Supply Chain Human Resources
Resume:
MANUFACTURING PROCESS OPERATIONS
EXPERIENCE Therasage, LLC Boca Raton, Florida
Operations Leadership – Contract Assignment June 2023 – Present Operational leadership with strategic and tactical guidance for the quality, operations, manufacturing, facilities and equipment, engineering, research and development, logistics, supply chain, human resources, construction, and EHS (environmental, health and safety) operational units. HACCP certified. Objectives:
Operations: Development of team members (2 staff) and front-line associates (15 operators); institute daily and quarterly metrics (KPI’s); inter-department meetings; one-on-ones to foster better communication; Streamlined operations through Lean Six Sigma Black Belt principles, SPC, the QMS creation, leveraging, and training; defining a vision and strategic objectives that aligns with the customer, operations, and business strategies. Supported double digit growth which included off shift and extended operational assignments.
Coordinated 3,000-unit refurbishment, achieving $1.44M savings, stable workforce, optimized cash flow
Quality: Assess cGMP, cGDP, FDA (21 CFR 820 and 21 CFR Parts 110, 111, 117) and ISO (9000, 13485) compliance position, to promote quality standards, business excellence, and achieve FDA audit readiness; creating metrics (KPI’s) to track quality performance to support double digit quarterly growth. New product introductions coordinator.
Engineering: New product validation and Project Manager/Coordinator.
Logistics and Supply Chain: Organizational planning and strategy development; DOT, IATA, and IMDB Hazmat Shipping Certification to gain strategic advantages on new product integration; Supported 3PL initiatives and establish logistic KPIs.
Trainer and training coordinator for OSHA, NIOSH, Cal/Osha, and EHS compliance. Enviromedica, LLC Austin, Texas
Plant Manager June 2020 – May 2023
Accountable for all aspects of plant performance; utilized continuous quality improvement strategies; ensured that objectives were met in a cost-effective manner; responsible for safety, productivity, continuous improvement, and employee engagement. Accomplishments include:
Operations: Development of team members (4 staff) and front-line associates (17 operators) to be exceptional players by training and communicating a vision and strategic objectives that aligns with the customer, operations, and business strategy; defined and established clear objectives and expectations, providing direct feedback routinely for performance management and actively engaged in team development and advancement while effectively using prioritization mechanisms to utilize resources across teams to complete required workload to leverage financial acumen in manufacturing and apply knowledge to daily manufacturing operations, prepared capital requests, pro forma cost understanding, and absorption improvement. Planned and managed deployment budgets, schedules, and key operating metrics. Supported double digit growth which included off shift and extended operational assignments.
Quality: Supported cGMP, cGDP, FDA (21 CFR 710, 21 CFR Parts 110, 111, and 117) and ISO 22716:2007 registration compliance, to subsequently promote and maintain quality standards (QMS) and achieve FDA audit readiness through internal audits, documentation support, and process reviews; interim Quality Manager during six-month transition. Created metrics (KPI’s) to track quality performance. New product introductions coordinator.
Equipment: Project Manager with oversight and direct engineering/maintenance support for new equipment installation, verification, and the validation of production processes and equipment in compliance with external and internal requirements (FAT; URS/DQ/IQ/OQ/PQ/Validation).
Shipping and Supply Chain: Contributed to organizational planning and strategy development. ICU Medical Austin, Texas
Project Manager – Contract Assignment April 2019 – April 2020 Managed the workflows and approvals for 4 direct reports; created curriculum and training materials and the integration of this training to 1500 employees in support of the migration from a paper batch record system to an electronic system for this pharmaceutical company, compliant with (cGMP) 21 CFR Parts 210, 211, 820, and 11. Coordinated the development of complete quality documentation for assigned projects related to training and document control. Facilitated the reduction of 120 batch records to 50; streamlined the CAPA commitments to match a compliant batch record; worked with cross functional integration teams; supported activity updates. Project schedule completed successfully and on time. Charlotte’s Web Botanicals, Inc. Boulder, Colorado Plant Operations Leadership April 2018 - December 2018 Operational leadership with strategic and tactical guidance for the quality, operations, manufacturing, facilities E. MARK FERNÁNDEZ
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and equipment, engineering, research and development, logistics, supply chain, construction, and EHS
(environmental, health and safety) operational units to assist in successfully taking the company public in May of 2018. Accomplishments include:
Operations: Instituted daily production metrics, inter-department meetings, one-on-ones to facilitate better communication, a corporate casual dress code and a drug policy for accidents was drafted through legal, product security was improved, training of ten employees with lean six sigma principles, facilitated a merit increase process that included annual reviews where none existed before, created parity with employee compensation to above industry standards, rolled out a multi-tiered employee job level system for employee advancement that included merit targets and cost of living adjustments (for quality, engineering, maintenance, manufacturing and logistics/supply chain), facilitated the construction programs for a new corporate office space and a new manufacturing facility.
Quality: Engaged a third-party auditor to assess our DSHEA, FDA (21 CFR Parts 110, 111, and 117) compliance position, and subsequently, achieving FDA audit readiness through an internal audit compliance unit and through instituting industry-recognized cGMP training. Creating metrics to track quality performance and simplifying the Master Manufacturing Record and the Batch Production Record to reduce errors and improve product cycle time for finished products in quality.
Manufacturing: Qualified four contract manufactures to support the demand of finished products and met the desired company direction of decreasing internal-finished product manufacturing, decreased full time employees by 50% and backfilled with 50% temporary employees, with the anticipation of contract manufacturing filling the manufacturing needs, for less employees in four months-time.
Conceptualized and established Boulder Distribution, a strategic 3PL subsidiary, reducing shipping cycle times from 15 to 3 days through innovative hub placement in Texas and Colorado, enabling achievement of $60M annual revenue target in support of strategic IPO initiatives, delivering results within 3 months Premier Research Labs Austin, Texas
Director of Plant Operations June 2013- March 2018 Executive leadership and oversight of the safety, regulatory compliance, efficiency, and profitability of manufacturing and plant operations:
Established process metrics and KPI’s; supported FDA and customer audits; implemented manager and production associate cross-training requirements; negotiated contracts; Contract Manufacturer Coordinator; New (non-GMP) Product Sourcing Manager.
Improved manufacturing and production yields through SPC techniques, Kaizens, and the application of Lean Six Sigma Manufacturing concepts.
Directed key projects to improve company profitability (shipping/fulfillment hours expanded to 0600 -1900 with no overtime, ERP efficiency at the ship-stage from 90 seconds per scan to 10 seconds per scan, new AF-200 high speed encapsulator - $50k savings with $0.50/thousand capsules repayment plan, capsule inspection table - $10k savings, in- house color label printing process - $0.07/label, bright stock bottle encoding – $20k savings, wide-mouth bottle packaging improvement $0.135/bottle from $0.189/bottle, new roof and solar panels - $1 MM installation savings with a % kwh reduction - $5k/month HVAC cooling cost reduction, 50% bottles per minute output-increase in capsule packaging, and a plant-wide manufacturing capacity improvement of 40%).
Facilitated safety program improvements (HAZWOPER, CPR, AED, and the first responder team).
Supported R&D and integration support for new products to manufacturing.
Led teams for FATs and URS/DQ/IQ/OQ/PQ/Validation. Facility/Maintenance Manager January 2010-June 2013 Supervisory management for maintenance personnel (4 direct reports) with functional ownership of the nutraceutical manufacturing facilities and equipment:
Facilitated equipment and process improvements; improved equipment and process reliability and repeatability; increased process capacity and capability in critical manufacturing areas; introduced new equipment through lean process characterizations; Supported and introduced 5S initiatives; Audited areas for process validation.
Maintained cGMP related documents; supported new customer requests; supported facility expansion and new building designs; managed facility, equipment, and maintenance departmental budgets.
Management oversight of building refurb and installation of a new 10,000-gallon stainless steel, dual-walled tank
Reduced energy costs from $0.115/kwh to $0.055/kwh over a 5-year period. Fernández Engineering Consulting San Marcos, Texas Quality Engineer January 2009-Present
Support ISAT, SSQA, ISO-9000, and cGMP, cGDP, and FDA (21CFR111 & 117) recertification efforts.
Administer CAPA support in an ISO-9000 series and cGMP/cGDP environment; process mapping; quality concepts trainer; developed and conducted experiments (DOE) to support the development and introduction of SPC methodologies; audited areas for process and equipment validation (including USR, DQ, IQ, OQ, PQ); created a QMS for a cGMP/cGDP environment; supported an e-commerce platform; monitored SEO metrics; production management support. Advanced Integration Technologies Pflugerville, Texas Senior Quality Engineer July 2007- January 2009
Developed and conducted experiments (DOE) to support the development and introduction of SPC; created and facilitated quality related training (GTAW, GD&T, and SPC); wrote procedures in support of the ISAT, SSQA, and ISO-9000 initiatives; facilitated internal and external customer/supplier audits in accordance to and in preparation/completion of ISAT, SSQA, and ISO-9000.
Customer quality interface; provided guidance and leadership; process, facility, and equipment engineering, support; CMM Metrology tool owner.
Saved the company $50K/year on energy costs through contract negotiations. DuPont Photomasks, Inc. Round Rock, Texas
Senior Laser Lithography Engineer January 2002 – December 2002
Provided leadership, training, and technical assistance in support areas, including the Lithography process
(laser and e-beam); Metrology (registration and critical dimensions); Binary and Phased Shift Mask
(including KLA Inspection and Repair; Clean and Pellicle); Engineering interface with manufacturing and support areas (internal and external customers).
Improved yields through SPC techniques; supported, defined, documented (ISO/QS 9000), maintained, and improved manufacturing process for existing and/or new reticle product types in laser lithography write areas; utilized SPC techniques to facilitate yield improvements; led a team of engineers in improving line width control by 50%.
Lithography Team Leader, Yield Enhancement FEOL Group Leader January 2000 – January 2002 E-Beam Engineer - Lithography Group Leader July 1989 – January 2000 Supervisory management and leadership for personnel (12 direct reports) and processes of the following fab engineering components, and installed several multi-million-dollar tools:
Lithography write (ALTA 3700/CORE 2564 laser and MEBES/JEOL e-beam) and service contract administrator; lithography process (laser and e-beam); metrology (registration and critical dimensions); phased shift mask (including KLA inspection and repair; clean and pellicle); engineering interface with manufacturing and support areas.
Spearheaded the engineering team effort for QS 9000 quality certification and oversaw the implementation of key company software programs.
Installed first MEBES 4700 in the photomask industry; supported, defined, documented (ISO 9000), maintained, and improved manufacturing process for existing and/or new product types in e-beam and laser write areas. SKILLS MS Office Suite, Visio, SPC, JMP, UNIX, C, Fortran, Pascal, RDOS; Certified – Lean Six Sigma Black Belt, 5S, 8D, PFMEA, Kaizens; PMP (35 PDUs), HCCP, cGMP, continuous improvement principles, lean manufacturing, focus groups, quality teams, continuous flow manufacturing, Total Quality Management, ISO-QS 9000 series, re-engineering, technical report writing, budget development and analysis, cost/benefit analysis, yield/loss reduction, contract negotiation, network marketing, negotiation, conflict resolution, mediation, public speaking; internal/external quality auditor; Master Naturalist, Certificate in Occupational Health and Safety. EDUCATION 2007 Texas State University-San Marcos San Marcos, Texas Master’s in Education, Curriculum and Instruction
2006 Texas State Board for Education Certification Texas Mathematics 8-12 1989 Southwest Texas State University San Marcos, Texas B.A., Mathematics and Spanish Dean’s List School of Science Academic Award PUBLICATION
AWARDS,
HONOR,
COMMUNITY
Ibsen, K., Harris, M., & Fernández, M. (2002). Photomask pattern generation strategies. Microlithography World, 11(2): 10-14.
Maskwriters Users Group Symposium Chair; Recipient of five Accomplishment Awards. San Marcos High School (SMCISD), San Marcos, Texas, Math Teacher, 2003 - 2007. Akins High School (Austin ISD), Austin, Texas, Math Teacher, 2009-2010. Facilitated high school math curriculum.
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