Jaime M. Saenz-Larriuz, Mem, Pmp, Pmi-Rmp, Pmo-Cp Email and Phone Number
Jaime M. Saenz-Larriuz, Mem, Pmp, Pmi-Rmp, Pmo-Cp personal email
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Strategic Project and Portfolio Management, and PMO professional extensively trained and results driven with proven experience in capital projects and financials, new product introduction/launch, product transfer, quality and compliance projects, regulatory remediation projects, business transformation, processes improvement, Project Management Office (PMO), Portfolio Management implementation, trainings and benefits realization in the Pharmaceuticals, Medical Devices and Biotechnology industries.Successful results implementing Project Management Office (PMO), Project & Portfolio Management Governance and Business Transformation to support site objectives and business strategy. Established Project Risk Management, Benefits Management and Change Management to drive business excellence performance and operational efficiency as well as Project Management tools and trainings. Successful performance in regulated industries environment such as business as usual, growing the business (expansion, new product launch, product transfer) and license to operate (compliance and remediation activities such as Warning Letters and Consent Decree). Successful application of Lean and Six Sigma tools to achieve business transformation, process improvement and cost reduction in different business areas such as Manufacturing, Packaging, Supply Chain, Finance, Warehouse and Export/Import. Proven leadership, excellent team player, strong customer service and organizational skills. Proficient in training and coaching with the ability to influence and motivate. Bilingual (Spanish and English), excellent written and verbal communication skills. Computer Software: Office Suite, MS Project, SmartSheet, Instantis and others. Strong knowledge in AstraZeneca Project Management Framework (AZPMF) and Johnson & Johnson Flawless Project Execution (FPX) Project Management Framework. Promote and support leaders to develop and apply Project, Program, Portfolio Management, Change Management and Lean/6 Sigma processes to drive business excellence performance, operational efficiency and timely benefits realization to achieve their strategic competitiveness. I’m committed to partner with you providing knowledge, experience, and expertise in the amazing endeavor of business excellence performance to achieve extraordinary results.
Fujifilm Diosynth Biotechnologies
View- Website:
- fujifilm.com/fbsg
- Employees:
- 317
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Project Portfolio Manager - Capital ProjectsFujifilm Diosynth BiotechnologiesBryan, Tx, Us -
Project Portfolio Manager - Capital ProjectsFujifilm Diosynth Biotechnologies May 2024 - PresentBillingham, Gb -
Sr. Project Manager - Capital ProjectsFujifilm Diosynth Biotechnologies Nov 2021 - May 2024Billingham, Gb -
Project Manager - Capital ProjectsFujifilm Diosynth Biotechnologies Jul 2020 - Nov 2021Billingham, Gb● Capital Project Management on different business areas such as : - Quality Control (QC) - Manufacturing (MFG) - Product and Analytical Development (PD and AD) - Business Offices Tenant Improvement - Construction: GMP Warehouse, BOD MFG Building, Space Improvement ● CAPEX Project Portfolio and Financials Dashboard Management -
Quality Ops. Compliance Sr. Project ManagerPfizer Oct 2019 - Jul 2020New York, New York, Us● Managed successfully gLIMS Deployment Phase II (Raw Materials)● Managed updated site resources training profile for gLIMS Project.● Managed revision process for impacted SOPs to support gLIMS Go-Live!● Manage LIMS Deployment Phase III (Intermediates & Finished Products) -
Pmo Sr. Project ManagerPfizer Jan 2018 - Dec 2018New York, New York, Us• Managed end-to-end product launch projects (aseptic operation - injectables). • Lead Pre-Approval Inspection (PAI) Readiness for US and European markets (FDA, MHRA, ANVISA, AIFA). • Managed Printed Materials Project to comply with new regulatory requirements from Health Canada. Managed artwork revision to comply with Health Canada printed materials requirements as well as FDA serialization requirements.• Managed “Growth the Business Strategy”.• Support Site Business Continuity Program and Crisis Management Improvement. -
Project & Portfolio Management ConsultantJimmy Saenz & Associates Jan 2014 - Jan 2018Provides quality project management solutions and consultancy services in the following areas: Project Management, Program Management, Portfolio Management, Risk Management, Project & Portfolio Management Governance, Project Management Office (PMO), Organizational PM Maturity Level Assessment, Training, Business Transformation (Lean/6Sigma).
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Sr. Project ManagerEthicon, Inc. Aug 2015 - Dec 2017Raritan, Nj, UsProject Manager for Laboratory Operations:- Sample Management System Project- Laboratory Information Management System (LIMS) Project- Laboratory Equipment Qualification and Calibration Program Project- Test Method Validation Project• Definition and implementation of the Laboratory Equipment Qualification Remediation Project.• Manage a $20MM multi-site/global Test Method Validation Remediation Project.• Project staffing, budget estimate, scope and deliverables definition, scheduling development for a Test Method Validation Remediation Project in India. -
Sr. Project ManagerTherapeutic Proteins International, Llc Apr 2015 - May 2015End-to-End project manager for the research, development, testing (Toxicology Tests and Clinical Trials), validation and commercial launch of Adalimumab, a biosimilar recombinant protein product for rheumatoid arthritis treatment. Responsibilities also include equipment and facilities qualification as well as cleaning validation.
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Project & Portfolio Management And Pmo ConsultantJohnson & Johnson (Mcneil Healthcare, Llc.) Jan 2014 - Apr 2015New Brunswick, Nj, Us• Implementation and improvement of the Project Management Office (PMO) in a Consent Decree environment to improve Project Portfolio Management.• Manage projects for Packaging Technology Transfer, Product Launch Project, Regulatory Changes and Marketing Requirements.• Manage Business Continuity Projects such as label changes from supplier and supplier bottle mold relocation. -
Project Leader Ii / Oe LeadAstrazeneca (Ipr Pharmaceuticals, Inc.) 2008 - Dec 2013Cambridge, Cambridgeshire, GbSupport Site and Business Units Project & Portfolio Management and Business Transformation:• Responsible for the development and implementation of the Site Project & Portfolio Management Governance, Project Management Structure and Project Management Office (PMO).• Designed and facilitated Project Management trainings.• Developed and coached Project and Program Management Communities of Practice (PMCoP, PgMCoP).• Managed Solid Dose (Tablets and Capsules) and Product Transfer Projects.• Defined and established Regulatory Agencies Compliance Program as well as defined and established its CAPAs projects for remediation after FDA Inspection).• Distribution Warehouse Relocation Project (Footprint Reduction, Cost and Cycle Time Reduction) as well as the Start-Up and Operation.• Leading Finance and Planning & Warehouse Lean Transformations (Mini-Ts and Kaizen).• Business transformation and improvement opportunities identification and implementation. -
Process Engineering Group Team Leader (Supervisor)Astrazeneca (Ipr Pharmaceuticals, Inc.) 2001 - 2008Cambridge, Cambridgeshire, GbLeading Process Engineering Group to support Packaging and Manufacturing Operations :- Leading Process Engineering Group- Leading Technical Services SHE Team- Project Leader for new Pacakging and Manufacturing equipment and facilities qualificaton- Utilities Equipment and Facilities Qualification- Packaging Equipment Technology Transfer- Project Leader for new product launch and site start-up -
Process Engineering ProfessionalAstrazeneca (Ipr Pharmaceuticals, Inc.) 1995 - 2001Cambridge, Cambridgeshire, GbTechnical Services Support Manufacturing and Packaging Areas: - Manufacturing and Packaging Equipment Qualification- Manufacturing Equipment Factory Acceptance Test (FAT)- Utilities Equipment and Facilities Qualification- SOPs development and training- Packaging Equipment Technology Transfer
Jaime M. Saenz-Larriuz, Mem, Pmp, Pmi-Rmp, Pmo-Cp Skills
Jaime M. Saenz-Larriuz, Mem, Pmp, Pmi-Rmp, Pmo-Cp Education Details
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Project Management Institutte (Pmi)Scheduling Professional -
Project Management InstitureCertified Risk Management Professiona (Pmi-Rmp) -
American Society For Quality (Asq)Six Sigma Black Belt Academia -
Project Management InstituteCertified Project Management Professional (Pmp) -
Universidad De Puerto RicoBiostatistics -
Universidad Politécnica De Puerto RicoEngineering Management -
Universidad De Puerto RicoChemical Engineering -
Louisiana State UniversityAccounting And Finance
Frequently Asked Questions about Jaime M. Saenz-Larriuz, Mem, Pmp, Pmi-Rmp, Pmo-Cp
What company does Jaime M. Saenz-Larriuz, Mem, Pmp, Pmi-Rmp, Pmo-Cp work for?
Jaime M. Saenz-Larriuz, Mem, Pmp, Pmi-Rmp, Pmo-Cp works for Fujifilm Diosynth Biotechnologies
What is Jaime M. Saenz-Larriuz, Mem, Pmp, Pmi-Rmp, Pmo-Cp's role at the current company?
Jaime M. Saenz-Larriuz, Mem, Pmp, Pmi-Rmp, Pmo-Cp's current role is Project Portfolio Manager - Capital Projects.
What is Jaime M. Saenz-Larriuz, Mem, Pmp, Pmi-Rmp, Pmo-Cp's email address?
Jaime M. Saenz-Larriuz, Mem, Pmp, Pmi-Rmp, Pmo-Cp's email address is jaimesaenz@me.com
What schools did Jaime M. Saenz-Larriuz, Mem, Pmp, Pmi-Rmp, Pmo-Cp attend?
Jaime M. Saenz-Larriuz, Mem, Pmp, Pmi-Rmp, Pmo-Cp attended Project Management Institutte (Pmi), Project Management Institure, American Society For Quality (Asq), Project Management Institute, Universidad De Puerto Rico, Universidad Politécnica De Puerto Rico, Universidad De Puerto Rico, Louisiana State University.
What skills is Jaime M. Saenz-Larriuz, Mem, Pmp, Pmi-Rmp, Pmo-Cp known for?
Jaime M. Saenz-Larriuz, Mem, Pmp, Pmi-Rmp, Pmo-Cp has skills like Six Sigma, Quality Management, Project Management Tools, Lean Manufacturing, Computer System Validation, Root Cause Analysis, Gamp, Gmp, Gxp, Change Control, Regulatory Affairs, Standard Operating Procedure.
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