Juan J. Milano
Union City
Summary
Senior manufacturing manager at Thermo Fisher Scientific with expertise in operations reengineering and team development. Increased oligo production by 233% while cutting costs by $350,000 annually. Proficient in lean manufacturing and strategic planning, contributing to substantial revenue growth and enhanced cross-functional collaboration.
Overview
18
18
years of professional experience
Work History
Sr. Manufacturing Manager
ThermoFisher Scientific
Pleasanton
09.2022 - Current
- Oversaw 89 employees and daily operations across four oligonucleotide (Oligo) manufacturing labs: Amp, cRNA, cDNA, and High Throughput (HTP).
- Led a team of 20 production personnel who helped increase Oligo production in the Custom Primers lab from 15,000 Oligos per week to 50,000 per week.
- With support from the cDNA production team, increased weekly revenue by $150,000 by manufacturing additional sales orders without increasing production personnel.
- Successfully reduced operations costs in two production labs by consolidating a seven-day workweek into a five-day workweek for a combined total labor savings of $350,000 annually.
- Developed and implemented cross-training program for production personnel in all four labs, enhancing operational flexibility.
Director of Operations
Biotrace Medical Inc.
Menlo Park
01.2022 - 06.2022
- Managed day-to-day operations, establishing weekly and monthly production schedules to optimize workflow.
- Implemented a Kan-Ban system, which helped improve production efficiencies, and first pass yields increased from 93% to 98%.
- Tempo Pacing Lead build was increased from 450 catheters per month to 700 per month within five months.
- Led cross-functional team, collaborating with quality team to enhance supplier agreement language and strengthen supplier relationships.
- Successfully negotiated the cost of sterilization from $870 per load to $800 per load to reduce the sterilization cost per unit.
External Manufacturing Manager
Roche/Genentech
South San Francisco
09.2019 - 01.2022
- Led team in identifying and evaluating potential contract manufacturers for new device development initiatives.
- Managed domestic and international contract manufacturers to ensure alignment with production goals.
- Oversaw the negotiation of the development contract that reduced the initial device development cost from $45 to $26, saving $19 million over ten years.
- Selected manufacturing site in Bray, Ireland, collaborating with quality and regulatory teams to qualify for drug reconstitution device production.
- Working with our Transofix device supplier, we validated and qualified our existing Transofix reconstruction device and avoided product stock-out.
Director of Manufacturing
Alexza Pharmaceutical
Mountain View
04.2017 - 02.2019
- Led manufacturing production department, overseeing manufacturing engineering and coordination with domestic and international contract manufacturers.
- Coordinated with domestic and international CMOs/vendors to requalify production lines through protocol review, process validation, and production plan approval.
- Worked with our PCBA supplier in Malaysia and successfully requalified the PCBA production line, which enabled the timely delivery of PCBA's Printed Circuit Boards to our contract manufacturer of Upper and Lower housing sub-assemblies in Peach Tree, Georgia.
- Built the production operations team by hiring a manufacturing engineer and technicians to support production builds.
- Collaborated with product managers to develop strategic business plans addressing future product development and production volume increases.
- Oversaw development of medical devices
Director of Manufacturing
Gener8
Sunnyvale
04.2016 - 04.2017
- Managed manufacturing production, printed circuit board test, and cleanroom operations, enhancing product quality and reducing cycle time and costs.
- Improved OTM "On Time Delivery" from 63% in Q1 2016 to 81% in Q2 2016 to 87% in Q3, and 90% in Q4 2016, respectively.
- Implemented an employee training program to help develop and keep production personnel motivated and updated with the latest production techniques.
- Conducted frequent unannounced audits of production documentation and training records, fostering a culture of compliance with operating procedures and regulatory requirements.
- Increased Q2 2016 revenues by 15% from Q1 2016, followed by an additional 12% increase in Q3 2016 revenues.
- Medical Devices & High Technology
Director of Engineering & Production
Bayer Healthcare, formerly Conceptus Inc.
Milpitas
12.2012 - 01.2016
- Led manufacturing engineering department to enhance product quality and decrease cycle time and product cost.
- Managed an annual departmental budget of $8,000,000 with a capital equipment budget of $1,000,000.
- Collaborated with the procurement team, and we were able to negotiate the reduction in the cost of a welded sub-assembly, hypo-tube to the primary coil, used in the ESSURE device from $5.65 per sub-assembly to $4.00 per sub-assembly; cost-saving $1.65 or 29% per sub-assembly also signaled a three-year contract at the new $4.00 price.
- Reduced kit cost purchase price from $137 to $133.7 by implementing a new process with welded sub-assemblies and hypo-tube to primary coil.
- Conducted weekly meetings with contract manufacturers to drive continuous improvement activities and enhance operational effectiveness.
- Managed compliance for Class II medical devices to meet regulatory standards.
Operations Manager
Hansen Medical Inc.
Mountain View
08.2010 - 12.2012
- Successfully implemented single-piece flow manufacturing, reduced catheter build time from 12.5 hours to 8.7 hours, thus improving production throughput.
- Improved the manufacturing production throughput of Coagulation and sizing catheters from 6 catheters in a 450-minute shift to 24 catheters in the same 450-minute shift.
- Improved catheter first pass yields from 65% to 98% within nine months.
- Facilitated launch of two new products by developing process flow and coordinating IQ/OQ of production equipment and PQ/PPQ build.
- Led manufacturing production operations overseeing 22 direct reports to achieve operational goals.
- Class II & III Medical Devices
Sustaining/Manufacturing Engineer
Apieron Inc.
Menlo Park
02.2009 - 06.2009
- Supported the manufacturing production line daily by monitoring process yields, product throughput, fixture maintenance, and calibration.
- Identified air leaks and implemented new component changes to improve the manufacturing process of assembling QC field test kits.
- Performed daily NO "Nitric Oxide" 150ppb tank qualification while checking for contamination and provided the production manager with the results, which allowed the production department to use the tank.
- Verified sample filter final product test results using statistics program, releasing the product into finished goods based on findings.
- Class II Medical Device
Senior Manufacturing Engineering Manager
Medtronic, formerly Ablation Frontiers
Carlsbad
01.2008 - 10.2008
- Led manufacturing engineering department, enhancing product quality and reducing costs through targeted improvements.
- Transferred manufacturing processes from R&D into Production, achieving first-time yields of no less than 90%.
- Successfully reduced inline catheter electrical failures by 15% (shorts, opens) by working with manufacturing engineers to develop, validate, and qualify a new Bi-filer wire insulation coating process.
- Hired and built manufacturing engineering department, overseeing seven direct reports including two tool design engineers, two manufacturing engineers, one technician, and two consultants.
- Collaborated with research and development engineers and physicians to develop and launch a new atrial fibrillation therapeutic catheter.
- Developed Class II medical device specifications.
Education
Master of Business Administration -
California Miramar University
San Diego, CaliforniaBA - Physics, Laser Optics
San José State University
San José, CaliforniaSkills
- Supply chain management
- Lean manufacturing
- Six Sigma
- Process reengineering
- Project scheduling
- Budget Planning
- Product introduction
- Assembly line production
- Mathematical reasoning aptitude
- Problem-solving
- Strategic thinker
- Team Building
- Mentoring
- Leadership
- Assembly line production
Languages
Spanish
Native/ Bilingual
Timeline
Sr. Manufacturing Manager
ThermoFisher Scientific
09.2022 - Current
Director of Operations
Biotrace Medical Inc.
01.2022 - 06.2022
External Manufacturing Manager
Roche/Genentech
09.2019 - 01.2022
Director of Manufacturing
Alexza Pharmaceutical
04.2017 - 02.2019
Director of Manufacturing
Gener8
04.2016 - 04.2017
Director of Engineering & Production
Bayer Healthcare, formerly Conceptus Inc.
12.2012 - 01.2016
Operations Manager
Hansen Medical Inc.
08.2010 - 12.2012
Sustaining/Manufacturing Engineer
Apieron Inc.
02.2009 - 06.2009
Senior Manufacturing Engineering Manager
Medtronic, formerly Ablation Frontiers
01.2008 - 10.2008
Master of Business Administration -
California Miramar University
BA - Physics, Laser Optics
San José State University