Satish Patel Email & Phone Number

Bordentown, Nj, Us

Palo Alto, California, Us

Worked as a Manager, Analytical Chemistry, R&D (freelance consultant) with BridgeBio pharmaceutical Inc. (BBIO), a Biotechnology Research company based in Palo Alto,CA on a remote capacity to work on the following activities and other activities as needed. Working to oversee 3rd party development of analytical methods, method validation, and investigations for out of specification, out of trend, and/or anomalous/atypical results. Provide technical review of various reports and raw data packages, utilizing a strong familiarity of small molecule analytical techniques, including the Review and critically assess data from ongoing GMP stability studies.Contribute to development and approval of specifications for raw materials, intermediates, and finished product with some knowledge of regulatory requirements in setting of specifications. Oversee and monitor the Development and Validation of analytical methods and verification of compendial methods using the lab instruments like HPLC, LC/MS, GC, GC/MS, USP dissolution testing apparatus, pH meters, UV/Vis spectroscopy, KF, and phase appropriate analytical method validation. Provide feedback and communicate results both internally and externally through oral and written updates and formal reports as necessary. Provide analytical support for API and Drug Product process development. Authoring development reports, protocols, methods, and filing documents such as NDA modules and agency inquiries.

San Francisco, Ca, Us

Working remotely for Pharmaceutical company in India on a protocol-based retrospective review of OOS/OOT investigations. Review of LIR/ CAPA/Deviation/ Investigation and writing report for gaps.

Westbury, Ny, Us

Worked on site as a consultant on Raw material Analytical Data Review for the client.

San Francisco, Ca, Us

Remotely, Worked for a pharmaceutical company in India for QA-QC R&D, Pharmaceutical consultant . Working on Data Integrity, batch records review, analytical lab data review, Method Validation/transfer, OOS and deviation, change control, CAPA

Westbury, Ny, Us

Worked remotely for a 503B Facility, for a cGMP manufacturer . Worked on batch records review, analytical review ,CAPA,OOS/OOT and Change Control Review.

Cambridge, Ma, Us

Worked as a (Remote From Home As A Freelance Consultant) QA/QC Consultant with Akebia Therapeutics, Inc. Responsible for the review of Drug Substance/Drug Products, Method validation/transfer protocols, reports, test methods, change controls , specifications review from the CDMO, CRO, and CMO like BioVectra, Patheon, Siegfried (St. Vulbas, France), Quotient Sciences, Catalent, SGS.

San Francisco, Ca, Us

Worked as a Data Integrity Consultant for "WOCKHARDT PHARMACEUTICAL in AURANGABAD,INDIA. Reviewed Analytical and QA data for ANDA, Drug Substance, Drug Products. ( Due to COVID-19 declared as global pandemic, this ended early)

Lake Forest, Il, Us

Data Integrity Reviewer QA/QC /R&D.

San Francisco, Ca, Us

Worked as a Pharmaceutical Consultant for IPCA LABORATORIES, INDORE, INDIA, for ANDA Data Reliability Assessment as requested by FDA on agreed protocol with a generics pharmaceutical company in INDIA. Responsible for performing review of Analytical Data Records, Analytical Method Validation, QA Batch Records, Data Integrity issues , checking any Stand Alone System is there and evaluating if data is reliable for the submission. Worked on review of past events which might have resulted as a compromised data could have been included in submission made to FDA, Auditing the data contained in submissions, and identification of root cause of findings, and CAPA to remediate submissions made to FDA to prevent recurrence. Also, reviewed the data which support expiry dating for Finished products, and root cause identification to remediate problems and prevent recurrence. Writing a report with listing the findings after completing the data review & related documents.

Tel-Aviv, Il

TEVA pharmaceuticals purchased generic business division of ALLERGAN and was moved to TEVA as a Product Stewardship & Technology Analytical Specialist with the Manufacturing Science & Technology group. Recently,LAID OFF due to job relocation.Worked on analytical issues for product optimization, technology transfer review and gap analysis for analytical test methods. Wrote SOP for analytical instruments. Worked on HPLC Method Development/Validation and Alternate API vendor qualification, troubleshooting & investigation.Hosted a telecon with the third party for the subject transfer and discussed all issues thoroughly to meet the tech transfer time line. Reviewed Extractable/Leachable Protocols, Reports and price quotations for the CMO, CRO &Third Party. Worked with RA for the CBE 30 and or PAS for the Analytical Test Method changes and proposed the Method Verification test plan for the CBE 30 submission, expertise as part of a CMC Analytical team and wider matrix teams.Reviewed existing analytical test method validations to ensure that the original method validations met current ICH requirements and were in compliance with the current USP.Addressed FDA 483 letter, Developed, Wrote Validation protocol and reports. Worked on Analytical Method transfer from one lab to another Lab, and reviewed methods and specification in collaboration with R&D Groups.Performed USP and in-house test method equivalency. Monitored, contacted USP for objection or justification and evaluated proposals in USP PF monographs. Executed USP and in- house method equivalency/validation study protocol, report, change control and updated specifications to comply with USP PF proposals. Evaluated API and excipient changes from API vendors on in-house analytical test methods and finished products. Solved laboratory investigations, identified unknown peak and remediated method issues. Audited lab data, peer review and tested QC samples. ( Lay off on April 12/2017 from TEVA)

Dublin, Coolock, Ie

Worked as Analytical Specialist in the Global Pharmaceutical Technology, and provided analytical support to the process, formulation and Reverse Engineering projects. Reviewed E/L & Injectable method validation protocols, reports with third party and contract lab price quotations.Worked on HPLC Method Development/Validation and Alternate API vendor qualification, Trouble shooting & investigation. Worked on Testing of Silicon Shells for Breast implants using Ion Chromatography.(December 2013 to Nov 2014 was ACTAVIS & On June 2015 officially became ALLERGAN)

Dublin, Ireland, Ie

Worked on a temporary assignment in the Stability department, recruited by the agency as a temporary staffing for a stability group.Tested Stability Samples using HPLC test methods.

Tel-Aviv, Il

Prior to TEVA acquisition this was known as Barr Laboratories and is laid off due to staff reduction. Worked on USP & in-house test method equivalency, monitored, contacted USP for objection or justification & evaluated the proposals in the USP PF monographs.Operation, trouble-shooting, and maintenance of HPLC, UPLC,PDA, Fluorescence , R.I Detector, IMS, GC, CE, UV, Ion Exchange, FT-IR, AA, Karl Fisher, TLC, titration and a variety of other analytical techniques used in CGMP/GLP environments. Calibration & IQ/OQ of a wide range of lab analytical equipment from pH meters and balances to HPLC system.Also worked on cross-functional teams with Analytical, Microbiology, Procurement, R&D, Supply Chain, Operations, Manufacturing. • Worked on Method Development, Method Validation, addressed FDA 483 comment letter, Method Evaluation, Method Remediation, Method Equivalency study, R&D Stability, In house Reference Standard qualification, & Method transfer.• Worked on method optimization of the existing test methods to meet the requirements.• Method Development & Validation includes Impurity/Degradation, Assay, Dissolution and Cleaning Validation Methods in line with the current Company SOP, USP & ICH Guidelines.Works with a vision of cost cutting & effectiveness.• Writing includes Method Validation Protocols, Reports, and Method Evaluation Reports of In House test methods in line with the current company SOP, USP, ICH guidelines.• Worked on Cleaning Validation method development & validation in line with the current industry standards by including different material of construction of the equipment.• Worked on CAPA’s,OOS investigation, wrote Deviation & Investigation Reports, Change Request Proposals using TrackWise & GM Pharma.• Performed test like C.U & Assay, Impurity, IR, Dissolution, Related Compounds & other test using HPLC, PDA, Fluorescence & R.I Detector, IMS, GC, CE, Ion Exchange UV, FT-IR, and KF etc.• Revise SOP’s & Training & coaching to the new staff.

Successfully performed Analytical Method Development, Method Validation, Addressed FDA 483 comment letter, Method Evaluation, Method Remediation, Method Equivalency study between USP & in- house test methods, R&D Stability, in- house Reference Standard qualification, and Method transfer. Also worked on cross-functional teams with Analytical, Microbiology, Procurement, R&D, Supply Chain, Operations, and Manufacturing.Effectively produced Cleaning Validation method development & method validation in line with the current industry standards and USP & ICH Guidelines by including different material of construction of the equipment.Wrote Method Validation Protocols, Reports, and Method Evaluation Reports of In House test methods in line with the current company SOP, USP, ICH guidelines.Worked on CAPA’s, wrote OOS Deviation & Investigation Reports, Change Control Request Proposals using TrackWise & GM Pharma. Tested C.U & Assay, Impurity, IR, Dissolution, Related Compounds & other test using HPLC, PDA, Fluorescence & R.I Detector, IMS, GC, CE, Ion Exchange UV, FT-IR, and KF etc. Revised SOP’s and reviewed/updated specifications. Trained and coached new staff.

Worked in this generic pharmaceutical company on performing quality control analysis for production runs. Worked on Dissolution C.U & Assay, IR, Related Compounds & other test using HPLC, UV, IR, KF etc. Worked on technology transfer, Raw Materials, Finished Product & Stability testing.

Chestnut Ridge, Ny, Us

Worked for the quality control laboratory testing of the company’s line of generic drugs. Primarily perform Content Uniformity, Assay & Dissolution, Impurity, KF, IR analyses on Finished Products, Stability & Raw Material samples using appropriate laboratory equipment like HPLC,GC,UV,FT IR,KF according to GMP and USP accepted procedures.

Prior to the general staff reduction by this manufacturer of generic pharmaceuticals and aerosol products, worked on the Quality control testing for the full range of company products. Performed analytical tests in accordance with cGMP and GLP practices on solid dosage and aerosol-propelled forms of generic drugs. Designed and implemented the quality control testing protocols for a new aerosol propelled product, with full responsibility for in-process product testing

Responsibilities included performing quality control analyses on company’s line of generic drugs. Analyses were performed on Finished Product, Stability & raw materials. Performed test like Dissolution, CU & Assay, IR, KF using HPLC, GC, UV, FT IR, KF and worked with method validation & other R & D assignments.

Bachelor'S Degree, Chemistry

Education record