Manufacturing Director/ Operations Manager

Address: Rio Hondo *

AG-**, Rio Herrera Norte Street

Bayamon, P.R. 00961

Cellular Phone: 939-***-****

Email: ***********@*****.***

SUMMARY OF QUALIFICATIONS

Over thirty-five (35) years’ experience in the pharmaceutical industry. Experienced in manufacturing, planning, purchasing, warehousing, packaging and engineering departments procedures for sterile and solid dosage forms, semi-solids, special compounds. Well experienced in the areas of investigations and compliance, standard operating procedures, batch records, and project management. Also, experience with medical devices and veterinary product sales. Extensive knowledge of FDA & Drug Enforcement Agency (DEA) guidelines and regulations, policies and procedures.

Key strengths include:

CGMP audits

Project Management

Manufacturing Investigations

Management of Plant Operations

Time management

PROFESSIONAL EXPERIENCE

WBDCORPORATION / CREATIVE RESEARCH

BAYAMON, PUERTO RICO 2012 – PRESENT

OPERATIONS MANAGER

Start-up and launch of veterinary products marketing, sales and distribution to agriculture centers. Territory had over 300 points of sales. Manage the promotional presentations to multiple key stores to improve market penetration. Train salespersons into the day to day field operations and reports. Direct all new products additions for dog grooming products as well as horse hygiene products. Management of the sales team.

RF TECHNOLOGY - FORT LAUDERDALE, FLORIDA

Review of manufacturing facilities design and re-modeling for OTC products manufacturing.

Conduct GMP audits for the manufacturing and processing of chemicals facilities for FDA compliance.

Evaluate and suggest proper lay-outs for multiple business activities. Review contractors and vendors compliance program to meet FDA guidelines and regulations. Conduct GMP audits for facilities compliance in the areas of manufacturing and processing of chemical facilities for FDA compliance. .

LEGACY PHARMACEUTICALS -HUMACAO, PUERTO RICO

PLANT MANAGER 2011 - 2012

Responsible for Contract Manufacturing Operations of the site. Management of the manufacturing, packaging, purchasing, planning, warehousing, and engineering departments. Pharmaceutical manufacturing included solids dosage forms, semi-solids, special compounds. Responsible for controlled substances procedures to be compliant with FDA and DEA guidelines and regulations. Weekly interactions with customers to review scheduling priorities and/or product specifics.

WETECH PRODUCTS- BAYAMON, PR 2007 - 2011

OWNER

Responsibilities: Exclusive sales and distribution of “Smooth Shapes” medical device for Puerto Rico and the Caribbean. Major activities associated to this business included: start-up of sales and marketing strategies, visits to physician’s practices and SPA centers in PR & Dominican Republic.

PATHEON (FORMER MOVA PHARMACEUTICALS) - MANATI,PR 2004 – 2007 MANUFACTURING DIRECTOR

Responsibilities: Multiple contract manufacturing facilities. Compliance with FDA guidelines, regulations, and manufacturing operations for pharmaceutical solid dosage forms including controlled substances.

TUNNELL CONSULTING- KING OF PRUSSIA, PA AUGUST 2000 - 2004

SENIOR PHARMACEUTICAL CONSULTANT

Responsibilities: Perform an integrated range of consulting services in the Life Sciences practice for Wyeth Pharmaceuticals in New York and Puerto Rico. These services included re-validation of product, technology transfer, process improvement, quality assurance and compliance. Assignments included remediation for a mayor pharmaceutical manufacturer under Consent Decree environment.

IVAX PHARMACEUTICAL CORPORATION- ST. CROIX, V.I. JAN–JULY 2000

PLANT MANAGER

Responsible for solid dosage forms (antibiotics) Manufacturing, Packaging, Engineering, Technical Services, Planning and Purchasing Departments. Collaboration with the Quality and Compliance leadership team to assure a quality and complaint operation with the regulatory agency guidelines and regulations for distribution in the USA market.

IVAX PHARMACEUTICAL CORPORATION – CIDRA,PR 1995 - 1999

MANUFACTURING & PACKAGING DIRECTOR

Responsibilities: Supervision of the Manufacturing and Packaging team leaders to assure a coordinated effort of all activities for the manufacturing and packaging of generic antibiotics (solid dosage forms) of a yearly output of 2 billion units. Assure compliance with local and federal agencies. Preparation of the operational budget in accordance with forecast and capital projects appropriation requests. Control of the master schedule plan and assure purchasing of raw materials and packaging components were purchased on a timely manner.

MYLAN LABS, INC.- CAGUAS, PR 1990 - 1995

PRODUCTION MANAGER

Responsible for the solid dosages and liquids manufacturing department. Total yearly output was 2 billion units.

AH ROBINS MANUFACTURING CO.- BARCELONETA, PR 1983 - 1990

DIRECTOR OF OPERATIONS

Responsibility: Direct supervision of prescription, over-the counter, supplements, and controlled substances products in the form of solids and semi-solids, and a cosmetic product (“Chap-Stick” Lip Balm) with a total of 150 employees. These areas included manufacturing, packaging, purchasing, planning and warehouse operations.

McNEIL PHARMACEUTICAL- DORADO, PR 1980 - 1983

MATERIALS MANAGER, 1982-1983

MANUFACTURING MANAGER, 1980-1982

Responsibilities: Assure the processing of solid dosage forms and elixirs across the manufacturing operations in a timely manner and at the lowest possible cost. Expansion of new warehousing facility.

SCHERING PLOUGH PHARMACEUTICALS, MANATI, PR

STERILE MANUFACTURING DEPARTMENT MANAGER 1975-1979 Responsibilities: Responsible for the aseptic filling, packaging and warehousing operations with over 150 employees.

FERMENTATION PROCESS SUPERVISOR, 1971 - 1974

Responsibilities: Responsible for the facility start-up for the manufacturing of antibiotic and fermentation process.

Evaluation of microbial results to approve the transfer of all media into the scaled-up fermentation tanks.

EDUCATION

CATHOLIC UNIVERSITY OF PUERTO RICO

Bachelor of Science, Chemistry. License 1007

PROFESSIONAL DEVELOPMENT

GREEN BELT CERTIFICATION

Contact this candidate