Hernán Vera (Mba) Email & Phone Number

Kennesaw, Ga, Us

Norcross, Ga

Hold full accountability for direction of seven (7) Operations at Norcross, GA. The role provides direction for all Manufacturing Operations (Molecular Diagnostic operations, transfusion and transplantation diagnostic products, Cell Culture and Blood procurement), Training, Facilities Maintenance, Process Improvements and Technology Transfer. The Senior Director of Manufacturing reporting to the Sr, Vp of Operations and is an active member of the Immucor leadership core team and lead the manufacturing Quality Systems.Achieved product quality improvements and instigated Norcross site operational metrics resulting in enhanced product supply and drove decrease in back orders, reduction in non-conforming scrap and enhanced delivery to customers. Expertly stabilized the organizational structure, improved training programs, and drove decrease in turnover from circa 20% to ≤ 5% resulting in reduced production losses and enhanced compliance. Drove regulatory compliance and enhanced audit readiness resulting in substantially improved audit performance with minimal Operations non-conformances in MDSAP and FDA audits. Enhanced Product supply output and substantially reduced product batch failures by 66%. Drove cGMP compliance with zero audit observations for audits in the last two years. Designed and improved operational systems, Quality system and Manufacturing infrastructure to support consistently high-quality customer service. FDA and other Regulatory auditors recognized the powerful system implemented reducing documentation errors and re-work in 98%. Partnered with the Quality organization ensuring quality standards are met with a “no-compromise” mind. Coached the manufacturing team on critical thinking and structured problem solving. Re-engineering manufacturing operations flattering the organization, reducing waste. Adding automation and redefining positions achieving a cost reduction in headcount of 30% and operation in cost reduction of $1.5 M.

Georgia

Lead of Solid Phase Manufacturing operations. •Ensuring on-time product availability•Maintaining a high level of cGMP and quality compliance•Establishing and delivering direct and indirect cost reduction targets through continuous improvement initiatives•Achieving optimum employee performance, attitudes, and results, changing a new high performance manufacturing culture•Establish a culture of Operational Excellence and create an environment of continuous improvement by driving variability and waste out of manufacturing processes. •Develop productivity and cost reduction targets and metrics that are aligned with corporate objectives and demand. Drive initiatives to achieve these targets

Marietta, Ga

• Oversaw support and development functions for United States products, included technical support for existing and newly acquired products at internal and external manufacturing sites, all United States in-licensed products, and development of line-extension products for United States market.• Recruited to lead transition from a fully virtual company to a fully integrated pharmaceutical company had just acquired. Oversaw functions newly transferred from research group to technical operations included pharmaceutical development, Manufacturing Operation, technology transfer, Scale up and overall activities required to start up a new manufacturing plant starting from zero. •Liaison between Osmotica Buenos Aires (Early Development operations) and Osmotica US. •Built a new Research and Development center in Marietta, GA facilities.•Designed/built labs, and initiated early development facilities in Marietta, Facilities.•Built a team of scientists focused on Advanced Drug Delivery Systems based technologies and products.•Responsible for all Development Reports, Module 2 and 3 and Approval of all technical documentation associated to US operations.•Head of Manufacturing Operations

•Manage a global group of product experts supporting development projects and commercial products. Provide technical support to Solvay Pharmaceuticals’ current marketed products around the world.•Identify and implement potential process improvement projects with minimal regulatory impact to reduce cost, cycle time or improve manufacturability including packaging configurations and packaging facilities.•Lead product transfer and validation activities.•Provide technical expertise in the evaluation of alternate manufacturing and packaging facilities.•Active participation in teams from development to commercialization.•Support the product transfer for US to EU and from EU to US, conducting due diligent as a manufacturing expert and evaluating potential facilities, technologies and products.•Conduct GMP and Regulatory audits as manufacturing expert (including facilities in US and Europe).Implement suitable changes in our products to adjust the process according to the correspondent pharmacopoeia or regulations.

Vega Baja, Puerto Rico

• Re- qualified the manufacturing operations after Regulatory concerns. The plant was re- qualified and certified by the FDA in a period of 18 months. FDA used the new system implemented as a model for other pharmaceuticals.• Developed and implemented continuous improvement concepts in production lines reducing cycle times in 40%, reducing calibration and preventive maintenance execution time in 60%. Implemented continuous monitoring of good lots to prevent deviations and identify trends. Reduced deviations in 80%. Evaluate all the deviations in the manufacturing areas and execute problem-solving analysis following the Kepner Tregoe philosophy. Reduced problem evaluation time in 70% with accurate and reliable results.• Redefined and mapping processes and established flowcharts, implementing six sigma. Promoted shop floor participation in workshops using self-management teams. Several quality processes were improved; Implemented critical process standards and explored benchmarking opportunities to develop processes, which are “best in class.• Divested eight (8) products to outside contractor. Transferred and approved those by the FDA in 12 months. I had the role of lead project manager for the in and out transfers. • As a project manager, I led the transfer of several products from late development to commercial operations including, design of facilities, equipment, utilities, SOP’s , batch records and validation protocols.

Barceloneta, Puerto Rico

•Supervise 4 different manufacturing departments including Solid Dosages, Liquids, Aerosols and Parenteral.• Lead technology transfer from late development to Commercial operations, Product support and Validations

Master Of Business Administration (Mba), Changes In Organizational Behavior And Production, 3.85

Activities and Societies: Approved Thesis in Implementation of Self Management teams in lean Organizations

Bachelor Of Engineering (Be) 4 Years Completed, Electrical And Electronics Engineering

Bachelor Of Applied Science (B.A.Sc.), Biochemistry And Molecular Biology, 4.00

Activities and Societies: President of Pre- Medic club Leader of movement for a better world- (MMM)Graduated Summa Cum Lauder Top ten.

Master Of Business Administration - Mba, Changes In Organizational Behavior And Production