Manager, Materials and Inventory Logistics Management

SEAN M RAZMI

760-***-**** adb7cf@r.postjobfree.com

Carlsbad, CA 92011 www.linkedin.com/in/sean-razmi

Materials Manager/Quality Assurance (QA) with experience in Quality Systems related capacity, Manufacturing, Product Development and Logistics such as Medical Device manufacturing, Diagnostics, Pharmaceutical and Government civilian sectors. Worked closely with compliance and quality system activities such as:

• Corrective action and Preventive action (CAPA) Process

• Supply planning, Inventory/Forecast Management and shipping

• Knowledge of ERP/MRP and MPS systems

• Contract Administration and Technical and administrative audit on contractor performance

• Post-Market product Surveillance

• DMAIC, Process Improvement and Statistical (EWMA, Pareto) & Risk Analysis

• Internal/external audit support (FDA, TJC and NAVSEA)

• Knowledge, experience and training in GMP and ISO 13485, 14971 & 9001

• Green Belt Six Sigma and Contracting Officer Representative (COR) certifications EXPERIENCE

HALOZYME THERAPEUTICS, INC., San Diego, CA. 09/2016 to 12/2019 Manager, Materials and Inventory Logistics Management; Product Development

• Managed critical reagents (e.g. Hyaluronate powder (HA), HSA) supply/demand activity through timely procurement, continuous inventory tracking and monitoring and securing material availability and cost reduction

• Responsible for identification and selection of new second source vendors for critical reagents and assisted QA in vendor audit and qualification and managed vendor relationships

• Designed, developed and managed critical reagents and GMP standards Forecasting (Adjusting safety stock, reorder point and improving lead time demand) for Product Development, CMO, CRO and Partners and delivered forecast reports (Scorecards/Dashboards)

• As the contract liaison, partnered with contract owners and the Legal team to fulfill Product Development and Regulatory Affairs Contract Lifecycle Management (Apttus & Docusign) activities such as handling CDA/MSA, consultant, service agreements and new supplier work orders or proposals/quotations and responsible for issuing and handling requisitions and managing delivery of purchase orders to vendors or suppliers

• Responsible for all inbound and outbound shipments for critical reagents, standards and samples and collaborated with logistics and shipping/receiving teams to ensure adherence to chain of custody and cold chain processes; Worked with Finance to establish proper ship costing

• Partnered with Quality Control, Bio-Analytical groups and Alliance teams to fulfill critical reagents and standards continuity of supply and replenishment at CMO, CRO and Partner sites

• Managed all in-house material and sample inquiry logistics including handling, storage, stock readiness, dispensing and responsible for material inventory management activities (maintaining an organized inventory and adequate QOH of reagents, presenting KPI scorecards and metrics, generating inventory audit and status reports and dashboards) and oversaw Electronic inventory system (FreezerPro) operation, training and maintenance such as software upgrades, module version updates and created in-house operation mini guide for a high SKU lab

• Responsible for issuance of purchase order requisitions to procure all critical reagents and lab freezer units and storage accessories (ReQlogic)

• Worked with CMC and QA on review and approval of the CMO client disposition and transfer request records for release and inbound shipment of GMP drug substances and upstream and downstream retains and assisted Analytical team in review/selection and coordination of shipment of CMO in-process returns, Engineering runs or client downstream samples and responsible for follow through

• Designed, developed and managed domestic and international GMP/non-GMP material and reagent requests and receipts processes and procedures (SharePoint), responsible for process training, track/trend analysis and authored SOP and the form work instructions (Veeva Vault)

• Led 8 cross-functional team members in mentoring the ONE-TEAM norms and concepts

(SPAWAR) Space and Naval Warfare Systems Command, San Diego, CA. 04/2014 to 09/2016 Lead, Quality Assurance Specialist

• Fulfilled QA oversight on prime contractor’s three Engineers and four Technicians for Fleet Modernization and Installation projects.

• Performed Supplier assurance (e.g. Software, hardware and Fiber optics cable).

• Participated in internal SPAWAR and external NAVSEA audits.

• Reviewed contractor’s QA workbooks and approved Test and Inspection plans and production/Installation drawings.

• Ensured contractor adherence to contract requirements, ISO 9001 guidelines, NAVSEA Standard Items and Afloat installation requirements.

• Responsible for the CAPA process.

• Completed Supplier Installation Performance Assessment review and generated KPI scorecards

NAVAL MEDICAL CENTER, San Diego, CA. 05/2010 to 04/2014 Supervisor, Quality Assurance

• Supervised three QA Specialists. Performed QA oversight on maintenance and services of two prime contractors for six healthcare buildings and 17 clinics. Developed and oversaw Quality Assurance Surveillance plan.

• Developed direct reports’ performance scorecards.

• As a COR, accepted products/technical services, and authorized delivery and procurement of equipment or services with a budget of $6M on behalf of US Government and approved payment and signed applicable contracting documents including invoices for compliance with the contract; Submitted performance reports (CPARS); Provided technical feedback with respect to contract specification and SOW and PWS and maintained a file of all correspondences & documentations

• Utilized Lean Six Sigma methodology to present new QA program and process improvements at 2011 NMCSD Continuous Process Improvement (CPI) poster fair

• Performed COR duties for contract execution and reported results on contractor performance.

• Ensured contractor adherence to ISO 9001 guidelines, NFPA, OSHA requirements.

• Developed contractor performance Dashboard (Pareto charts) for management review.

• Managed a budget of $9M/year for Facility systems Preventative Maintenance and Corrective Maintenance services and approved invoice payments.

• Responsible for the CAPA process

• Interfaced with The Joint Commission investigator during on-site audit.

• Developed an Asbestos and Lead Verification and Testing process for Environmental Group and Beautification project workflow for Facility Managers.

ABBOTT VASCULAR, Temecula, CA. 07/2005 to 05/2010

Lead Product Performance Engineer (PPE)

• Led three Engineers, two Technicians and a Data specialist and responsible for Post-market surveillance (Complaint Investigation) activity on Carotid products, PPE-related HHA and CAPA

• Performed Failure analysis investigation and adhered to GLP guidelines.

• Interfaced with other QS entities during NCMR and Corrective action board meetings.

• Performed Trend (EWMA), SPC and Risk Analysis.

• Participated in Supplier qualification activities.

• Responsible for Adherence to MDR, Vigilance, ISO 13485, cGMP and ISO 14971 requirements

• Participated in FMEA data updates.

• Supported external and on-site audits in relation to all Product Performance activities

• Participated in testing and validating PEH database.

• Responsible for off-site Training of Sales & Marketing in PPE activity.

• Supported authoring Product Performance Engineering Audit process procedure and complaint data request handling document.

ADDITIONAL RELEVANT EXPERIENCE

NICHOLS INSTITUTE DIAGNOSTICS, San Clemente, CA.

Manager, Technical Services, 08/2004 to 07/2005

VIVASCIENCE, Inc., Carlsbad, CA.

Technical Support Specialist, 03/2002 to 08/2004

THE SALK INSTITUTE., La Jolla, CA.

Post-doctoral Scientist, 06/2000 to 03/2002

UNIVERSITY OF CALIFORNIA, Irvine, Environmental Toxicology., Irvine, CA. Post-doctoral Researcher, 05/1999 to 06/2000

EDUCATION

Doctorate in Pharmacology (Ph.D.)

Meharry Medical College, Nashville, TN

Bachelor of Science (BS), Chemical Engineering

The Ohio State University, Columbus, OH

PROFESSIONAL TRAINING

GMP Auditor Training, 11-18

Building One-Team, 03-18

The Presentation Lab, 04-17

7 Habits of Highly Effective People (3 Days), 04-15 ISO 9001:2008 Internal Audit (8hrs), 11-14

Welding QA Inspection Training (2 Days), 06-14

Cabling and Cableway QA inspection Training (3 Days), 05-14 Contracting Officer Representative, 03-12 (5 Days) Civilian Personnel Management Academy (4 Days), 03-11 Service Contract Performance Assessment Training (NAVFAC, 2 Days), 02-11 PQM101 Production, Quality and Manufacturing Fundamentals, 10 Days, 10-10 ACQ101 Fundamentals of Systems Acquisition Management, 17 Days, 10-10 Coaching and Feedback, 07-09

Crucial Conversation for Managers, 05-09

Situational Leadership, 03-09

CAPA Investigator Certification, 4hrs, 02-09

CAPA Investigation Process (Rubric), 3days, 12-08

cGMP Basic, 11-08

Six Sigma Green Belt Training, Quest Diagnostics, 05-05 ISO EN 13485:2003 elements and eight management principals, 02-05

PROFESSIONAL CERTIFICATES

Greenbelt Six Sigma, 2005; Contracting Officer Representative, 2012 PROFESSIONAL RATINGS, AWARDS, AND RECOGNITIONS

Star Awards “Going Above and Beyond”, 09-2019 & “We Respect and Value the Team”, 05-2017, Halozyme, Inc.; 2003 Employee of the year, Vivascience, Inc, 01-04

ABSTRACTS, PUBLIC PRESENTATIONS and OTHER INFORMATION

Available upon request

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