Manager Manufacturing
Resume:
ROBIN S. ROXAS
Somerset, New Jersey 08873
******@********.***
Objective: An executive level Operations / Engineering / Maintenance position.
Summary:
• Performance driven Director / Manager with extensive experience in leading various departments.
• Recognized as dynamic, passionate, and versatile with the ability to implement successful operations,
drive profitability while developing and motivating teams.
• Twenty nine years pharmaceutical industry experience, mostly in Operations managing up to 200
personnel, with responsibilities include managing Engineers, Manufacturing Technicians, manufacturing
and packaging equipment and facility personnel, in a manufacturing environment.
• Result oriented:
o Grew productivity and achieved quality throughput,
o Reduced workforce by 30% with lean and efficient labor utilization,
o Led successful implementation of preventive, predictive and corrective maintnenance (utilizing
CMMS) systems; reliability engineering maintaining compliance with critical systems;
o led packaging equipment automation with vision recognition and verification systems; execution
and timely completion of capital projects, including equipment installation, and qualification
and facility upgrade; implemented OEE monitoring and increased equipment throughput.
o success in new product launches; managed the product technical transfer and process
improvements.
o Minimized the OSHA recordable accident rate by emphasizing the health and safety of the
department personnel, achieving the company goals for no lost time rate.
o Accomplished the lifting of the Consent Decree by developing and implementing corporate
standards and operating procedures for FDA regulated company sites.
• Managed the selection, purchase, installation and validation of high speed packaging lines and
automation systems.
• Managed the new site contruction and project management.
• Managed Clinical Manufacturing and Packaging operations, up to FDA approval and commercial
production.
• Excellent team player. Work well with management, corporate and operations personnel.
CREDENTIALS
Worked in the field of Engineering, Operations, Materials Management, Quality Systems and Sales of
liquids, solid dosage, aerosols and ointments’ drug products for over twenty nine years and have made
steady advancements in responsibilities. Particular strengths are effective communication skills, employee
motivation, interface with all levels of personnel, management and consultants, customer relations, quality
compliance & implementation, production improvement and sales growth.
I. WORK EXPERIENCE
SCHERING PLOUGH CORPORATION
Schering Technical Operations
Packaging Maintenance Department
2000 Galloping Hill Road
Kenilworth, New Jersey 07033
Manager, Engineering and Maintenance (2003 – 2008)
• Areas of responsibility included ensuring maximum performance from the mechanical staff,
assisting employees to troubleshoot equipment and systems, maintaining equipment and product
quality and efficiencies, equipment rebuilds, providing training, providing timely and accurate
communications, ensuring all local and national regulations are followed such as cGMP, OSHA
safety, environmental, etc.,
• Represented company in bargaining unit contract negotiations.
• Managed the maintenance of stockroom spare parts and change parts inventory control,
• Maintained operational documentation such as set up sheets, set up procedures, preventive
maintenance, corrective work orders, calibration, housekeeping, change control, SOPs, pass down
logs, batch records, etc.,
• Maintained administrative documentation such as training records, attendance, progressive
discipline, appropriation requests, and ensuring that all employees meet compliance with regards to
GMP procedures, qualifications, equipment skills, craft skills and GMP training.
• Pursued the installation and implementation of OEE system to improve equipment efficiency
performance.
SCHERING PLOUGH CORPORATION
Worldwide Quality Management & Systems
Quality Systems Manager (2001 – 2003)
• Areas of responsibility included development, implementation and deployment of Level II Quality
Standards across all FDA and non-FDA regulated sites worldwide. The operational areas involved
were: Sterile and non-Sterile Production, Labeling & Packaging, Validation, Critical Systems,
Process Equipment, Equipment Qualification, Calibration and Maintenance Systems.
• Adviser in the corrective action plan and audit preparation at the Puerto Rico facility sites.
• Quality Systems Expert and Conference Facilitator with the FDA regulated sites in meeting the
cGMP Workplan development and commitment, therby completing all requirements with the
Consent Decree.
• Worked with consultants in the remedial actions taken to assist FDA audited facility sites.
TYCO INTERNATIONAL Ltd. (now Covidien)
Tyco Healthcare
MALLINCKRODT Pharmaceutical
Hobart, New York 13788
Materials Manager (2001)
Operations Manager (1998 - 2001)
Director of Manufacturing (1993 - 1998)
Director of Packaging (1991 - 1993)
• Areas of responsibility included Liquid and Solid Dosage Manufacturing, Bottle/Pouch/Blister
Packaging, Capsule Sealing, Clinical Packaging, Engineering, Maintenance and Materials Management
(Warehousing, Shipping, Purchasing, Planning and Scheduling).
• Directed/managed Manufacturing and Packaging Plant Operation of over 200 employees. Interfaced
with Regulatory Affairs, Quality Control, Quality Assurance, Research and Development, Validations,
Engineering, Cost Accounting, Finance, Marketing, Scheduling, Purchasing, and other manufacturing
department personnel to coordinate and accomplish company objectives. Responsibilities included:
• Start-up and validation of new manufacturing facility. Completed product transfers in a timely
manner.
• Implemented departmental labor reporting system for efficient labor utilization. Assisted in product
costing.
• Pursued employee training programs on machine operations, current Good Manufacturing Practices,
safety and standard operating procedures.
• Worked on process improvements resulting in more consistent assay and dissolution results.
• Customer interface with contract and clinical manufacturing business.
• Updated all products’ manufacturing process validations.
• Equipment and facility improvements in engineering, capital justification, purchasing, installation,
operational and process qualifications.
• Worked with new product development projects and formulations up to scale-up production batches.
• Initiated plant and equipment calibration program.
• Supported the sales business with new and existing customers.
• Managed Materials Requirement Planning program to effectively reduce inventory, improve
material availability and utilization. Created a warehouse locator and improved materials tracking
system.
• Pursued improvements on computerized inventory control and customer order reporting system.
GOLDLINE LABORATORIES (now Teva)
Division of IVAX Corporation
Fort Lauderdale, Florida
Director of Packaging Operations (1989 - 1991)
• Responsible for packaging vitamins, over-the-counter drugs and prescription drug products.
• Managed an operation of over fifty (50) employees from Warehouse Receiving, Production
Planning, Scheduling, Packaging to Shipping of finished goods to various distribution centers in the
US.
• Implemented computerized system for product inventory, shop floor control, capacity planning and
production performance reports.
• Developed employees’ training program for machine operations, Current Good Manufacturing
Practices and Safety.
• Implemented the Unit Dose Thermoforming operation for prescription and controlled drug products.
• Justified the in-house manufacturing and packaging of liquid product.
SCHERING PLOUGH CORPORATION
Kenilworth, New Jersey
Packaging Equipment Supervisor, Mechanical (1986 - 1989)
• Managed a department of twenty (20) packaging mechanics in an unionized environment.
• Responsible for up to twenty five (25) packaging lines involving various packaged products.
• Established procedures to standardized mechanical training and to upgrade equipment.
• Supervised the installation of packaging equipment.
• Implemented downtime reporting system to specify and improve the nonproductive areas.
BRISTOL LABORATORIES
Division of Bristol-Myers/Squibb Corporation
Syracuse, New York
Packaging Department Head (1981 - 1986)
• Supervised a department of fifty (50) employees.
• Developed Standard Operating Procedures to comply with Safety and current Good Manufacturing
Practice requirements.
• Responsible for installation, start-up and maintenance of packaging equipment.
• Recommended packaging equipment and prepared capital expense appropriation for machinery
improvement.
Industrial Engineer (1979 - 1981)
• Prepared appropriation requests to purchase equipment.
• Analyzed capacity studies on the existing manufacturing facilities.
• Developed methods to optimize labor utilization.
III. EDUCATION
B.S. Industrial Engineering and General Management,
Minor in Mechanical Engineering
De La Salle University, Manila, Philippines ‘1978
IV. ASSOCIATION MEMBERSHIPS
Institute of Industrial Engineers (IIE)
International Society for Pharmaceutical Engineering (ISPE)
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