| Candidate Information | | Title | Supply Chain Project Management | | Target Location | US-OH-Blue Ash |
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Click here or scroll down to respond to this candidatePROFESSIONAL EXPERIENCE SUMMARYProfessional experienceIndividual with integrity, knowledge, leadership, and teamwork enthusiast34+ years of experience, with many years in executive leadership roleExperienced in the pharmaceutical, biotechnology, vaccines, and ATMPsHands-on with global experience and knowledge of the industry and regulatoryCareer ExperienceHighlightsBusiness savvy has strong acumen of financial, manufacturing, logistics, supply chain, regulatory, and operationsExcellence in Program and project management: Directing projects, finance, schedules, and controlDemonstrated strong leadership of large, diverse, multi-national projects delivering high quality servicesComplete Procurement Services National and International from inception and negotiations to delivery, installation and start-up, including vendor visits during construction and FATExtensive and diverse international experience on expatriate assignments (9.5 years in EU and 2.5 years in South America)Executed projects implementing Six Sigma and lean manufacturing platforms processes and applicationsLeading technologies evaluation and implementation, e.g.; continuous manufacturing, Industrie 4.0/IIoT, ATMPs/C>sExperienced in CMC, US-BLA, EU-MAA, risk assessment (ICH Q9(R1)), and ICH Q12 requirement preparation, implementation, and regulatory representationMeeting with regulatory representing organizations as part of the regulatory teamPerformed extensive work in the development, scale-up, scale down and scale out and technology transfer for biologics (R&D and commercial manufacturing)Excellence in improving CAPEX and OPEX by planning and managing the life cycle of projectsParticipant in creating and implementing leading technologiesResolving 483s (FDA)/Warning Letters (EMA), Consent-Decree review and resolution, providing audits, risk assessments, and risk mitigationPublications PresentationsNumerous publications (Papers, Articles, Blogs and Books)Numerous presentations and lectures (USA and International)Robust interpersonal, written/verbal communications; collaboration skillsEducationIllinois Institute of Technology, Chicago, IL; (BS, Engineering Program)Illinois Institute of Technology, Chicago, IL; (MS, Engineering Program)Drexel University, Philadelphia, PA; (PhD, Biotechnology Engineering Program)Numerous Management and continuing Education CertificationsThe Excellence in Management CertificateContracting and Negotiation CertificateKepner and Tregoe, The Rational Manager certificateTQM CertificateProfessional AffiliationsRegistered Professional Engineer (PE) - NJ, PA, MA, NC, TXActive member of ISPE, and PDAEditorial Advisory Board: Pharmaceutical Processing, Pharmaceutical Manufacturing, Pharmaceutical Engineering, and Pharmaceutical TechnologyChaired, ISPE GUIDE: Biopharmaceutical Process Development and Manufacturing; publ. 2013; ISPE Sustainability Handbook; Pub. 2015, ATMPs Guide published 2021, Active participant member of Industrie 4.0/Pharma 4.0 SIG (DACH), Immediate Past Chair of ISPE-Guidance Document Committee (GDC-for 2 years), ISPE-Bioprocessing Conference-Planning Committee for seven years (Conference Chair, 2022)Presently contributing team member on revising PDA TR-60, [CPV-Continued Process Verification (FDA), Continuous Process Verification (EMA)] a Life Cycle Approach, and team chair for Stage 1, PDA PV IG Leader, PDA: Process Sub-committee past chair on Aging Facility Modernizations2012-2023ContractsConfidential Client, 1000 Oak, CAATMPs/CGTs project and Regulatory;Work Streams outlined below:o1. Review:SOPs, biosafety manual, product handling at siteo2. Risk Assessments:Description of final drug productNature of Biological starting materials (human vs animal vs microbial)Known infectious hazardsShipping materialso3.Training:Creation of training programTraining personnelConfidential Client, Columbus, OHAssist the client, Engineering and construction organization on an ATMPs (to serve as clinical product production site) project (Lentivirus Vector and AAVs)Confidential Client, Cincinnati, OHAssisted the client, Engineering, modular manufacturing and construction organizations on an ATMPs (to serve up to clinical trial II product production) project (Lentivirus Vector and Adenovirus Vector)Confidential Client, Fisher, IN Regulatory and Technology Lead representing the client and Project Team.Bridge Water, NJ; Gan & Lee Director of two large projects (US $2.5B, EU 3.5B) Aug 2018-Aug 2021.Cambridge MA, Brammer Bio - Multiple Products BLA-PAI Preparation and readiness team (Viral Vector Drug Substance/Drug Product). entails 20 different products from 20 different manufacturersOncobiologics, Cranbury, NJLead the preparation of document, risk assessment, statistical analysis design of experiment to support the BLA requirement and BLA planning and submissionChina based companyAssisted CEO on expanding their Biosimilar manufacturing platform into US and EU regions projects and site search and planning from clinical to product launch.Confidential Client; Moscow, Russian FederationGene Therapy; new and leading-edge technology and equipment/systems design and procurement. As well as clinical study and preparation for phase I, IA, and IIb.Confidential Client; Kuala Lumpur, Malaysia$200MM project, drug product manufacturing planning and review (vaccines, liquid and lyophilized), C&Q and process validation protocols preparation, regulatory compliance, process and manufacturing optimization of the manufacturing site (15 drug product/vaccines). As well as product review of the process, products for manufacturing feasibility and choice of manufacturing systems for Inactivated, attenuated, and live-virus vaccines, sterile injectable multi product project/site.Confidential Client; Astana, Kazakhstan (3.5B)Planning and scoping project, manufacturing of drug substance and drug product, multi-product, multi-dosage forms (biologics, sterile/aseptic, OSD, Ointment, creams, liquids, suspensions, and suppository). Planning CapEx and OpEx (5 years outlook), drug substance and drug products manufacturing planning and forecast for the manufacture and distribution to the local Market.Confidential Client; Moscow, Russian Federation (2.5B)oVery complex and large project/site (67 Hectares site) Master Planning and CapEx appropriationoEvaluated the list of drug substance and drug products forecasted for manufacture at this site (biologics: mammalian and microbial cell based fermentation, fill/finish-vials and syringes, OSD, suppository, and ointment)oSite planning (green site-forest at start), reviewed and evaluated space efficiency planning and optimization for manufacturingoAnalyzed and optimized process information vs. manufacturing facility.oReviewed manufacturing and optimized manufacturing Areas for optimum CapEx and OpExoDesign-build-validate 12 buildings on the siteoThis site to manufacture Drug Substance: mammalian and microbial cell-based processes (including a manufacturing building for cytotoxic biologics and ADCs)oSaved the client 230M by optimizing the product list (eliminated non-viable products), stream lined the processes, better manufacturing integration and site integration to minimize non-essential flow and unit operationsoSelected and interviewed vendors to provide process equipmentoProcured all process equipment and systemsoAssisted the Client to obtain manufacturing licenses [US-FDA, EU-EMA, and GOST]2012ContractsJANSSEN, JNJ Company; (Auditor and GAP analysis, risk assessment, 483s warning letters resolution)Aseptic Process Qualification engagement to help bring the Ben Venue Laboratories facility back on line and to address the product shortage that has become a very high priority for the company. The experts will contribute on sterile product and aseptic process manufacturing site qualification and validation at Ben Venue Laboratories on-site in Bedford, Ohio.oPerform QA walkthrough of sterile areas.oEnsure cleaning validation performed correctly.oPerform documentation review and release.oAuthor documents in support of sterile area.oAssist with preparation and document review.oOversee/authorize provisional and final release of sterile core materials.oConduct Aseptic Area Qualification.BIOCON, Bangalore INDIA; Reviewed manufacturing facility to determine the difficulty in reaching a passage in media fill and sterility issues. Evaluate clean in place, sterilization process of the complete system of reactors from Seeds to 30K L, and supporting equipment to reach a conclusion why the sterilization of the system is not effective and propose a solution to the sterility dilemma.2010 2011Vice President, Pharmaceutical & Biotechnology, x-nth/expResponsible for the process industry market including pharmaceutical and biotechnology business sector to grow and expand market share globally of the firm2007-2009Contracts (Director)BioMimetic Therapeutics Inc., Nashville, TNoProject director of project to plan, budget, design, procure, construct and validate a sterile syringe and vial manufacturing facility with all the necessary support and amenities2002 2006Director of European Operations, Lockwood Greene, Dublin, Ireland, & The Hague, NetherlandsOverhauled the Lockwood Greene European Operations P&L, expanding the operation and its capabilitiesoMarketed company services to clients and won new projects to improve backlog and declining revenueoRedirected the company and improved/grew operations in five to seven months through better servicing existing clients and bringing in new clients and new projectsoBuilt up the offices technical capability to provide services to clientsoRestructured management as well as the finance and legal departments2001Vice President, Pharmaceutical & Biotechnology, BE&KResponsible for the pharmaceutical and biotechnology business sector to grow and expand market share globally of the firm1997 2000Director of Pharmaceutical/Biotechnology Operations, Lockwood Greene, Various LocationsBrought on board to diversify the Cincinnati office with 200 employees, $26MM Gross Income, with multi-projects size ranging from $3K to $50MMoOffice was 100% dedicated to performing services for P&GoConverted the operation partially to a non-P&G projects base for office stabilityoDiversified the office to 70% performing work on a non-P&G projects in six months through rigorous marketing, applying experience and know-how of the Pharma/Biotechnology industry, presenting technologies applications, manufacturing, and operations know-how to bring in new clients and projectsoProject total book value approx $260MMOpened and operated new office/operation for Lockwood Greene to provide services to clients in Sao Palo, BraziloOffice was operational and self sustaining in a one years time (with approx 200 employees)Completed and restructured an acquisition in Argentina for Lockwood GreeneoAcquired company was an engineering operation performing services for the textile industry, which was non-existent in ArgentinaoGoal was to take the operation and convert it to an engineering house that performs service for the process industries i.e.: Pharma, Biotech, Chemicals, Oil, etc.oOperation was completed successfully in record timeOpened a satellite office in Rixensart Belgium for Lockwood Greene to provide project and technology services for SmithKlein Beechum Biologicals1995-1997Vice President Biopharmaceutical Division, Rust International, Inc., Birmingham, ALJoined a well-established company that was a leader in performing process projects for clients in the chemical, pulp and paper industriesVice President position was created to start a division that services the Pharma/Biotech/Process industrySuccessfully created a group of approximately twenty employees, establishing projects, and utilizing the common pull of employees for the general service1993-1995Director of Process and Validation Department, The Sigel Group PLC (Acquired by Jacobs Engineering Group), Narberth, PAExpanded the companys capabilities in the Pharma industry to provide process and validation services to their clientsConsolidated thirteen facilities in seven European countries for Wyeth operations into one operation in Newbridge, IrelandoManaged a team of engineers, external experts and vendors ($200M+ Project) to develop site search/selection, integration, design, construct and validate the facilityoLead the project from finding the site, design engineering, construction and validationoProject constituted of four major manufacturing suites grouping products based on their commonalities |
