Sandra Acosta Email & Phone Number

South Plainfield, NJ, US

South Plainfield, New Jersey, US

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.

Reading, Massachusetts, US

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.

New York, New York, US

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.

Basel, CH

• 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.
• 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.

Largo, FL, US

• 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.
• 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.

Lawrenceville, GA, US

• 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.
• 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..
• Managed project schedule, resources, project status, labor hours, costs, and risk factors to stakeholders.
• Develop a site cycle development, policies and Master plans.

Watford, Hertfordshire, GB

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.

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.

• 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.

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.

Dublin, Coolock, IE

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.

Tel-Aviv, IL

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.

Lawrence Township, NJ, US

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.

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.

Thousand Oaks, CA, US

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.

Thousand Oaks, CA, US

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.

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.

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.

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.

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.

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..

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..

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.

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.

Ms, Biology, Industrial Microbiology, Minor In Music & Statistics

High School Diploma