Mrinal De Email & Phone Number

Tada, Ap, In

ARD & AMV (Managerial Activities)•To lead a group of research executives, senior executives, assistant manager and deputy manager.•To take charge of day to day analytical method development and method validation activities.•To effectively monitor routine analysis and developmental stability studies.•To investigate thoroughly and provide scientific justifications to the regulatory related queries.•To observe, rectify and comply with cGMP, GLP, GDP and Data Integrity.•Co-ordination with the F&D/RA/TSD/ Plant QA-QC/overseas clients / sponsors, suppliers, vendors.•Keep track of project wise important milestone to ensure timely delivery and update to project management teamARD & AMV (Technical Activities)•To develop and validate robust and rugged analytical test methods to support formulation development, stability testing and quality control testing of new pharmaceutical formulations, ensuring delivery in accordance with project timelines. This includes Method Development and Method Validation (ID, Assay/BU/CU, RS and Dissolution).•To guide team to develop and validate new analytical methods for existing as well as for new products and troubleshooting at various stages to fast track the activities•To conduct and monitor analytical investigations to solve out complex analytical problems in support to formulation development activities.•To guide transferring new analytical techniques to the Quality Control (QC) laboratory.•To organize drug excipient compatibility studies and stability testing for new formulations.•To accommodate extended analytical support for process development to facilitate product development activities. • Interpretation of stability data of new R & D products to evaluate stability indicating capacity of analytical methods. •To carry out continuous literature survey for reasonable scope to re-develop existing analytical methods and re-validate the same with proven equivalency to effectively reduce the time and cost of productivity cycle

Pune, Maharashtra, India

A R & D (Managerial Activities)• To lead a group of research associates, sr. research associates, research scientists and managers.• To supervise the day to day analytical development activities.• Observing and complying with GMP, GLP, GDP and etc.• Establishing & implementing Analytical AQbD approach in analytical development.• Providing recommendations to the management on enhancing productivities & improving quality & compliance.• Ensuring proactive performance management of self & the team through regular performance discussions, annual performance reviews & career development.• Creating a culture which values trust and provides the opportunity for Employee development and growth in pursuit of demonstrating Collaboration, Courage, Perseverance and PassionA R & D (Technical Activities)• To develop and validate robust analytical test methods to support formulation development, regulatory, stability testing and quality control testing of new pharmaceutical formulations, ensuring delivery in accordance with project timescales and deadlines. It includes Method Validation, Assay AMV, RS AMV and Dissolution AMV.• To guide Scientist to develop and validate new analytical methods for existing as well as for new products and troubleshooting at various stages to fast track the activities• Solving complex analytical chemistry problems.• Transferring new analytical techniques to the Quality Control (QC) laboratory.• Validation of analytical Process/analytical Methods and Re validation in case of any change and up-gradation.A R & D (Documentation Activities)• Responsible of documentation of Finished Products Specification, STPs and IPS in R & D Lab.• Training & evaluation of the same to Employee for on job training on SOPs and Quality Management System, GLPs.• Reviewing/ Approving specifications and methods of analysis.• Reviewing/ Approving of Standard Operating Procedures (SOPs).

Bengaluru, Karnataka, India

SYNGENE, BBRC, ARD cGMP Testing (From Oct 2018 To Till Date)Technical Supervision & Review of followings: 1) Validation: GMP (IND/NDA)•Method validation for Identification, Assay, RS (IDD) & Purity/Impurities of Drug Substances (In process/Intermediates/API) by UPLC/HPLC.•Method validation for Identification, Assay & Purity/Impurities, CU & Dissolution of Drug product (SDD/Solid Oral Dosage) by UPLC/HPLC.•Method validation for Chiral purity, Enantiomeric impurities of Drug Substances (Intermediates/API) By HPLC/UPLC.•Method Validation for GTIs and Isotopes of Drug Substances (Intermediates/API) by UP/LC-MS (SQD).•Method Validation of Residual Solvents by GC/ GC-HS for Drug Substances (API).2) Core cGMP activities (IND/NDA): •Release Test for API & Formulation (Tox & Clinical), Specification setting, Reference Standard Qualification•Release Tests/Specification Setting Tests for Assay, RS (IDD), Purity/Impurities (RSQ), Chiral purity, GTIs content of Drug Substances (Tox & Clinical campaign) by UPLC/HPLC/LC-MS.•Release Tests/Specification Setting Tests for Residual Solvents of Drug Substances (Tox & Clinical Campaign) by GC/ GC-HS.•Release Tests for Assay, Purity/Impurities, CU and Dissolution of Drug product (Clinical & IND/NDA stability Campaign) By UPLC/HPLC.•Release Tests/Specification Setting Tests/RSQ for Identification (IR-ATR/IR-RAMAN) and Moisture Content (KF/KFC) by general methods.•Efficient investigations and implementations of CAPA for Laboratory Incidents, OOS/OOA/OOT and Deviations.3) Documentations: •Review of Validation Protocol/ Method Validation Report/In-house specification MOA/ COA.•Review of cGMP Raw Data/ LNBs/ ELNs/ Calibration/ IQ/OQ/PQ documents.•Review of SOP/IOP/STP/GAM through EDMS/Track wise.•Review and update of SOP in Document Control System and compliance of QMS.•Review and Recommended action for investigations of Laboratory Incidents, OOS/OOA/OOT and Deviations.

Bangalore

SYNGENE, BBRC, Analytical Research & Development (From Jan 2016 To Oct 2018)Held accountable for the followings: 1) Method Development•Method development for Identification, Assay, RS (IDD) of Drug Substances (In process/Intermediates/API) by UPLC/HPLC/LC-MS.•Method development for Assay, RS (IDD), CU & Dissolution of Drug product (Solid Oral Dosage) by UPLC/HPLC.•Designing and developing process parameters, testing techniques and changes design to improve the quality of the developmental tools which in turn effectively reduce the rate of rejection and re-work.•Effectively handling Deficiencies and Method Related Quires from regulatory and stake holders.2) Technical Support•Supporting and providing deep technical expertise to subordinates/team members for methods related challenges faced during development of related substances/Impurities/degradants/GTI, Assay/Potency, CU/BU, Dissolution methods by HPLC/UPLC/LC-MS.•Ensuring and guiding subordinates for optimizing appropriate conditions for Forced Degradation Studies related to Specific and Selective Analytical Methods.•Ensuring and guiding subordinates for Solubility Studies, Multimedia dissolution comparison/studies & selection of appropriate Discriminatory Media/Techniques.•Managing availability of laboratory resources to ensure the appropriate level of support and Prioritization for F&D/ Discovery activities and timely delivery of projects.3) Documentations: •Preparation & Review of Method Development Report / Development specification / MOA.

Goa

TEVA, Method Development (From Jun 2012 To Dec 2015)Held accountable for the followings: 1) Development •Method development of Assay / RS (IDD), UOC & Dissolution for new formulated product By UPLC/HPLC.•Method optimization of Assay / RS (IDD) for existing marketed product By UPLC/HPLC.•Forced Degradation studies to develop specific Assay method and selective RS (IDD) method. •Excipients compatibility studies. •Method Development for Dissolution of Drug product (Solid Oral dosages/IR//ER). •Solubility Studies, Multimedia Dissolution and Comparison studies.•Development of Discriminatory & Release Dissolution Media/Techniques.•Developmental support for optimization of formulation process.2) Validation•Method validation of Assay / RS (IDD), UOC & Dissolution for new formulated product By UPLC/HPLC.•Method validation for Dissolution of Drug product (Solid Oral dosages/IR//ER). •Process Validation and Cleaning Validation3) Documentation •Preparation of Method Development Reports, Method Validation Protocol, Method Validation Reports & Test Methods.•Review of analytical documents for dossiers as per US, EU & MHRA Registration Guidelines.4)Number of Projects Under taken & Successfully supported for Submission: 11

Zydus Cadila (Ptc) Cadila Health Care Ltd. Ahmedabad.

ZYDUS CADILA (PTC), Analytical Development Laboratory (From Oct 2010 To May 2012)Held accountable for the followings: 1) Development •Method Development for Assay, Related substances/Impurities/degradants (Forced Degradation & Mass balance), CU/BU of Drug product (Solids/Liquids/Suspensions).•Process Optimization and Hold time study.•Discriminatory Dissolution method development. •Cleaning Method Development.2) Routine•Routine Analysis for Formulation Department support.•Dissolution multimedia studies of Exhibit batch, Innovator & Comparison profile report preparation. •In Process and Stability analysis for new and reformulated products.•Routine lab activities & maintenance of testing/experimental records.•Characterization & Verification of API as per DMF.3) Documentation•Preparation of Method Development Reports and Test Methods.•Routine LNB.4) Project Under taken & Successfully supported for Submission • Eletriptan HBr, Ezetimibe, Olmesartan & Mefenamic Acid.

Aurangabad, Maharashtra, India

Method Development for Dissolution of Drug product (Solid Oral dosages/IR//ER).Multimedia Dissolution studies of Exhibit batch, Innovator & Comparison profile.Process validation and Hold time studyRoutine lab activities & maintenance of testing/experimental records.Method Validation for Assay, CU, Dissolution of Drug product.Method Validation for Dissolution of Drug product (Solid Oral dosages/IR//ER).

Master Of Technology - Mtech, Medicinal And Pharmaceutical Chemistry, 7.05

M.Sc, Biochemistry, 1St Class

Bachelor'S Degree, Microbiology, 1 St

B.Sc Micobiology