Committed to finding solutions within all discipline's client growth strategies, and opportunity identification within the life sciences. Partnering and sharing expertise joining a winning company, Unicon Pharma, an organization committed to attracting and retaining the brightest minds in Life Sciences who share our passion for bringing life-changing medicines, therapies, and products to market. We focus exclusively on Life Sciences—nothing else. From our inception, we’ve maintained a singular focus on connecting the brightest minds in life sciences. We leverage our experienced, customer-facing team, vast network of 180,000+ Life Sciences professionals, and relationship-first approach to become your trusted advisor and empower you to achieve your hiring and business goals. We’ll work closely with you to listen to your needs, consult you on the most strategic solution, and partner with you to deliver that solution.

Managing EG Life Sciences brand and capabilities throughout North America and driving growth within client companies while uncovering opportunities throughout Client/EG Life Sciences network. EG provide strategic and innovative solutions to the Pharmaceutical, Biotechnology, Medical Device and Diagnostics industries. Innovative and dynamic firm with an excellent resource profile building partnership with top industries providing the ability to comprehensively understand the challenges and gaps to deploy the best fit Consultants on multiple projects. EG Eliassen Group, a Life Science Division Company with an excellent SME's portfolio within the consulting business.

Lead and deliver PMO project timeline objectives including successful delivery of the site Regulatory supporting other Non-Regulatory Commitments. Project Management Oversight of Site Remediation as well as Business Unit support not limited to associated work streams and projects. Ensuring milestones and plans are established and tracked, risks are identified and projects are resourced. Review performance against commitments weekly with the Site Leadership Team, put in place corrective actions where commitments are at risk and assist with update weekly Governance reviews. Directly manage different workstream (Smoke Studies, Autoclave Projects) project timeline, resources, recruitment process as necessary as well as facilitating material, tools and technology to achieve project goals following regulatory commitments.Act as liaison with Remediation and Site Stakeholders and ensure timely communication and project status updates.Manages onboarding of new hires & contract staff as necessary aligned with Site Lead.Identify improvement and enhancement opportunities for products and processes as work streams progress. Provide leadership to strategic Operations projects cross functionally, partnering with key remediation and site stakeholders.Lead workstreams / support resources team and provide oversight and ensure execution of the PMO governance and stage gate process for all projects.Present project status/issues/risks to site leadership members and provide recommendations on project direction as necessary.Leads cross-functional teams in the delivery of site remediation projects. Responsible for all aspects of project management and delivery.Provides oversight and leadership to ensure that projects are completed on time. Responsible for workstream phases of project management.

Lead and Coordinate project start up for the new LONZA Biologics, world's largest dedicated commercial cell-and-gene-therapy facility located at Houston TX, built in anticipation for cell and gene therapies – the next era in medicine to deliver treatments directly to patients around the world. Lead complete equipment/process validation, (IOQ, PQ, PPQ), project for the new equipment specifically for Cell-Therapeutics process, initiating validation runs from small to large scale commercial manufacturing.Consulting Role – • Coordinate clinical equipment/process Validation activities and executions; Manufacturing areas for new systems, equipment, and processes. • Lead and support commercial products schedule to comply with patient/market demands thru CMO operations. • Lead commercial validation readiness plan. Work closely with all functional areas to ensure readiness plan outcome and specifications accordingly with CMO demands. • Provide expertise in the coordination of multiple, complex, routine, and non-routine projects involving the planning, validation activities of processes, equipment, and systems. • Full validation cycle on Centrifuges, Nucleocounters, Freezer, LN2 Freezers, Class II BioSafety Cabinets, Terumo units, Wave Platforms, Bioreactors, among others.

Short Term Special Assignment - 483 RemediationPrincipal Role – • Collaborate and work in parallel with the current Cantrell's Director of Quality.• Initial audit to provide the necessary knowledge of the current Cantrell's Quality Systems and controls to be able to provide the necessary oversight of the lot release program.• Provide Quality oversight and recommendations to Cantrell Management of the lot release program.• Provide assistance as needed, with closing the gaps in the quality system based on a pre-approved project scope and deliverables.• Ensures identification and communication to Cantrell Management of project the risks, development of risk plan and leads core team in the proactive management of risk response strategies.• Evaluate the need of additional resources to support the Quality team strategies.• Generate a progress status report on a weekly basis.• Collaborate with Cantrell Quality Director and Senior Management to ensure accomplishment of the project goals and deliverables on a timely manner.

Manage and Coordinate pour, compounding re-packing validations/qualifications,(IOQ,PQ,PPQ),Engineering Studies for commercial new/legacy formulations (powder,oral solution,and suspensions),at VistaPharm a healthcare company that specializes in delivering pharmaceutical products directly to customer, hospitals retail pharmacies and clinical patients.Manage Validation team and support QIP,(Quality Improvement Plan) assessment and remediation including implementation of all process and systems.Project & Validation Manager-•Coordinate site Validation activities and executions; Engineering,Laboratory,Packaging and Manufacturing areas for new systems,equipment,and processes for new and legacy products/equipment/systems.•Lead and support commercial products schedule and coordinate resources to comply with market demands.•Work directly with Regulatory department on labeling requirements,specific packaging components and system design.•Lead commercial product readiness plan.Work closely with all functional areas to ensure readiness plan outcome and specifications accordingly with regulatory requirements.•Attend management meetings,new commercial product launches,project plan,readiness,QIP,R&D,new equipment/system,and product meetings.•Develop of Compounding and Packaging Batch records for commercial,stability and R&D products.•Lead/Support R&D, FDA Commitment,and Commercial project plans.•Manage R&D,Commercial and FDA Commitment schedule and project plans.•Creation of Validation program and structure on lean processes.•Supporting and coordinating site QIP program and FDA Commitment to continue with remediation improvement plan.•Coordinate resources for PPQ executions on DEA commercial product PPQ.•Provide extensive expertise on system/equipment troubleshooting and improvement for manufacturing process: Suspension Compounding Process,Packaging Process,Stability,Oral solutions and Powder filling.•Development section project meetings to improve product process validation•

Direct/Manage site Remediation Plan for OTC/Non-OTC consumer drug and cosmetic manufacturing/packaging operations with a multi-formulation capabilities supporting an extensive portfolio of Liquid, Aerosol, Gel and Cream products under Federal Regulations CFR/cGMP's with principal attention to OTC’s formulations. Development and implementation of Quality System adapting functional units and culture to a new regulated operational environment throughout the site based on USA, European/Canada Federal and International regulations requirements.•Direct Plan Management processes/decision making on new culture operational changes and regulations.•Develop of QS logistic to improve operational performance introducing QM Metrics. •Develop a new cost effective Cleaning/Sanitization processes based on a multi-product site. Standardization of the cleaning/sanitization processes for all formulation significantly reducing operational cost. Optimization of resources/production cycles.•Managed project schedule, resources, project status, labor hours, costs, and risk factors to stakeholders. •Develop a site cycle development, policies and Master plans.•Actively providing regulatory guidance to Plant Management and VP's.•Provide technical validation support.•Coordination, coach/approval of plant site assessment/remediation implementation including all change control,SOP’s,and plant site document approvals.•Support QC Laboratory methods,analysis,and operation.•Proficient on optimizing manufacturing processes.•Provide regulatory/compliance expertise on system/equipment troubleshooting for site operation.•Continuously support daily Process,Systems,QA System, Validations, GMP, Laboratory, Management,Controls, manufacturing/packaging site troubleshooting. •Development of site Validation Master Plan,(VMP).•Supporting Customer Audits and leading action plan within Remediation efforts.•Supporting Local/International regulatory forum,representing client at FDA and Customers audit processes.

Direct/Manage Validation Dept under a 483 FDA observation manufacture plant at Curacao Willemstad for intermediate Collagenase. Direct,coordinate Validation/Engineering impact Assessment/Remediation plan managing a multicultural professional group. Manages and applies extensive technical validation/engineering and compliance in the coordination of multiple,complex,routine projects involving the planning, design, modification, construction, maintenance improvement of processes,systems and facilities. Apply advanced technical principles,theories,and concepts proposing new principles/concepts, such as ASTM 2500E. Plan, organize/coordinate work of a staff of scientist/engineers/technicians from Engineering and Validation Department. Lead efforts with manufacturing, process/system improvement, utilities, facilities, labs, and QA. Provide technical validation solutions to a wide range of events. Presenting/defending validation packages execution related to impact assessment/remediation and implementation to Corporate audits/FDA/client legal advisory authorities toward 483 response. Coordination, supervision/approval of plant site assessment/remediation implementation including all change control,SOP’s and plant site document approvals. Coordination and approval of more than sixty validation/engineering operational system/equipment. Proficient on manufacturing processing to leverage collagenase powder process. Provide expertise on system/equipment troubleshooting and improvement for manufacturing/engineer. Completed revision/improvement of VMP satisfying FDA commitment. Approval of extensive equipment/system impact assessment/remediation reports meeting FDA commitment. Review/approval of validation procedure,VMP (Validation Master Plan),program deliverables,quality engineering impact assessment,change controls,change requests,assessments,protocols,reports,deviation/CAPA,(TWise). Provide microbiological principles associated to manufacturing process/systems.

Verification and qualification of Walk-in incubator, liquid N2, chest, ultra-low freezers for master seeds cells & viral storage, stability chambers for cryo viral preservation and DT, industrial refrigeration systems. Documentation development, calibration and programming of data ValProbe loggers, validator 2000, temperature mapping. Data verification and analysis, developing process validation documentation, TC calibration, deviations and observations documentation and Change Control & BMS system management. Applications of regulatory, (ASTM2500) and biotechnology sciences based on US/EU, Canada and Belgium requirements. Validation protocol execution review and technical troubleshooting and engineering support. Design, upgrade and verification of packaging line automation/operation.

Managed four (4) cleaning validation engineers and served as the primary liaison for Intarcia’s management team.• Oversaw and participated in the De novo development of CIP and SIP cleaning cycle processes for a MS-35 Spray Dyer, Sartorius TFF skid, and several stainless steel batch formulation vessels.• Created and managed project schedule and resources.• Managed outside analytical testing service provider for endotoxin, TOC, and microbial enumeration testing requirements.• Regularly communicated project status, labor hours, costs and risk factors to Intarcia stakeholders.• Managed others and directly participated in the development and execution of subsequent qualification protocols and final reports.• Analyzed, reviewed and approved cycle development and qualification data to ensure that robust pre-determined acceptance criteria was developed and that test results met the criteria.• Developed cleaning validation SOPs.• Added value by re-engineering spray dryer design to eliminate dead legs and reduce the number of sampling sites required.• Provided input and guidance for a parallel project associated with a Getinge Autoclave qualification designed to meet EN285 requirements.

Verification and qualification of Walk-in incubator, CO2 and shaker incubators, líquid N2, chest, ultra-low freezers for master seeds cells & viral storage, stability chambers for cryo viral preservation and DT, industrial refrigeration systems. Fogging rooms disinfection process and qualification. BioSealer & BioWelder for media fill tubing. Applicom S.U.B. Dual Bioreactors, CelliGen BLU S.U.B. Bioreactors, Documentation development, calibration and programming of data ValProbe loggers, validator 2000, temperature mapping. Data verification and analysis, developing process validation documentation, TC calibration, deviations and observations documentation and Change Control & BMS system management. Applications of regulatory, (ASTM2500) and biotechnology sciences based on US/EU, Canada and Belgium requirements. Validation protocol execution review and technical troubleshooting and engineering support.

Process Validation of double door cart Autoclaves, supervising support personnel 1st and 2nd shifts. Performing dry goods and liquid runs, data verification and analysis, developing process validation documentation, TC calibration, deviations and observations documentation management. Applications of regulatory and biotechnology sciences based on US/EU, and Canada requirements. Validation protocol execution review and execution and Engineer, technical support.

Support on short-term WFI system project at Los Angeles, CA. Applications of regulatory and biotechnology sciences focused on FDA observations and required changes for the Water for Injection system and controls. Documentation development and execution of WFI cold and hot point of use base on FDA/Lachman 483 observations remediation project. Actively participation in TEVA Project meetings. Implementation of changes following all regulations and product requirements. Development of sampling plan schedule and trainingValidation protocol development and execution QA/QC Engineer, technical support cGMP’s, global regulations and report writing experience.

Lead Commissioning, Qualification and Validation start-up activities at BMS LSCC Central Utility, Lab/Office, Chemical Storage, Manufacturing, Warehouse, Guard Houses and Security facilities. Develop work plans and review execution of Commissioning, Qualification, and Functional Performance Tests at BMS Biotechnology Plant Site start-up. Applications of regulatory and biotechnology sciences focused on FDA regulations and BMS requirements. Actively participation in BMS Project meetings and all project design activities under all pertaining regulations and product requirements. QA/QC Engineer, technical support cGMP’s, global regulations and report writing experience.Reviewing/approving cGMP protocols and reports including commissioning and work-plans Investigating, documenting, and tracking cGMP deviations, change controls, OOS and CAPAsProviding guidance and training to employees to ensure compliance to cGMP's and SOP's

Lead Commissioning, Qualification and Validation start-up activities at BMS LSCC Central Utility, Lab/Office, Chemical Storage, Manufacturing, Warehouse, Guard Houses and Security facilities. Develop work plans and review execution of Commissioning, Qualification, and Functional Performance Tests at BMS Biotechnology Plant Site start-up. Applications of regulatory and biotechnology sciences focused on FDA regulations and BMS requirements. Actively participation in BMS Project meetings and all project design activities under all pertaining regulations and product requirements. QA/QC Engineer, technical support cGMP’s, global regulations and report writing experience.Reviewing/approving cGMP protocols and reports including commissioning and work-plans Investigating, documenting, and tracking cGMP deviations, change controls, OOS and CAPAsProviding guidance and training to employees to ensure compliance to cGMP's and SOP's

Design, qualification, validation and execution of high technology biotechnology equipment for B99 Amgen expansion. Review and execution of Installation Qualification, Functional Performance Tests and Qualification at AMGEN Biotechnology Plant site B99 Research and development Expansion Project Thousand Oaks, CA. Applications of regulatory and biotechnology sciences focused on FDA regulations and AMGEN requirements. Actively participation in B99 Expansion Project meetings and all project design activities under all pertaining regulations and product requirements. Thousand Oaks-Los Angeles, CA

Design, qualification, validation and execution of high technology biotechnology equipment for vials manufacturing using antibody. Commissioned to work with validation team to ensure compliance according to cGMP’s, FDA and Amgen regulations. Development and execution of qualification Protocols, Variance, Summary reports at AMGEN Biotechnology Plant site at Fremont CA, BMX Phase 1 project for Vectebix ™ product. Applications of regulatory and biotechnology sciences focused on FDA regulations and AMGEN requirements. Actively participation in BMX Phase 1 project daily meetings and all project activities under all pertaining regulations and product requirements. Validation documentation designs, development and execution of IQ/OQ/PQ Bioreactors, Purification, Filter Media Stations, Skids, Portable Tanks, Harvest Tanks, Alarms, sequence of operation, interlocks qualification through automate Delta V systems, cold rooms, incubators, in-process filter stations, temperature mapping and cleaning validation methodology/recovery studies.Ensure manufacturing biotechnology equipments qualification standards, process and systems accordingly with federal and state regulations toward validation cGMP’s, including document control, validation records, system drawings, P&ID’s, specifications protocols, summary reports, etc. Ensure Validation/QA training programs.Implementation of process and system improvements, revalidation and commissioning programs. Follow schedules for executions according to the Validation plan.

development of pharmaceutical business accounts, sales and marketing. Introduction of high rated and trained professional resources to new projects such as CSV, CISCO, IT System qualification and validation. Dynamic sales to achieve year goals, project to increase business potential and open new long term projects. Monthly Revenue reports and attends business developed meetings. Dynamic territory business developer. Achievement of 3 new accounts for project development of CSV and Biotechnology implementation. Increase business revenues at 500K in three months.Actively developing Pharmaceutical accounts and business growth. Hiring personnel at project development by a 30% in business increase. Actively participation in Interphex, PR and open new business accounts.

Commissioned to approve and reviews Protocols, Incidents, summary reports and executed protocol revisions at ABBOTT, PR Humira launch with Quality Assurance Technical Assurance Team. Implement Regulatory applications and requirements according to FDA regulations and ABBOTT requirements. Actively participation in project start-up meetings and project activities. Approval and Review of Utilities, Cleaning validation, (raw data, recovery studies and reports), Fermentation and Purification Protocols (IOQ’s) and Commissioning at Abbott-Barceloneta, PRAutoclaves, Incubators, cold rooms, Kaye Validator qualification/validation activities.Incident coaching development to specific area group and their approvalsCAPA, Investigations, PA and CA programsExecution awareness training supporting execution of ProtocolsEnsure Validation resources availability base on Validation Plan Supervise Validation Specialist and Engineers assignments to assure completion of tasks based on validation schedule activities.

Lilly del Caribe Pharmaceutical HUMALOG Project, Carolina, PR.Approval and reviews of Protocols, Incidents, Summary Reports and executed protocol revisions at Lilly del Caribe, PR Quality Assurance Technical Assurance Team. Implement and coaching of Regulatory applications following FDA regulations and Lilly requirements. Actively participation in project start-up meetings and all project activities. Approval/Review of Utilities, Fermentation and Purification Protocols (IOQ’s) and Commissioning at Lilly del Caribe Carolina, PRIncident coaching development to specific area group and their approvalsExecution awareness training supporting execution of ProtocolsRevision of Summary reports and workshop meetings participation.

Consent decree Management of Quality Assurance team responsible for the approvals of Executive Investigation Reports at Schering Plough, Manati, PR Quality Assurance. Technical Assurance Department, CAPA, observations and Quality programs. Regulatory applications and requirements toward Consent Decree and FDA regulations. This investigation report includes a complete analysis of situation to be investigated and the generation of request adequate documentation for a final evaluation for different areas such as Manufacturing, Utilities, Packaging and Content aseptic areas, among others. Address of root and direct causes that impact pharmaceutical products. Implement corrective and prevention actions in order to achieve customer needs accordingly to local and federal regulations. Packaging and Manufacturing areas specialties include solid, blisters, filler, dryer, instruments, labeler, capper, conveyors and final packaging process.

oncent Decree Phase I Validation Engineering. Consultant services on Pharmaceutical and Fine Chemicals and biotechnology. Responsible for IQ/OQ protocol generation, execution, data analysis and final report preparation for processing, cleaning validation studies, (CIP, SIP), and utilities equipment and systems under the local and federal regulations. Responsibilities also include P&ID and system specifications creation, review and updates. Group meetings for new technology implementation based on customer needs.

Marketing and Sale Executive, local and international. Coordinate laboratory operations according to local and federal requirements. Managed and directed the organization toward new technology, based on log-term product and profitability goals. Managed and directed the organization toward its primary objectives based on profit and return on capital. Planned, developed and established policies and objectives of businesses organization in accordance with Board directives and corporation charters. Ensured market competitiveness and organizational excellence.

Planning and organization of Laboratory documentation and systems. Preparation of audit system and implementation of standard operational procedures and guidelines prior to local and federal inspections. Upgrading of laboratory analysis processes and fully training program to resources including sampling technicians. Qualification of methods and laboratory equipment. Quality Assurance of testing and process for water samples. Implementation of metrics for annual statistical evaluations designed for technician, equipment and processes.

Analyzed and improved packaging line processes and documentation. Involved in the HAZOP section and automated transfer line systems. Developed quality and process systems in compliance with FDA and pharmaceutical regulations. Evaluated and revised system design complaint with process quality cGMP’s and FDA regulations. Process and methodology technology transfer from Hoddesdon, UK to Arecibo plant site for Proscar classified cleaned rooms.Controlled PM’s and calibration to avoid non-compliance and maintained good efficiency for equipment and operations. Qualified/Validated the cleaning process and introduced new proposed disinfectant for sanitation adapted to the equipment configuration. Lead, development and execution and/or revision of validation documentation related to the following cleaning processes:Manual WashClean in Place (CIP) process for Formulation EquipmentUltrasonic sinks washersSteam in Place (SIP)Clean-out-of-Place (COP)Tanks (CIP) Cycle OptimizationEstablish residues, recovery, microbial limits, statistical analysisBioreactor, Media/Final Filter stations and product transfer lines cleaning assessmentsProvided coordination with the adapted to the equipment configuration. Provided coordination with the Potable/USP water systems for production.