Dr Ketankumar Patel Email & Phone Number

Maidenhead, Gb

Maidenhead, England, United Kingdom

Working as a ADL-QC & Development manager for Oral solid dosage products at Noumed Life Sciences to develop bespoke generic medicinal products for variety of therapeutic applications in cGLP, cGMP, MHRA & TGA approved product facility. The responsibilities include to manage ADL-QC , F&D team & support to file new MAs, site transfers, variations, troubleshooting PVs for the current and new MA licenses in terms of product quality, safety and stability. The role also supports responsibilities towards formulation development, product development, process validation, method development/validation/characterisation/stability studies, Data Analysis, QA & QMS management, audits, Change control management, Vendor Qualifications, setting up the Specs, OOS/Deviations Investigations, CAPA implementations.

Paington, Devon, Uk

Worked as a Stability specialist for Stability Analytical Chemistry section in cGLP, cGMP, MHRA accredited sterile, liquid injectables, oral liquid production site. Responsible for managing Stability Team & multiple studies to the required standards in compliance with regulations. The role supports to file new MAs, variations to the current MA, MS and IMP licenses in terms of product quality, safety, stability. This role supported responsibilities towards formulation development, product development, process validation, method development/validation/characterisation/stability studies, Data Analysis, OOS/Deviations investigations, change controls, CAPA implementations, vendor qualifications, specification reviews, product quality reviews & managing QA activities and managing QMS systems.

Gujarat, India & Usa

Worked as a Senior Consultant for Analytical/Bio Chemistry section. Responsible for all the activities going on in Analytical Laboratory on the client sites. Includes method development/validation/characterisation/stability studies & Data Analysis.

Hitchin, Hertfordshire, England, United Kingdom

Worked in an cGLP, cGMP and MHRA accredited laboratory contributing towards development of new Herbal drug formulations and anticancer precursor molecules.Synthesis & Analytical Techniques  Development and Validation of Synthesis & Analytical methods for variety of Herbal drug products formulations and anticancer precursor molecules followed by their validation as per ICH guidelines for acquiring regulatory licenses & ASFM submissions. QMS systems management. Stability studies, LC, Ion Chromatography, IC, GC, GC- Headspace.Key Duties & Accomplishments To plan, design & allocate projects & resources (QBD and DOE) ensuring that assigned projects meets timeline in a cost-effective manner to required quality.  Actively mentor, manage and train fellow team members. To research new methodologies for new products formulations and scale up technology. To Lead Formulation development activities & scale up for New drug products. Data interpretation, statistical data analysis & data presentation to support setting up of specifications & Product shelf-lives, determining testing schedules. QA/QMS management for Deviations/OOS/OOT/OOT/CAPA/Change controls/RAs/VQ/PQR. Batch release activities & COAs generation for the product batches.

Stevenage, Hertfordshire, Uk

Worked in an cGLP, cGMP, and MHRA accredited laboratory contributing towards development of new drug molecules & drug products.Analytical Techniques. Development & Validation of Analytical methods for variety of drug substances/imps/formulations following by their validation as per ICH guidelines for acquiring Reg Licenses. Stability studies, LC.LC-MS, IC, ICP, GC/GC-MS, HS, XRF, Bio/Immuno Assays, ELISA, Gel electrophoresis, Western blot, Flow cytometry, ELISSPOT.Key Duties & Accomplishments To plan, design and allocate projects and resources (QBD) ensuring that assigned projects are performed in an effective and efficient manner in terms required time frames & quality as per the set protocols.  Actively mentor, manage & train 14 fellow team members to follow right for first time approach with safe, effective & efficient science to adhere quality compliance as per regulatory requirements maintaining necessary training profiles. To research new methods for new products, contribute towards method protocols to support development in analytical testing of APIs and drug product stability programmes. Data interpretation, statistical data analysis, data presentation to support setting up of specifications, Product shelf-lives, testing schedules and justification of specifications. Provide technical & operational leadership on assigned, complex projects. To carry out development work assignment on different projects and take responsibility to establish EHS, REACH, and other safety aspects. To compile detailed analytical reports for CMC, regulatory submissions for MHRA, EP. To review the report & to sign off the data for audit purposes ensuring that the reports are written to the required quality standards. Day to day management of work, resources, work progress, rotas & being responsible for any technical troubleshooting. Provide technical leadership for assigned projects.

Reading, England, United Kingdom

Worked in an cGLP, cGMP and MHRA accredited laboratory contributing towards development of contract testing of wide variety of APIs & pharmaceutical formations.Analytical Techniques  Development and Validation of Analytical methods for variety formulations following by their validation as per ICH guidelines for acquiring regulatory licenses. Stability studies, Sterile Products Testing. GC, GC-MS, GC- HeadspaceKey Duties & Accomplishments To plan, design and allocate the projects and resources ensuring that assigned projects meets timelines.  To review the report and to sign off the reports for audit purposes ensuring that the reports are written to the required quality standards. Day to day management of work, resources, work progress, rotas and being responsible for any technical troubleshooting. Provide technical expertise on assigned projects. Management of OOS/OOE/OOT/Deviations/CAPA/Change controls To research new methodologies for new products and write method protocols to support improvements in analytical testing.

Edgware, London, Uk

Products: Sterile/Non sterile formations, Tablets, Capsules, Ointments, Suspensions, injections, solutions, Inhalation solutions/pressurized inhalers, vitamins injections, Sterile solutions & liquid dosages, drug impurities, antibiotics & herbals.Analytical Techniques: Development & Validation of Analytical methods, validation as per ICH guidelines, Stability studies, Sterile Products Testing. HPLC with VWD, RI, DAD, FLD, ELSD, GC, GC-Headspace, IC, MS, UV/Vis spectroscopy, IR, Dissolution, Densitometry, Potentionmetric/ KF titrations, wet chemistry, Microbiology. Key Duties & Accomplishments:To plan, design and allocate the projects and resources (QBD) ensuring that assigned projects are performed in an effective and efficient manner in terms of budget, required time frames and quality as per the set protocols. To review and sign off the reports, SOPs, Protocols, regulatory applications, Specifications, COAs, and safety assessments.Development of QMS systems, management of OOS/OOT/OOE/Deviations/CAPAs/Change controls/trainings.Batch release of about 150 batches of finished product formulation and COAs generation for QP release. To review the data and propose the impurity limits, shelf life, specifications and provide any justifications for regulatory bodies for licensed products.To review and sign off regulatory submissions for authorisations required from different regulatory agencies. Day to day management of 15 fellow colleagues in terms of work allocation, resources allocation, work progress, rotas and being responsible for any technical troubleshooting.Actively mentor & train fellow team members to follow right for first time approach with safe, effective and efficient science to adhere quality compliance as per regulatory authority requirements/customer expectations maintaining necessary training profiles providing technical leadership. Performing internal/external Audits and Quality Assurance in terms of overall system performances.

Teddingtion, London, Uk

Worked in an UKAS, cGLP, cGMP, ISO17025 accredited lab to procure, synthesize & certify all British Pharmacopoeial reference standards, Sterile/Non Sterile Solid/liquid formulations, injectables, suspensions, emulsions, lozenges, patches, inhalers, APIs, drug impurities, impurity standards, antibiotics and herbals.Analytical: Developed Analytical methods for new & existing British Pharmacopoeia monographs for APIs, Herbal/Homeopathic formulations following by their validation as per ICH guidelines. Extractable/Leachable, stability studies. HPLC analysis using UV, RI, Diode Array and florescent detectors. GC-MS/MS, GC-MS Headspace, LC-MS/MS, KF, wet chem, Bio/Immuno Assays, ELISA, Gel electophorois, WB, Flow cytometry, ELISSPOT.Key Duties & Accomplishments: Participated in the European Directorate for the Quality of Medicines & HealthCare (EDQM), Official Medicines Control Laboratories (OMCLs) proficiency testing studies.Drafted and published British Pharmacopoeia monographs each year from 2007 to 2013 in BP publication. Responsible for procurement, testing and certification and release of Reference Standards.To be responsible for analytical method development and validation work for monograph development. Drafting and representing the proposals for impurity limits and specifications, justifications, COAs, methods, monographs, SOPs, risk/safety assessments for EAG committees for their comments and approvals for incorporations. Presented the monograph development work at different EAG committees at British Pharmacopeia/MHRA meetings. Liaised within the MHRA and other Laboratories within EU for implementation of new regulatory legislations. Review and updating SOPs. Routine maintenance, periodic calibrations. To be responsible for British Pharmacopoeia Chemical Reference Standards stability program. Synthesize drug impurities and impurity standards, generate batch specific data. To assist license holders for the queries for any monographs/formulations.

Doctor Of Philosophy - Phd, Chemistry

Activities and Societies: Title “Synthesis, Characterization and Application of Novel Polyurethanes based on ε-Polycaprolactones”. .

Master'S Degree, Synthetic Organic Medicinal Chemistry, First Class

Bachelor'S Degree, Chemisty With Vocational Industrial Chemistry, First Class