Bryan Lucero Email & Phone Number

Ma, 01824, Us

North Billerica, Massachusetts, Us

- licensing of respiratory ventilators in Canada, Philippines, Brazil, Mexico, Colombia, and Argentina- acting as Regulatory representative in the design and development of CPAP for obstructive sleep apnea with responsibilities for its licensing in US, Canada, EU and ROTW.

- enabled effective implementation of Quality Management System for a start-up medical device client using electronic collaboration and documentation tools- assisted in regulatory strategy and preparation of 510(k)s for implantable endodontic devices and responded to FDA communications regarding licensing submissions and device manufacturer's GMP compliance.- supported a cross-functional project team assigned for the transfer of Marketing Authorizations of four approved biopharmaceuticals between two global life science organizations- collected, analyzed and summarized all Adverse Event and Recall occurrences for metal-on-metal hip implants within the US, Canadian and EU markets as a sub-section in a Safety and Effectiveness Summary required per Letter to Industry by the FDA for metal-on-metal total hip implant manufacturers.- engineered, proceduralized and helped roll-out Quality Control and Quality Assurance systems for a start-up biopharmaceutical company

Bedford, New Hampshire, Us

-supervised the QC testing for a CDMO with a growing number of clients, initially as an A Shift Supervisor (Sun-Wed) with 3 direct reports, then eventually as single shift (Mon-Fri) with 6 direct reports-dependably provided QC test results for various drug substances and drug products on time for both NH and WI manufacturing locations-implemented efficiencies in the QC operations including scheduling of routine tests via “rhythm wheel”; online management and forecasting of group schedule using Smartsheets, and the reporting of quarterly increases in QC capacity and throughput-prioritized closure of Quality System Events (deviations, out-of-specifications, CAPA) and implemented action items by authoring and revising SOPs for QA process customers in line with corporate goals

- owned business to assist in the registration of dental implants within the ASEAN framework- operated an 18-room guesthouse in Patong Beach, Phuket

Cambridge, Ma, Us

- developed and implemented a harmonized quality management system for a combination device/drug/tissue company for effective compliance to divergent international regulations - authored, collaborated and managed regulatory submissions for USA, Canada, EU, Australia, and Korea within expected timeframe, including licensing for HCT/P (human cells, tissues, and cellular and tissue-based products)- project manager for business-critical projects with objectives ranging from the successful licensing and launch of a new product to the implementation of a compliant internal distribution and marketing operations-- QA responsibilities include management of Harmonized Technical Documentation, Quality Auditing, Risk Management, Corrective and Preventive Actions program, and Supplier Evaluation.- QC responsibilities include management of Quality Control department that has increased QC cycle time up 33% from previous year’s performance two years in a row- attended seminars on EU Medical Device Approval, FDA on Combination Products, Reimbursement, Sterilization Validation, LAL Testing, to name a few

Mumbai, Maharastra, In

- supervised a QC laboratory of 8 analysts for QC testing of raw material, in-process, final product, and stability samples for compliance to cGMPs while keeping business expectations for timeliness and throughput- managed cross-functional projects responsible for the technology transfer of newly-acquired products and raw materials (one in 1999, and then another in 2004) ahead of expected deadline - created, executed, and reviewed numerous technical documentation regarding company products and processes with strict adherence to all applicable quality system regulations and guidelines- established computerized administration programs using MS Access for equipment calibration, characterization of standards, and QC sample submissions and allowed for Crystal Reports-based Pareto analysis, process control charting, and other performance indicators- served as a member in company Internal Auditing Committee and Safety Committee

Wilmington, De, Us

- supported radiopharmaceutical biodistribution studies in rabbits and monkeys using HPLC and cell culture techniques- helped develop and validate purity assays for a lipid-based drug candidates using evaporative light-scattering detection-HPLC

- helped mobilize resources for a newly-established shelter for mentally-ill/homeless male in the Greater Lowell area using community resources and the Office of Community Service at UMass - participated in recruiting consumers (residents) for the shelter

Ms, Engineering Management

Bs, Biological Science