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I love to build things and lead change.CAREER OVERVIEW: Tenacious, decisive, and data-driven Pharmaceutical Leader, SOP writer, experienced Licensed Clinical (R.Ph) and Authorized Nuclear Pharmacist (ANP), proven leader in design, development and commercialization of pharmaceutical manufacturing. Experienced, result-driven healthcare professional with extensive expertise of cGMP, GCP, GDP, USP Chapters 797 and 800. Passionate proponent of value-based, collaborative pharmaceutical care management and outcomes-focused clinical practices. LEADERSHIP STYLE: Inclusive influencer of uncompromising integrity in management, inspiring team performance and internal/external partnership-building. Servant leader who motivates high-performing teams to outpace timelines, exceed patient care expectations, and fuel organizational healthcare transformation.HEALTHCARE ROI: Conceived and delivered strategic initiatives to drive adoption and optimize utilization of healthcare regulations and SOPs. Road-mapped launch of first FDA-approved 503B Pharmaceutical Compounding Center in Massachusetts. Proven track record of cost savings and fiscally responsible decision making.
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Pharmacy Manager Of Sterile CompoundingTufts Medical Center Jul 2021 - PresentBoston, Ma, Us● Expertise in USP797, USP800, risk assessment and federal laws, rules and regulations to ensure quality compliant sterile, non-hazardous and hazardous drug compounding● Building efficient teams and leading cross-functional communication● Successfully prepared, obtained DPH approval and launched a Segregated Compounding Area in November 2021 and a new state-of-the-art Central Pharmacy cleanroom in May 2022● Lead the Sterile Products Area Team and provided Tufts Medicine system-wide support to launch EPIC in April 2022● Key system-wide decision maker for the Tufts Medicine Sterile and Non-Sterile Compounding and Repackaging Committee● Establish safe and effective Medical Center sterile compounding programs, inclusive of new inpatient and outpatient sterile compounding services● Evaluation and implementation of all technologies utilized in the practice or oversight of sterile compounding, safe handling of hazardous drugs, or controlled substance programs● Oversee 30 personnel including Pharmacy Technicians, Pharmacists and Pharmacy Interns● Chair on the Sterile Products Oversight Committee and sit-in-on the Infection Control Committee, P&T and Operational Excellence Committee -
Director Of PharmacyAdvanced Compounding Solutions Mar 2019 - Jul 2021● Developed and authored hundreds of regulatory documents including SOPs, sterile compounding processes, process validations, master formulation records, administrative policies and regulatory processes in accordance to cGMP, FDA, ICH, DEA and USP 797/800 guidelines.● Ideated, coordinated and worked with the leaders, internal and external stakeholders, and team members to design new systems, processes and drove innovations to launch new product activities.● Subject matter expert in launching Company in mid-2017, achieving revenue of $1M by end of 2017. ● Set the stage and contributed to Company 2018 revenue of $8.6M, 2019 revenue of $12.8M, 2020 revenue of $12M and 2021 revenue of 17M.● Expertise in regulatory documentation compliance of FDA, DEA, BoP and other federal and state licensing authorities.● High efficiency in authoring, reviewing and approving SOPs, Quality Improvement Plans, Process and Media-Fill Validations, regulatory, quality reports such as CAPAs, Change Controls and Non-Conformances.● Directed the planning, coordination and control of all manufacturing and compounding processes, including significant contributions to software product development.● Investigated and explored new technology and concepts for potential application within our product portfolio and adjacent spaces, driving market leadership and portfolio expansion.● Hired, trained and mentored compounding staff in following policies, procedures and conducting daily operations.● Supervised inspection and examination of sterile compounded preparations to ensure that highest quality standards are maintained.● Formulated pricing of product catalog and sterile compounding modalities.● Formulated pharmaceutical preparations, applied dosage form calculations and implemented data analysis.● Runner-up company-wide 2017 New England Life Care / Advanced Compounding Solutions Employee of the Year.
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Associate DirectorAdvanced Compounding Solutions Oct 2018 - Mar 2019
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Production ManagerAdvanced Compounding Solutions Oct 2016 - Oct 2018
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PharmacistHallmark Health System, Inc. Apr 2016 - Sep 2017Medford, Ma, Us● Performed unit-based pharmacist duties on all hospital units including Central Pharmacy, Intensive Care Unit, Med/Surge, Emergency Department, Pediatrics, Labor and Delivery, Psychiatry. Remotely conducted pharmacy operations for Lawrence Memorial Hospital.● Implementation of drug protocols: dosing, preparation, side effect, therapeutic management and documenting interventions through Quantify and Sentry7.● Responsibilities included renal, hepatic and body surface area dosage adjustments, therapeutic interchanges, IV to PO substitutions, opioid conversions, and pharmacokinetic calculations for vancomycin, gentamicin, and phenytoin dosing.● Consultations and implementation of anticoagulation protocol management, including pharmacy dosing of Coumadin, Lovenox, and patient education. ● Managed technicians, acted as universal pharmaceutical informational resource for physicians and other healthcare providers, verified orders, checked complete preparations for accuracy, distributed scheduled and unscheduled medications throughout hospital. -
Nuclear Pharmacist And Quality Assurance LeadGe Healthcare Aug 2007 - Mar 2016Chicago, Us● Executed and ensured Process Validations, environmental monitoring, aseptic techniques and cleanroom operations per USP 797 standards, including maintenance and sterility testing. ● Used analytical equipment and chemical tests to ensure Quality Control. Performed preventive maintenance and ensured calibration of instruments used in daily operations. ● Maintained all applicable documents and records. ● In collaboration with DEA, FDA and DPH officials, locally designated in 2011 to launch distribution of DaTscan, the first and only radioactive imaging agent and controlled substance (CII) used to successfully diagnose Parkinson's Disease.● In compliance with federal and state pharmacy laws, applicable licensing authorities (including Radiation Safety, US Department of Transportation, Joint Commission, etc.) and corporate policies and procedures. ● Produced, tested, dispensed and shipped sterile and non-sterile radionuclide compounds per USP 795 and 797 standards.● Managed and operated clean room, radionuclide generators, QC equipment and associated software. -
Executive Team Leader - Pharmacy ManagerTarget Dec 2005 - Jul 2007Minneapolis, Mn, Us● Interviewed, hired, trained, mentored and supervised pharmacists, interns and technicians. Managed all federally-controlled (CII-CV) and Massachusetts-controlled (CVI) substances in accordance with all applicable regulations and maintained tight inventory control of the same. ● Increased pharmacy volume and revenue by over 100% YOY. ● Successfully met time-critical deadlines, handled inspections and pharmacy-related legal matters. Adopted new and more efficient strategies to improve and streamline workflow. ● Earned the Operational Performance and Team Development Award and Guest Excellence Award for the Northeast US region in 2006. -
Staff PharmacistOsco Drug/Brooks Eckerd Pharmacy Oct 2001 - Dec 2005● Dispensed, compounded and ordered medications, including all controlled substances, transferred prescriptions, handled incoming physician calls, performed Drug Utilization Reviews, inventory control and completed paperwork required by Pharmacy Operations. ● Supervised pharmacy interns and pharmacy technicians. Interviewed prospective staff.
Marco Romano Skills
Marco Romano Education Details
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Purdue UniversityNuclear Pharmacy Postgraduate Program -
Northeastern UniversityPharmacy -
Sapienza Università Di RomaGeneral -
Università Di Napoli L'OrientaleGeneral -
Liceo Linguistico "W. Shakespeare" - Formia, ItalyGeneral
Frequently Asked Questions about Marco Romano
What company does Marco Romano work for?
Marco Romano works for Tufts Medical Center
What is Marco Romano's role at the current company?
Marco Romano's current role is Healthcare Leader.
What is Marco Romano's email address?
Marco Romano's email address is mr****@****lth.org
What is Marco Romano's direct phone number?
Marco Romano's direct phone number is +178139*****
What schools did Marco Romano attend?
Marco Romano attended Purdue University, Northeastern University, Sapienza Università Di Roma, Università Di Napoli L'orientale, Liceo Linguistico "w. Shakespeare" - Formia, Italy.
What are some of Marco Romano's interests?
Marco Romano has interest in Diy, Cooking, Trading Equities, Investing, Gardening, Traveling, Wine Making.
What skills is Marco Romano known for?
Marco Romano has skills like Healthcare, Pharmacy, Healthcare Information Technology, Pharmacists, Healthcare Management, Patient Safety, Nuclear Pharmacy, Managed Care, Management, Pharmaceutical Industry, Medication Therapy Management, Hospitals.
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