Manager Project

Rafael A. Rios

PO Box *** Trujillo Alto, Puerto Rico 00977 787-***-****

************@*****.***

SR. MANUFACTURING / OPERATIONS MANAGEMENT PROFILE

Results-producing management career spanning 10+ years demonstrating year-

over-year improvements in Quality, Cost and Productivity in the

Pharmaceutical Industry. Decisive operations leader with excellent

analytical, organizational, team building and planning skills. Strong

reputation of commitment & integrity, focused on developing a results-

oriented organizational culture through the deployment of lean six-sigma

and other continuous improvement initiatives. Disciplined manager with

success in leading & challenging cost reduction initiatives, planning and

scheduling, finance & budget management (operations and capital),

personnel administration, process engineering and capital improvements

projects. Ability to handle complex planning and coordination's in a high-

pressure environment. Fully computer literate, including Windows OS,

Microsoft Word, Excel, Power Point, MS Project, Minitab, GxPharma, SAP,

Kronos, TIMS as well as other proprietary applications. Bi-lingual in

English & Spanish, Available for travel and relocation.

PROFESSIONAL STRENGHTS

. Operations Management

. Process Engineering & Redesign

. Aseptic Fill/Lyophilization

. Project Management

. Safety Standards and EH&S

. Lean Six-Sigma Green Belt Certified

. Eng./Production Maintenance

. Cost Containment & Reduction

. Regulatory & Compliance

PROFESSIONAL EXPERIENCE

PFIZER - Carolina, Puerto Rico (2002-2010)

Manager, Production Operations

Manager, Engineering / Production Maintenance

Directed all aspects of the manufacturing operations (formulation,

filling, sanitation, lyophilization, sealing, packaging, production

maintenance and process engineering / improvements). Established

performance indicators (KPI's), operating goals, transformation

initiatives, training plan, coaching and development, productivity

improvements, cost reduction program and capital project management.

Temporarily assumed Director / Leadership PPU responsibilities. Managed

staff of 4-8 direct reports and 100+ indirect reports. Developed and

administered a $12 million operating budget.

ACHIEVEMENTS:

. Led Green Belt Project (Tygacil Yield Improvement), re-designed

process, reduced product waste, improved yield 10.5%, applied DMAIC,

Kaizen workshops and other Lean Six-Sigma methodologies and ideas

generated by cross-functional team (supervisors, engineers, operators

and technicians).

. Restructured and synchronized PPU resources (Tygacil Flexibility

Project); achieved 21% reduction in standard cost, reduced 80% Job

Descriptions, integration to line-profile manufacturing operators /

technicians, achieved cost reduction of $750K in operating costs.

. Led-Couch-Mentor PPU Green Belt Candidates; project scope &

development, DMAIC methodology, Kaizen workshops, Standard Work, 5S,

Lean Six-Sigma tools, Projects update & presentations.

. Reduced 85% equipment mechanical interventions and improved overall

OEE up to 65% by initiating, implementing and managing new PM / PdM

activities.

. Improved First Time Quality; reduced 82% events (MIR's) and 93% in job

performance.

. Zero (0) FDA / MHRA observations (manufacturing & packaging) for the

last two years.

. Secured bottom-line savings of $800K through headcount reduction, by

optimizing manufacturing processes as well as instituting controls and

accountability.

. Drove forward productivity improvement initiatives that allowed

significant efficiencies and cost reduction including but not limited

to: Yield improvements 10.5% and cost savings $2.4M, improved

customer service levels up to 99.7% and schedule adherence 98%,

Reduced; overtime by 50%, cycle time 40% and downtime 85%, mfg.

supplies expenses $600K, batch record errors 80%, manufacturing

documentation simplification (MES) and SOP harmonization, Zero (0)

loss time safety incidents (2006-2009), etc.

. Awards: Three-Time Best Site Project (2009, 2005), Two-time Wyeth

TOP&S Best Practices Global Recognition (2009), Wyeth TOP&S

Presidential Award (2009).

BRISTOL MYERS SQUIBB - Manati, Puerto Rico (2001-2002)

Sr. Supervisor, Manufacturing & Lyophilization

Led and oversaw the effective utilization of people, equipment's and

materials; for safety and discipline, product quality, compliance,

manufacturing efficiency schedules adherence and cost improvement. Manage

the Aseptic Filling & Lyophilization Operations (24 Hrs./ 7 Days

Operation); Lead all Lyophilization and Mfg. Process investigations.

Managed 35 direct reports.

ACHIEVEMENTS:

. Optimized productivity by 15% through development and implementation

of continuous product flow line using lean manufacturing

methodologies.

. Drove forward productivity improvement initiatives that yielded a 20%

in syringe line efficiency.

AMGEN - Juncos, Puerto Rico (1999-2001)

Assoc. Manager, Manufacturing

Managed aseptic filling operations (vials & syringes), assure effective

management and utilization of resources; equipment's and materials;

safety and discipline, product quality, compliance, manufacturing

efficiencies, schedules adherence and cost improvements. Managed 4

direct reports and 60 indirect reports.

ACHIEVEMENTS:

. Implemented process improvements to reduce product waste, improved

yield by 2% for low volume lots and establish inventory controls that

resulted in cost saving of manufacturing supplies ($100K).

. Implemented process and equipment improvements to eliminate product

rejection (particles).

. Outstanding compliance record during FDA / MHRA inspections.

Wyeth-Ayerst Lederle, Carolina, Puerto Rico (1992-1999)

Production Maintenance & Lyophilization Superintendent

Production Supervisor

Extensive supervisory background in overall manufacturing & Packaging

operations (Component Preparation, Aseptic Filling, Sealing,

Lyophilization, Clean Rooms (Class 100) & Sanitation, Visual Inspection

and Packaging Process), management of process engineering / improvements,

production maintenance team and shutdown management. Managed 45 direct

reports (operations & technicians).

ACHIEVEMENTS:

. Led the maintenance re-organization, staffing justification to manage

increased volumes and 24/7 coverage, oversaw process engineering /

improvements of major equipments, repairs and overhaul, production

shutdown, CAL, PM and PdM's. Reduced equipment downtime by 20%; zero

(0) associated events (MIR's) due to equipment malfunctions or

deviations.

. Project Management; Administered PPU Capital improvement Projects;

identified, justified, budgeted, developed, planned, scheduled and

monitored for on-time execution and completion, reduced process

vulnerabilities & gaps.

. Drove forward productivity improvement initiatives to improve step

yields 3-5%, reduced department overtime over 50%, reduced mfg.

supplies expenses > $150K and PPU MIR's reduction > 50%.

. Glass Particle Reduction Team - Project Leader; Awarded Best Practice

Site Project - Carolina Plant & participated TOP&S Global Recognition;

identified /eliminated glass particulate sources, equipment re-

designed and controls implemented, re-established supply domestic /

Japan Market, eliminated product backorders and improved Quality -

eliminated associated events / investigations.

EDUCATION & TRAININGS

MASTER BUSINESS ADMINSTRATION (MBA): University of Phoenix, Guaynabo

Puerto Rico

BACHELOR OF SCIENCE, ELECTRICAL ENGINEERING (BSEE): Polytechnic

University of PR, Hato Rey, Puerto Rico

Black Belt Training completed - Rath & Strong, Maintenance Excellence

Training's; Lyophilization Technology (Lyophilization Theory, Freeze

Dryers Maintenance & Troubleshooting), Mindset & Behaviors, Change

Management and Couching & Development.

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