Manager Manufacturing

To Whom It May Concern:

I am well organized and goals/objectives oriented. I have strong problem solving skills. I am a motivator and change agent. I transmit a sense of urgency to my team and can focus diverse talents to a common goal.

I have had positive achievements in various positions. These range from corporate recognition for emergency situation intervention, formal investigations reduction over a specific period and production increases on a particular shift and production area. I have been directly involved in two successful plant start-ups at the manufacturing phase and have established and refined warehouse and operations techniques to increase productivity and efficiency.

I am a proactive individual with excellent communicative and interpersonal skills. I am fluent in both English and Spanish. I possess a Bachelors Degree in Business Administration (Magna Cum Laude/3.76GPA). I have twenty years experience in the Manufacturing area of the Pharmaceutical Industry. I have more than fifteen years experience in management and more than six years in a hands-on operational capacity.

Cordially,

______________________

Hugo J. Orellano

15086 Audubon Lake Blvd.

Gulfport, MS 39503-6240

Mobile 228-***-****

Alternate 410-***-****

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

Hugo J. Orellano

15086 Audubon Lake Blvd. Mobile 228-***-****

Gulfport, MS 39503-6240 ********@*******.***

EDUCATION: Bachelors Degree in Business Administration

Graduated Columbia College University

August, 2000 Caguas, Puerto Rico

CAREER SUMMARY:

• I have progressive accomplishments in both the Pharmaceutical and Flooring industries, promoted to Plant Manager and Operations Manager respectively.

• I possess ten plus years of technical writing skills and I am an experienced trainer and developer of staff.

• My management style is a hands-on, open door, motivator and change agent.

• I have training and experience in 5S and Lean methodologies including Value Stream Mapping, Kaizen and Kanban initiatives.

EXPERIENCE:

Feb 2008-Present ANI Pharmaceuticals Inc

Gulfport, MS

Position Plant Manager

Promoted from Production Manager to Plant Manager within two years with the organization. Lead warehouse racking and reorganization project. Established daily and biweekly meetings for the various operations departments in order to improve overall communication.

Initiated 5-S activities at the Manufacturing, Packaging and Administration areas.

Initiated Cross Functional Safety Committee to perform plant wide audits and establish corrective action plan.

Identified critical equipment/process improvements to maximize efficiency and productivity (e.g. bottle necks ID for improved cycle time, fill sheets with target & upper limits to improve yields)

Identified exempt headcount requirement at the Production department. Recruited and filled the required position for off shift oversight and coverage.

In six months achieved and sustained increased production with improved Right First Time (RFT) documentation metrics results. Established and developed formal training and certification program for Packaging Leaders and line operators.

• Responsible for all operations activities including Manufacturing, Packaging, Maintenance, Purchasing, Shipping and Receiving.

• Through staff members ensuring all personnel evaluations are performed in a timely manner (quarterly) by department. Assist and feedback on rewards programs and disciplinary actions.

• Ensure all departments comply with Standard Operating Procedure (SOP) biennial reviews.

• Train and assist staff in formal investigation and CAPA identification and implementation.

• Direct participation and coaching in recruiting and staffing (both internal and external).

• Reporting of P&L, schedule attainment, capital projects and budget status to upper management.

• Responsible for coordinating implementation of process improvement initiatives.

• Responsible for Safety Committee follow up to ensure all cross functional communication and activities are planned and executed in a timely manner.

Hugo J. Orellano Mobile 228-***-****

Dec 2005-Jan 2008 GlaxoSmithKline

Cidra, Puerto Rico

Position Operational Support Manager

Identified and corrected dangerous and un-hygienic tool-room practices for tooling destruction.

Identified and corrected unsafe storage of flammable cleaning supplies.

Developed and implemented training program for the Manufacturing areas that resulted in 100% compliance for area personnel in the validated ISO-Train system.

Identified and developed key personnel for various leadership positions within the organization.

Established the ‘RFT Champion’ system in order to improve documentation training and flow throughout the organization.

Implemented cross-training initiatives at production areas under my responsibility.

Coordinated 5-S activities at the Manufacturing area and established Kanban system at the warehouse staging for the various Manufacturing processes..

Prepared for various internal and external audits & reviews of processes, cleaning, training, staging warehouse and equipment storage at the Manufacturing areas.

• Responsible for all aspects of the Granulation, Compression, Coating and Sorting /Inspection processes in the Manufacturing Department.

• Responsible for schedule attainment and product quality and other compliance issues directly related to the Manufacturing process.

• Responsible for the compliance of all area associate’s (exempt and non-exempt) training and development.

• Responsible for initiating investigations on a timely basis (within 24 hours of event) and closure of the same including any related CAPA.

• In charge of four exempt reports and indirectly sixty non-exempt personnel. Provide coaching, and aid in the development of all area associates.

• Perform and assist in Performance & Development Plan for exempt and non-exempt reports.

• Provide support to Validation, Technical Support and Remediation initiatives within the Manufacturing areas.

• Assist in Batch Record review and approval providing in-put and feedback as Subject Matter Expert (SME) for the Manufacturing areas.

• Coordinate department cleaning and microbial sampling and monitoring with laboratory personnel and Logistics.

Hugo J. Orellano Mobile 228-***-****

2004-2005 Janssen Ortho LLC/Johnson & Johnson

Gurabo, Puerto Rico

Position Senior Manufacturing Process Facilitator

Attained Supply Chain Excellence Award within the first six months, for leading overtime initiative during holidays, extreme weather and weekend activities, to comply with planned schedule attainment and assure year-end goals were met.

Supported and assisted in Operational Excellences initiatives to develop and complete projects by area personnel for Lean Manufacturing certification.

• Responsible for all movement, use and accountability of controlled drugs used in manufacturing.

• Responsible for all stages of the manufacturing operation on the third shift, from Weighing to Printing (including Solution preparation, Granulation, Blending, Compression, Encapsulation, Coating, Inspection & Warehouse).

• Responsible for Document Review and Batch Record dispatch.

• In charge of manufacturing support (Tooling, Change over, Wash-station).

• Responsible for coordinating warehouse personnel & area mechanics.

• Responsible for Quality Notification Reports (QN) and investigations.

• Responsible for employee performance evaluations, coordinating employee vacations, establishing cross training schedules and ensuring appropriate use of rewards programs and disciplinary actions.

• In charge of all shift personnel including two exempt and all non-exempt associates.

2002-2004 Abbott Laboratories

Barceloneta, Puerto Rico

Position Manufacturing Senior Supervisor

Winner of the President’s Award (2003)-for leading initial process of protecting the physical plant and participating in subsequent plant clean-up and restoration after flood disaster. Plant clean-up was performed in record time and production resumed within two days after the flood. Controlled Drug Agent responsible for the dispatch, handling and accountability of all controlled drugs used in the manufacturing processes.

Coordinated the 5-S activities on the 3rd shift at the Manufacturing area.

• Responsible for the manufacturing Compressing and Coating areas on the third shift at the Pharmaceutical plant.

• Responsible for giving support to the Drug Weighing, Granulation and Finishing areas of the manufacturing department.

• Responsible for assigning tasks and priorities as per production schedule.

• Responsible for employee performance evaluations, coordinating employee vacations and establishing cross training schedules.

• Responsible for recruiting hourly and exempt Manufacturing personnel.

• Responsible for initiating and conducting formal investigations as required by the manufacturing department including establishing CAPA’s and disciplinary actions as needed.

Hugo J. Orellano Mobile 228-***-****

2001-2002 Wyeth Pharmaceuticals

Guayama, Puerto Rico

Position Production Supervisor/Manufacturing

Within six months the manufacturing team reduced its overall investigations by more than 50% and lowered the total number of open investigations from over thirty to less than 10 per month.

This was achieved through an aggressive training program and direct supervision (minimum 50% of the time on the floor in direct contact with the operation).

• Responsible for coordinating the daily tasks of over 30 production operators in order to comply with schedule requirements and providing support to the Coating, Healthcare and Weighing areas of the Production department.

• Coordinated training, vacations and commercial production as well as validation processes and cleaning (as per Technical Services dept. needs).

• Responsible for the verification of the Batch Manufacturing Records as well as specific area and general SOP’s (revision and updating).

• Responsible for investigating any anomalies at the manufacturing stages and establishing the necessary CAPA's.

1995-2001 Watson Laboratories/Danbury Pharmacal

Humacao, Puerto Rico

Position Production Team Leader

Plant Start-up and Commercial operation/worked directly with the Technical Services department to produce the necessary development and validation lots and perform equipment qualifications to insure a successful Plant Start-up. Promoted to, Production Team Leader in less than two years.

• Responsible for scheduling the manufacturing area operator tasks, vacations, sick leave and cross training while assuring compliance with cGMP, projected schedule and corporate policies.

• Perform employee performance evaluations on a quarterly and annual basis. Coordinate and perform practical and theoretical training of the area SOP’s, safety measures and manufacturing equipment processes.

• Verification of all official documentation generated as part of the manufacturing process.

• Revise, update and generate area SOP’s as necessary.

• Enter data pertaining to raw material use in the manufacturing area using the computerized inventory control system BPCS.

• Maintain effective communication with the Materials and Quality departments to assure the availability of approved raw material.

• Support the packaging operation on the second and third shifts as necessary.

• Investigate all manufacturing events and establish Corrective and Preventive measures as needed.

Hugo J. Orellano Mobile 228-***-****

1991-1995 Roche/Syntex Inc.

Humacao, Puerto Rico

Position Production Operator

Plant Start-up and Commercial operation/worked in conjunction with the Technical Services department to evaluate new equipment, perform qualification procedures, produce development and validation lots and optimize production processes. Generate and revise operational and cleaning procedures.

• Weighing, Compounding, Dosage (Encapsulation w/Spheres & Granulation) and Coating

• Assist the Technical Services department in the generation, revision and translation of the area SOP’s and Manufacturing Batch Records.

• Perform operation and training (theoretical and practical) of the manufacturing equipment, safety equipment and material handling equipment.

• Enter all data pertaining to raw material use in the inventory control system MAPICS.

1990-1991 Ethicon-J&J

San Lorenzo, Puerto Rico

Position Production Operator

Swaging, Winding and Packing operations (Medical Device)

1982-1990 Rexx Rug & Lino Co.

Chicago, Illinois

Position Operations Manager

Through personal initiative the warehouse area was organized systematically to reduce total operation time, increase warehouse space and efficiency, facilitate identification and inventory of supplies and material. A first in first out system was implemented which, reduced overall waste and resulted in substantial cost reduction for the operation.

Promoted to Operation Manager in less than two years.

• Responsible for the daily and weekly assignments of over 25 hourly employees and contractors (installation, delivery and warehouse personnel), including 4 to 6 team leaders.

• In charge of all materials purchasing and inventory for two stores and one warehouse.

• Responsible for vehicle (trucks/forklifts) purchase, maintenance, repairs and training.

• Responsible for preparation of all custom orders, commercial and residential deliveries and installations.

• Responsible for recruiting, training and performance evaluations of all non-exempt personnel.

Hugo J. Orellano Mobile 228-***-****

Skills:

• Completely bilingual (English and Spanish) with excellent written and oral communication and interpersonal skills.

• Strong computer skills and over ten years of pharmaceutical investigative experience. With a total of twenty years of Pharmaceutical Manufacturing experience.

• CPR, First Aid & Fire Brigade training.

• Licensed forklift and heavy vehicle driver.

• Hands on experience in the production of solid dosage (tablets/capsules), powder and liquid from weighing to packaging including all of the manufacturing stages.

• I have worked on cost reduction and cycle time reduction projects.

• I have performed theoretical and practical training for manufacturing,packaging and material handling equipment and processes.

Seminars:

• 5-S Methodologies

• The Seven Habits of Highly Effective People

• Kepner Tregoe Technique (investigative methodologies)

• Manufacturing Investigations

• Train the Trainer

• Ethical Behavior and Values Workshop for Managers

• Coaching and Development Seminar

• CGMP for Supervisors

• Hazardous Waste Operations and Emergency Response

• Hazardous Waste Management

• Employee Relations Seminar

References: Available upon request

Contact this candidate