An extensive background in technical roles, project management and leadership positions in the life science industry has yielded an effective combination of value creation, collaboration, agility & technical expertise enabling diverse teams to achieve their full potential and deliver the best solutions for stakeholders, customers and patients.
Overview
24
24
years of professional experience
Work History
Head Project Mgmt. & Eng, Pharma & Consumer Health
Bayer U.S. LLC
07.2019 - Current
Directly responsible for Bayer’s project management professionals and cross-functional teams to successfully lead and deliver large investment projects for the Pharmaceutical & Consumer Health Divisions in the U.S. and Latin America. Manage a portfolio of capital investment projects from conceptual design through construction, commissioning & qualification (C&Q) with average annual spend of $250 Mio/year
Work closely with Bayer's Venture Management to evaluate and define capabilities, facilities and new technology needed in support of long-term business strategy. Support Investment & Capital Portfolio Management in the prioritization and dynamic steering of the programs/projects that are needed to bring products to patients.
Leadership role in scope development, safety, quality, budget, schedule, team formation, project execution, new ways of working, etc… to achieve best business value for Bayer.
Notable projects include new lab space for Bayer Research & Innovation Center and for Bayer’s Bluerock Research (cell & gene therapy) in Cambridge, new Cell Culture Technology Center (mAbs) & new Cell Therapy Facility in Berkeley, greenfield manufacturing site for Women’s Health products in Costa Rica, new OTC Packaging Facility and Distribution Center in Myerstown, new Sterile Fill Facility in Mexico, and numerous cGMP facility/equipment upgrades in the region.
Technical Program Manager - Capacity Expansion Biologics (CEB)
Bayer AG
01.2014 - 06.2019
The CEB program was an expansion of Bayer's production capacities outside of Berkeley, CA for its recombinant Factor VIII (rFVIII) products by building a second manufacturing location at the sites in Wuppertal and Leverkusen, Germany. Program investment was $1.0 Billion
Role involved leading a diverse, international team to successfully deliver complex initiatives against an aggressive schedule and budget. New facilities were designed, built, commissioned and qualified for rFVIII production which included a new Distribution Center, Quality Lab Building, Active Pharmaceutical Ingredient (API) Facility, Sterile Filling Facility (SFF) & Packaging
Responsibilities included: a) Leading, managing and developing Project Managers and Engineering/Technical Leads, b) Developing program budget, schedule and execution strategy, c) Delivery of program goals by priority: safety, quality, schedule and cost, d) Representation of program towards Steering Committee and Stakeholders, e) Efficiency, optimization and risk management within the projects f) Coordination and alignment of procedures and practices between the projects and the sites.
Responsible for successful execution of Bayer Healthcare’s major capital investment projects in U.S.A.
Developed Project Managers & Project Engineers into high-performing teams by providing mentorship, guidance, and opportunities for professional growth.
Enhanced team collaboration through regular communication, goal setting, and performance evaluations.
Major projects included: Brownfield retrofit of API plant for commercial launch of two new rFVIII products, New vial primary & secondary packaging line, Container Closure Device Launch, New QC lab fit-out (all in Berkeley, CA), Vitamin Tablet Expansion (Myerstown, PA), new BHC Headquarters Office Facility (Whippany, NJ), Siemen’s Diagnostic Facility Expansion (Walpole, MA).
Project Manager, Sterile Fill Facility
Bayer Business & Technology Services, LLC
01.2004 - 01.2007
Project Manager for new Sterile Filling Facility ($94 mio) from mechanical completion through qualification & licensure.
Led cross functional team of engineers, maintenance, process owners, C&Q experts, Quality & Suppliers to successfully complete project and achieve EU & FDA approval.
Responsibilities included execution completion, safety, quality, budget, schedule, leadership and oversight of engineering disciplines.
Facility & process design included bulking/formulation, aseptic filling, freeze dryers with auto load/unload system, Bio-Set capping, aluminum over-sealing, tray loading, parts washer, sterilizers, stopper dryer, VHP material pass through, CIP/SIP, ABB DCS, HVAC & WFI/clean media systems.
Principal Engineer Sterile Fill Facility
Bayer Business & Technology Services, LLC
02.2000 - 01.2004
Project engineering lead for aseptic Fill Line, Freeze Dryers, Auto-load System, Container Closure equipment, CIP/SIP and environmental monitoring for above mentioned SFF Project
Prepared user requirement specifications, pre-qualified vendors, supported procurement & contract negotiations, vendor oversight during design/fabrication and installation, prepared documents & led execution for FAT, SAT and IOQ.
Education
Bachelor of Science - Mechanical Engineering
Purdue University
West Lafayette, IN
Skills
Collaboration & Team building
Customer Orientation
Problem-Solving with Can-do-attitude
Active Listening & Strong Communication
Calm Under Pressure
Relatively Fast, Agile and Flexible
Interpersonal Savvy
Enterprise Value Creation
References
Available upon request
Timeline
Head Project Mgmt. & Eng, Pharma & Consumer Health
Bayer U.S. LLC
07.2019 - Current
Technical Program Manager - Capacity Expansion Biologics (CEB)
Carlos Roberto Mira PadillaCarlos Roberto Mira Padilla
Director Regional OE, Projects, Digitalization and Warehouse and Transportation Americas at Bayer U.S. LLCDirector Regional OE, Projects, Digitalization and Warehouse and Transportation Americas at Bayer U.S. LLC
Safety Technician/Administrative Assistant at Bayer Research And Development Services LLCSafety Technician/Administrative Assistant at Bayer Research And Development Services LLC