April 2017 to April 2017Course :
- Protein structural analysis by SAXs (X-ray Scattering Angle) techniqueInstitute :
- Archemica companyPeriod :
- April 2011 to April 2011Course :
- Training of basic HPLC knowledge and a maintenance of HPLC instrumentInstitute :
- Molecular Biology Training, Chromosome Laboratory Center CO., LTD., ThailandPeriod :
- April 2001 to May 2001Course :
- Cell (Human Blood) culture and diagnosis of chromosome disorder using G-banding technique.
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| Languages | Speaking | Listening | Reading | Writing |
|---|---|---|---|---|
| English | Medium | Medium | Excellent | Excellent |
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- 1.Assoc.Prof.Dr.Vipavee Anupunpisit 2.Dr.Nantakan Suwanpidokkul (GPO)
1.Professor/Instructor, Senior Advisor Anatomy Department, SWU 026641000#4501 (Telephone), 0875937222 (Mobile)
2.Deputy Managing director of Research and Development Institute, GPO, 022038051 and 022038052 (Telephone)
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