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High-performing senior leader with over 20 years of experience in pharmaceutical and biotechnology industries. Demonstrated leadership and accomplishments in translating business vision into positive outcomes through efficient & effective application of Project Portfolio Management (PPM) and Operational ExcellenceSPECIALITIES• Drug discovery, development and commercialization• Project leadership fundamentals and best practices with PMP certification• Governance, Stage Gate-based NPI framework and project team empowerment • Due Diligence (DD) and strategic alliance management • Oncology, immunology, neurology, cardiometabolic disorders, rare & infectious diseases • Biologics, cell & gene therapy, small molecules, nucleic acids & peptides, drug/device combinations• In vitro diagnostics, medical devices and consumable/reagent development • Manufacturing process development and validation (cGMP and Six Sigma) • Regulatory submissions and compliance {IND/IDE/CTA, NDA/BLA/MAA, 505(b)(2), 510(k), 21 CFR Part 11}• Cost-benefit analysis, risk management and Change Execution Management (CEM)• Business and scientific acumenCAREER HIGHLIGHTS • Leadership and Team Building: Led and Built > 30 high-performing cross-functional Project/Program Teams across 3 different industries (Pharmaceuticals, Diagnostics & Life Sciences) • Project Delivery: Led or contributed to > 40 new product launches from early concept to commercialization with a combined revenue exceeding $2B (new indications, label expansions, IVD, life science products); led/supported numerous IND/IDE/CTA and NDA/BLA/MAA submissions• Business Process: Established a new organizational design at Merck Vaccine Manufacturing Division and implemented Stage-Gate NPI framework at GE Healthcare and United Neuroscience • Subject Matter Expert: Through accumulative experiences from companies of varying sizes, developed a comprehensive set of methodology, processes and tools in project, program & portfolio management that can be applied to virtually any type of organization (PPM Tool Box)
Advanced Ppm Consulting, Llc
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Founder/Principal ConsultantAdvanced Ppm Consulting, Llc Dec 2019 - Present• Advanced PPM Consulting, LLC is a specialized consulting firm focused on implementing innovative project, portfolio and operational excellence best practices for its pharmaceutical and life science partners• Key offerings include PPM capability building, governance and operating model, R&D roadmap per Stage Gate and portfolio prioritization, optimized path from strategy to execution, CMC and Clinical program management (Ph I to IV), alliance management, regulatory submissions, commercial launches, “Fit-for-Purpose” PPM systems and tools implementation• Previous engagements at BMS Oncology/Hematology, Vertex Cell and Genetic Therapies (VCGT) and Gates Medical Research Institute (mAbs and vaccines)
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Sr. Director, Program ManagementSenda Biosciences Jul 2023 - Jan 2024Cambridge, Massachusetts, UsSenda is on a mission to bring life-changing treatments to patients by using nature’s codes to fully program medicines, potentially unlocking new levels of speed, breadth, and productivity in the development of advanced therapies. -
Sr. Director, Project Management & Project ExcellenceElevatebio Mar 2022 - Jun 2023Waltham, Massachusetts, UsElevateBio is powering transformative cell and gene therapies today and for many decades to come. Elevate right from the start - Project & Portfolio Mgt (PPM) Team is an integrated part of this transformation by leading and supporting project/program teams from discovery to clinical development across the entire Elevate portfolio! -
Head Of R&D Operations And Project Portfolio ManagementUnited Neuroscience Jan 2018 - Dec 2019Dublin, Dublin, Ie• Responsible for establishing R&D governance/infrastructure and leading company’s flagship development programs (against Alzheimer’s Disease & Parkinson’s Disease) across all UNS’ global locations (US, EU and Asia)• Implemented various PPM best practices including formulation of R&D strategy, Stage-Gate framework (Project Team Guide), 1-yr/3-yr/10-yr development roadmap and portfolio prioritization• Served as Site Head for vaccine product development, platform technology/translational science, CRO/CDMO management, CMC and clinical supplies -
Director, Project ManagementFerring Pharmaceuticals Jun 2015 - Jan 2018St-Prex, Ch• Established highly-skilled and energized Project Teams with clearly defined vision, growth strategy and operating mechanisms in meeting Ferring’s 5-year Business Plan• Implemented a comprehensive drug development methodology to conduct successful clinical trials (Phase II to IV); proactively addressed all key factors that may impact product safety, efficacy, compliance, enrollment and reimbursement • Coordinated an coherent team effort in developing a compelling value proposition and target product profile; generated “Engagement Plan” for CROs, CMOs, Key Opinion Leaders, consultants and strategic partners • Assisted Regulatory Leads in conceiving regulatory strategies for a device-drug combination asset (Modular Approach) and a prostate cancer drug label change via the 505(b)(2) route• Partnered with Business Development (BD) by leading Due Diligence Teams to evaluate external opportunities -
Project LeaderGe Healthcare 2011 - 2015Chicago, Us• Provided leadership and in-depth project management expertise to 3 Clinical Program Teams concurrently in conducting Phase II to IV clinical trials as defined by Project Charter, timelines, budgets and ICH/GCP guidelines • Served as the single point of accountability for all operational aspects of the Project Teams (e.g., from strategy to execution, scenario analysis, study design/protocol, Ad Board, Investigator Meetings, ADI & Risk Logs)• As Lead Program Integrator, spearheaded a company-wide effort in assisting the Executive Team to implement GEHC’s Phase Review Discipline (PRD) customized for the pharmaceutical imaging business -
Lab Manager (Tech Ops), Production Supervisor And Team Leader (Drug Discovery And Development)Merck, Promega And Innovir 1995 - 2011• CMC, cGMP Manufacturing and Tech Transfer Experiences at Merck Vaccine Manufacturing Division and Promega Corporation (over 9 years of combined experiences)
Michael Ma Skills
Michael Ma Education Details
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National Research Council CanadaMolecular Biology -
University Of Colorado BoulderNucleic Acids Chemistry
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Université Catholique De LouvainBio-Organic Chemistry
Frequently Asked Questions about Michael Ma
What company does Michael Ma work for?
Michael Ma works for Advanced Ppm Consulting, Llc
What is Michael Ma's role at the current company?
Michael Ma's current role is Project Portfolio Management | R&D Operations | CMC | Regulatory Submissions | Pharmaceutical & Life Science Consulting.
What is Michael Ma's email address?
Michael Ma's email address is mi****@****hoo.com
What is Michael Ma's direct phone number?
Michael Ma's direct phone number is .973.796*****
What schools did Michael Ma attend?
Michael Ma attended National Research Council Canada, University Of Colorado Boulder, Université Catholique De Louvain.
What skills is Michael Ma known for?
Michael Ma has skills like Cross Functional Team Leadership, Pharmaceutical Industry, Project Management, Process Improvement, Life Sciences, Leadership, Gmp, Medical Devices, Validation, Six Sigma, Strategy, Management.
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