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SummaryQuality Assurance, Analytical, and Stability professional with over 30 years of experience in Pharmaceutical Analytical R&D, Quality Control, Quality Assurance, CMC, Metrology and people management in pharmaceutical, Chemical and Contract Research Organization. Innovative, efficient, highly motivated with sharp analytical and problem solving capabilities. Comprehensive industry knowledge with effective interpersonal, communication, troubleshooting, technical writing, and presentation skills. Experienced in performing and managing analytical method development and method validation for solid, semi-solid, liquid and suspension. Extensive experience in the quality control and quality assurance of pharmaceuticals, cosmetics, organic chemicals, metals, minerals, oils, fats and soaps. Thorough knowledge of FDA, ICH, and USP guidelines. Strong background in cGMP’s and application to pharmaceutical development. Extensive knowledge in handling Schedule II controlled substances in accordance with DEA regulations.Goals: leadership position in Quality Control, Quality Assurance, Regulatory affairs or in pharmaceutical project management
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DirectorBristol Myers Squibb Nov 2023 - PresentLawrence Township, Nj, Us -
Associate Director Quality AssuranceBristol Myers Squibb Oct 2012 - Nov 2023Lawrence Township, Nj, UsAssociate Director of Development QA-CMC Small Molecules. Senior Manager Stability (Phase 1, II, III and IV) and Reference Standards
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FellowNovartis Jun 2006 - Oct 2012Basel, Baselstadt, Ch•Analytical Expert for development projects in various stages of development (Pre-Poc to Phase IV). Manages all activities to generate documentation for IND/IMPD, NDA, Stability, Specification and Analytical methodology. Manages internal and external associates to achieve target deliverables.•Project leader for one late phase and one early phase project: Managed all formulation, analytical and financial activities and completed all activities ahead of time for filing and received FDA approval for the Late phase project. The early phase project is in PoC.•Interacted with Health Authorities at various occasions to resolve analytical issues as an Analytical Expert and received successful out come for various projects •As dissolution Lab head, simultaneously managed about 25 projects in various phases of development. Witten responses to Health authority questions, resolved technical issues related to analytical issues at various stages including transfer, scale up and post launch.•Supervised 6-8 direct reports who perform methods development and methods validation, including assigning, reviewing and discussing analytical work/documentation, guiding in setting realistic/challenging goals and objectives for each year, assisting in trouble-shooting, counseling, training, mentoring and increased productivity out put, writing/conducting annual performance evaluations. -
Technical Group LeaderBarr Laboratories 2005 - 2006•Managed various Quality control laboratory activities and directly supervised 8 analytical scientists, who routinely tested drug substance, excipients and drug products for commercial use.•Managed data review staff and met quality and productivity guidelines for commercial drug product supply.•Routinely interacted with QA, cGMP functions product release, deviations, investigations.•Resolved personnel and technical issues in a timely fashion for quality enhancement and to set high employee morale standards.•Authored and reviewed several technical documents and SOPs for various QC functions
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Principal ScientistPurdue Pharma 2001 - 2005Stamford, Ct, Us•Supervision of 4 direct reports who perform methods development and methods validation, including assigning, reviewing and discussing analytical work/documentation, writing/conducting annual performance evaluations, guiding in setting realistic/challenging goals and objectives for each year, assisting in trouble-shooting, counseling, training, mentoring and increased productivity out put.•Independently developed/performed complex analytical procedures such as MS compatible HPLC methods, Forced degradation, Robustness and Mass Balance studies utilizing appropriate analytical instrumentation for the timely filings of CMC, IND, NDA and sNDAs.•Utilized state-of-the-art techniques such as NIR to implement Process Analytical Technology to measure assay, blend uniformity, moisture and dissolution of pharmaceutical products and saved cycle time for batch manufacturing. •Internally recognized expert on method validation, HPLC trouble shooting, Dissolution and NIR testing and trained several junior staff in the department.•Represented the Pharmaceutical Analysis department during pre approval inspections by the FDA to answer their questions and findings.•Authored several methods, validation and stability reports, procedural exception requests, Laboratory Data Assessments, investigations, notebooks and assay addendums for the scheduled filings of CMC, IND and NDA.•Coordinated technology transfer of several HPLC assay, dissolution and cleaning methods to manufacturing and quality control and CRO sites for the timely manufacture of clinical and process validation batches. -
Senior ScientistPurdue Pharma 1997 - 2001Stamford, Ct, Us•With limited supervision, conducted complex laboratory procedures such as assay, related substances, dissolution and other physical and chemical tests using appropriate instrumentation with high speed and accuracy.•Interpreted and summarized analytical data for formulation development and stability assessment for quick and easy decision making to promote the product development phase.•Represented department on project teams, sub teams and task forces as an advocate for the department to communicate the departmental interests and to quickly achieve company goals.•Recommended and developed new technology for automated preparation and assay for solid dosage form using Tablet Processing Workstation (TPW) and improved productivity.•Authored several calibration procedures, trained the department and calibrated equipments as per cGMP standards for the full compliance with FDA regulations.•Audited GLP study notebooks and raw data for regulatory compliance
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Associate Senior ScientistPurdue Pharma 1991 - 1997Stamford, Ct, Us•Demonstrated in-depth understanding, increased working knowledge and ability to independently perform analytical methods for assay, dissolution, related substances etc. to quickly clear the stability and experimental samples for analysis.•Calibrated, maintained and trouble shooted analytical instruments to assure accuracy and precision in accordance with cGMP.•Independently calculated and processed scientific data for formulation and stability assessment.•Presented scientific data at department and other meetings to enhance communication within the department
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R&D SupervisorKedia Chemicals 1989 - 1991•Supervised 3 chemists in the analysis of organic chemicals using GC and wet chemical methods.•Undertaken planning, method development and validation and plant support for the manufacture of organic chemicals.•Optimized the synthesis of ethyl acrylate, phenyl ethyl alcohol, ethylene glycols and ethylamines.•Resolved issues with external customers related to quality of the products shipped by the company
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Analytical ChemistGeo Chem Laboratories 1985 - 1989•Analyzed drugs, metals, minerals, oils, fats, oil cakes, soaps, coal and petroleum products for purity and content using various techniques including HPLC, GC and UV spectrophotometer; Flame photometer, Potentiometer, wet chemical, gravimetric and calorimetric methods•Performed complete raw material testing as per European Pharmacopoeia for external clients
Roy Paul Skills
Roy Paul Education Details
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New York University - Polytechnic School Of EngineeringChemistry -
Ruia CollegePharmaceutical Sciences
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St Albert'S CollegeChemistry
Frequently Asked Questions about Roy Paul
What company does Roy Paul work for?
Roy Paul works for Bristol Myers Squibb
What is Roy Paul's role at the current company?
Roy Paul's current role is Director CMC Quality.
What is Roy Paul's email address?
Roy Paul's email address is rp****@****ene.com
What is Roy Paul's direct phone number?
Roy Paul's direct phone number is +190872*****
What schools did Roy Paul attend?
Roy Paul attended New York University - Polytechnic School Of Engineering, Ruia College, St Albert's College.
What skills is Roy Paul known for?
Roy Paul has skills like Paharmaceutical Analysis, Pharamaceutical Project Management, Quality Management, Pharmaceutical Quality Control, Pharmaceutical Quality Assuarance, Fda Regulations, Metrology, Pharmaceutical Research, Regulatory Submissions, Quality Assurance, People Management, Hplc Method Development.
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