Manager Project

Roland D. Alaniz

**** ******* **. #*****

San Antonio, Texas 78240

Home: 210-***-**** Cell: 210-***-****

E-mail: ************@*****.***

**/**** - */****: Oxford Consultant at:

(Teva Project)

o Revising Existing Procedures

o Developing New Procedures and Work Instructions

(Guthy-Renker Project)

o Addressing and accessing complaints

(Novartis Project)

o Change Controls, unplanned deviations, customer complaints

(JHP Project)

o Reviewing Work Orders for Quality Impact & Identifying

Potential Quality Gaps in the System

11/2010 - 10/2011: Origen Biomedical

Mfg Supervisor - Medical Device Mfg.

. Run day to day 2 shift operations

. Manage 22 (2 shifts) employees

6/2009 - 8/19/2010: Signature Science Inc.

Project #1) Hands-on Petro-Chemical Pilot Plant Operations converting gases

to liquid hydrocarbon fuel.

Project #2) Hands-on Petro-Chemical Pilot Plant Operations converting Shale

Crude to Diesel/Jet Fuel.

Project #3) Hands-on Chemical Pilot Plant Operations converting Canola Oil

to heating intermediary.

2006-2008: Genentech Inc., Oceanside California

Manufacturing Manager (10/30/2006 - 4/15/2008) --- Product Avastin

Operations Manager overseeing the buffer preparation department at

Genentech's Oceanside manufacturing facility.

. Managed an organization of 4 Supervisors and 24 indirect reports

. Initiated manufacturing process and manpower optimization projects (Lean

Mfg, charting, metrics & KPIs)

. Document Owner and / or approver for SOP's, Batch Records, Change

Controls, CAPAs, Validation Protocols, investigations, etc.

. Regulatory Inspections: FDA, EMEA, Internal Corporate Audits, etc

. Quality Systems: Investigations, CAPAs, change controls, materials

management, electronic batch records, etc.

. Performance Management: Hiring, Coaching, Goal Setting, Development

Plans, Calibrations, etc.

. Tech Transfer team to transfer Rituxin product to Oceanside CA facility

for multi-product processes.

o Identifying process SOPs required

o Identifying procedures constant for 2 processes

o Identifying and Eliminating gaps in product transfer requirements

2002 - 2006: Amgen Inc. West Greenwich, Rhode Island.

Manufacturing Manager (6/1/2003 - 10/30/2006) --- Product Enbrel

Area Manager for the buffer preparation and equipment prep department at

Amgen's BioNext facility.

. Managed an organization of 5 Supervisors and 27 indirect reports

. Document Owner and approver for SOP's, Batch Records, investigations,

etc.

. Regulatory Inspections: FDA, EMEA, Internal Corporate Audits, etc

. Quality Systems: Investigations, CAPA, change control, materials

management, etc.

. Facility start-up that included:

. Facility Design: detailed design, equipment procurement, and

acceptance testing

. Commissioning Team Lead overseeing the buffer prep area (22 Tanks up

to 20,000L in size)

. Commissioning team made up of cross functional groups comprised of

manufacturing, engineering, and contract staff to support the

commissioning and validation of the area.

. Manufacturing process scale-up and optimization

. Project timeline tracking

Sr. Manufacturing Supervisor (4/22/2002 - 6/1/ 2003)

Manufacturing supervisor over 8 associates at Amgen's BioNow facility.

. Shift supervision oversight of the Media, Buffer, Dispensing and prep

operations.

. Aseptic media fills (Class 100) under laminar hood

. Performance Management (hiring, goal setting, development, reviews, etc.)

. Quality Systems (Investigations, CAPA, change control, materials

management, etc.)

. Interact regularly with management, engineering, PD, facilities, QA / QA,

etc.

1974 - 2002: Hoechst Celanese Inc., Bishop Texas

API Pharmaceutical manufacturing company.

Team Lead (1/22/2001 - 2/2/2002)

After return from off-shore assignment, managed the facility

logistics center.

. Established parameters for SAP R-3 system for warehousing

and logistics

. Set up automatic reorder systems based on inventories

. Worked with outside contractors on rail-car and land transit

shipments

. Supervised 20 contract warehouse staff for all phases of

warehouse operations that included:

Shipping, Receiving, Materials Management, Packaging,

Purchasing, etc.

Training Manager: Esters Singapore Project (1/1/1999-1/22/2001)

Full ex-patriot assignment in Singapore to provide training and process

tech transfer to a new off-shore manufacturing facility.

. Developed training and certification criteria for Singaporean Nationals

in the US and the Singaporean Government

. Managed 4 associates at 2 separate sites

. Developed the training curriculum, SOPs and training programs in the US

and Singapore

. Participated as a classroom instructor in the Texas Bay City and Pampa

plant sites

. Participated as a classroom and field instructor in Singapore

. Participated in unit commissioning activities in Singapore

Ibuprofen Manufacturing Team Leader (1/9/1991 - 1/1/ 1999)

. Commissioned and validated computer and operations systems

. Managed a shift of 7 Manufacturing Operators.

. Responsible for organizing commissioning, validation and production

activities on site.

. Supervised a team in all phases of bulk API manufacturing

Paraformaldehyde and Esters Operator & Shift Supervisor (1/7/1974 -

1/9/1991)

. Youngest plant operator promoted to shift supervisor at age 26

. Managed a shift of 6 Operators

. Responsible for organizing all day-to-day production activities

. Accountable for shift performance

. Worked 24/7 rotating shift operations (4 - 8 hour shift rotations)

Education:

. High School Diploma (National Honor Society Member)

. Texas A & I University hours towards a Chemical Engineering degree

Language, Computer Skills:

. Fluent in Spanish

. MS Project, MS Excel, MS Word, MS Visio, Power-Point, ERP,

JD Edwards, Maximo, SAP R-2 & R-3 systems.

. DCS Operations: Bristol, Honeywell TDC 3000, Siemens/Moore

TDC and Emerson Delta V

Certificates, Licenses, Registrations:

. Emergency Team Captain, Haz-Mat Certified

. ISO 14001 Internal Auditing Certified

Additional Training:

Competent Manager Training Managing Emotions Under Pressure

Workplace Conduct Training Coaching For Results

Situational Leadership I & II KT Problem Solving

Employment Law for Managers Managing With the Law

Selecting Top Talent for Recruiting Lean Mfg for Leadership

Managing to High Performance Lean / Kanban for Mfg

Preparing for FDA Pre-Approval The Five S System

Employee Mentoring and Coaching Class A Journey

Project Experience Breakdown:

Ibuprofen Pharmaceutical Project - Team

Leader - in 1991

Developed and executed commissioning

procedures

Developed and executed training material

for operations

Coordinated equipment commissioning and

sanitation

Esters Singapore Project - Training

Manager - 1999-2001

Developed training and certification

criteria for Singaporean Nationals in the

US and the Singaporean Government

Participated as a classroom instructor in

the Texas Bay City, Pampa and Singapore

plant sites

Participated in unit commissioning

activities in Singapore

Certified on the Concord methodology for

SOP development

Rhode Island Enbrel with Immunex/Amgen -

Senior Supervisor 2002 - 2003

Participated and completed all

commissioning and validation activities

Participated and completed conformance

runs

Participated and completed the 1st FDA

PAI process

Licensed for Enbrel production

Rhode Island Enbrel $1,000,000,000

Project - Area Manager - for Amgen June

2003- October 2006

Rhode Island Enbrel $1,000,000,000

Project - Area Manager - for Amgen June

2003- October 2006

Coordinated engineering commissioning

activities with operations

Coordinated all area validation

activities

Conformance Run operations for the area

Planned and interacted with the FDA

agency

Performed and coordinated area

inspections with operations and PQA

groups

Oceanside CA. Avastin - Mfg. Manager Oct.

30, 2006 - April 15, 2008

Completed FDA PAI process

Received final FDA approval six weeks

later

Received EMEA approval

Multi-Product Conversions from Avastin to

Rituxan

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