VENUGOPAL VALLABHU

Upper Dublin, PA ***** C: 732-***-**** ad2y6c@r.postjobfree.com

Summary

Detail oriented, highly motivated pharmaceutical QC/Analytical/QA professional with experience in analytical method development, method validation, method transfers, method verifications, technical review, instrument qualifications, lab informatics implantation, qualification and quality control release, stability testing for pharmaceutical materials, small molecule drug substances, drug products, cell culture media & peptides.

Skills

Proficient in analytical techniques such as Chromatography techniques UHPLC, HPLC, GC, TLC, Spectroscopy techniques UV-Vis, FT-IR, Dissolution, LC-MS (SQD), ICP-OES, KF, DSC Viscometer, Rheometer, Artel PCS and wet chemistry

Industries: Bulk Chemicals, Generics, and Branded

Small molecules: NCEs, INDs, ANDAs & NDAs

Biologics: Peptides, Cell Culture Media

Dosage forms: Oral solid dosage forms (IR, DR, ER), Oral liquids, Sterile liquid and lyophilized dosage forms

Instruments: Waters Acquity UPLC, H-class, Alliance, UV, DAD, RI, Fluorescence detectors, Shimadzu, Perkin-Elmer, Agilent LC & GC with Headspace Sampler

CGMPs, ICH Guidelines, QbD, Lean processes and Compendium Requirements

Software: Symyx ELN, Labware GLIMS, Empower, Chromeleon, EZChrom, TotalChrom, Openlab Chemstation, Trackwise, Spectrum, Compliance Wire, Brookfield RheocalcT, Master Control, Artel PCS Software and Documentum

Support Product development, Project planning, Author & Review Protocols, Troubleshoot instruments, investigations, Training

OOS, OOT, COAs, Specifications, Investigations, Laboratory incidents/Lab events, CAPAs, Deviations, Spreadsheet validations

Experience

Technical Reviewer (Consultant) 02/2023-08/2023

Strides Pharma Ltd Bangalore, India (Hybrid)

Retrospective review of chromatography data for extraneous peaks, atypical chromatography, proper integration, missing integration, correct identification for peaks, audit trails, formulae, calculations, results and compliance.

Data integrity check for chromatography data in Chromeleon software

Review analytical raw data sheets, results in Labware LIMS, transcription of data from LIMS to Chromeleon.

Identify discrepancies in method validation reports and test methods.

Technical Reviewer (Consultant) 04/2022-07/2022

Catalent Pharma Solutions RTP, NC

Retrospective review of chromatography data for extraneous peaks

Verified data in stability COAs, stability trend summary reports for accuracy, compliance, transcription errors against lab books, specs, methods

Reviewed stability raw data against methods and specs for compliance

Reviewed spread sheet validation data against protocol, sops for data accuracy, errors, and compliance

Reviewed method validation data calculations, spreadsheets for accuracy

Prepared stability CFAs, stability summary reports with data from source data in lab books

QC Chemist (Consultant) 05/2021-02/2022

Fresenius-Kabi USA Inc Buffalo, NY

Participated in investigation of manufacturing process/analytical methods for low assay of Peptide sterile IV drug product.

Continued

Supported laboratory investigations and lab events/incidents. Assisted in OOT, OOS results investigation.

Re-developed and re-validated UPLC Assay method.

Authored supplemental validation report and revised analytical method.

Retested, closed OOS batch analysis and cleared path forward for PPQ batch manufacturing.

Analyzed in-process samples, release and stability samples for PPQ batches.

System Analyst (Consultant) 08/2020-11/2020

Spark Therapeutics (Remote Position) Philadelphia, PA

Supported Waters Empower Software implementation project in QC lab as business superuser. Reviewed validation plan, user requirements specification, risk assessment, configuration specification documents. Assisted in implementation project planning activities and collaborated with Waters, IT, CSV teams.

QC Chemist (Consultant) 09/2018 to 09/2019

AMRI Albany, NY

Analyzed raw materials, intermediates, in-process, reaction monitoring and APIs release & stability samples. Used Open lab CDS to control, acquire, process and report data from Agilent LCs and GCs. Peer reviewed data in Open lab CDS. Executed one method validation protocol. Assisted and trained junior chemists. Successfully supported key high volume drug substance manufacturing campaign project which resulted in higher customer satisfaction with respect to timelines, quality and productivity. Supported laboratory investigations and lab events/incidents. Assisted OOT, OOS results investigation. Assisted in implementation of CAPAs.

Sr. Scientist (Consultant) 09/2017 to 05/2018

Janssen Pharmaceuticals, Johnson & Johnson Malvern, PA

As a technical reviewer in large molecule material science group reviewed analytical methods, analytical validation/qualification protocols, data & reports for cell culture media materials, CAR T-cell product and adjuvant. Compare methods, data evaluation, input suggestions on method development at CROs. Troubleshoot and remediate dissolution method for transdermal patch small molecule drug product using apparatus-7.

Principal Scientist 01/2017 to 08/2017

Vertice Pharma Inc Bridgewater, NJ

Analytical team member of product development projects (ANDAs), authored and reviewed analytical documents, assisted in trouble shooting analytical issues, set up new labs with old & new instruments, qualified various analytical instruments, authored and reviewed SOPs. Trained junior scientists, set up service agreements for laboratory services with external vendors.

Sr. Scientist (Consultant) 01/2016 to 04/2016

Sancilio & Company Inc West Palm Beach, FL

Prepared gap method validation report and tested stability samples for dissolution of soft gelatin capsules using Apparatus-III.

Sr. Scientist (Consultant) 05/2015 to 09/2015

McNeil Consumer Healthcare, Johnson & Johnson Fort Washington, PA

Executed two UPLC method validations for a multi component oral liquid drug product. Designed validation experiments and drafted validation reports.

Chemist (Consultant) 03/2014 to 12/2014

Impax Laboratories, Inc Hayward, CA

Executed about 15 gap validation protocols and met aggressive timelines in advance. Trained and assisted junior chemists in troubleshooting and investigations.

Scientist (Contract) 12/2011 to 12/2013

Janssen Pharmaceuticals, Johnson & Johnson Titusville, NJ

Developed Assay, Impurities/degradation products, Content Uniformity UPLC methods for marketed product (Fixed dose, IR). Single UPLC method replaces RP-HPLC assay method and NP-HPLC Impurities/degradation products method. Continued

Evaluated USP compendia methods verification, specifications for drug substance and authored technical reports, test methods for ETS change control to adopt. Coordinated method transfer from manufacturing site to CRO laboratory. Supported laboratory investigations and lab events/incidents.

Scientist (Contract) 07/2010 to 09/2011

Novartis Pharmaceutical Companies, Inc East Hanover, NJ

Developed Assay and Impurities/degradation products HPLC method for IND drug product (sterile injectable dosage form). Designed stability studies, authored stability protocol, and analyzed stability samples.

Scientist (Contract) 12/2008 to 09/2009

Jacobus Pharmaceuticals, Inc Princeton, NJ

Developed Chiral Purity (Enantiomeric Excess), Assay, Impurities/degradation products analytical methods for intermediate, raw material, drug substance and drug product (oral solid dosage form). Supported synthetic process development for drug substance with reaction monitoring, potency, purity, and mass determination analytical support.

Performed IQ, OQ, PQ for HPLC instruments.

Sr. Scientist/Group Leader 12/2003 to 12/2008

Par Pharmaceutical Companies, Inc (Kali Labs) Spring Valley, NY

Executed CMC section for ANDA projects from initial stage of development to final FDA approval with one direct report and two to three on an ongoing basis. Managed project planning, timelines, experimental design, data evaluation, coordinated R&D support studies. Involved in product development team meetings. Developed Assay, Chiral Purity (Enantiomeric Excess), Impurities/degradation products, Residual Solvents, Cleaning methods for drug substances and drug products (oral solid dosage forms). Approved test methods for validation. Designed, executed method validation protocols and authored validation reports. Transferred analytical methods from AR&D to QC and API manufacturer. Performed in-depth review of method validation data, reports, laboratory notebooks, and analytical services release and stability data. Trained and lead entry-level chemists in different analytical techniques.

Research Associate 08/2001 to 11/2003

Aurobindo Research Center Hyderabad, India

Developed Assay, Impurities/degradation products analytical methods for intermediates, starting materials, APIs and finished products (oral solid dosage forms). Designed, executed method validation protocols and authored method validation reports. Managed projects by providing analytical support (reaction monitoring, potency, purity) to the drug synthesis team.

QC Chemist 02/1997 to 08/2000

Dr. Reddy's Laboratories Limited (Cheminor Pharma) Hyderabad, India

Analyzed raw materials (API's and Excipients), primary, secondary packaging components, In-process materials, finished products (oral solid dosage forms), stability samples and qualified secondary working standards by various chemical tests and wet chemistry. Prepared and updated standard test procedures, specifications, general test procedures for primary, secondary packaging components, raw materials (API's and In-active), In-process materials, finished products and stability products, very well conversant with Ph. Eur, USP, US PF, Pharmeuropa, many literature books, patents, publications, abstracts and scientific journals.

Education

Master of Science: Applied Chemistry

Andhra University Visakhapatnam, Andhra Pradesh, India

Bachelor of Science: Mathematics, Physics, Chemistry

Kakatiya University Warangal, Telangana, India

Legal Work Status

US Citizen

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