Production Supervisor

Location:

Flower Mound, TX, 75022

Posted:

August 06, 2013

Contact this candidate

Resume:

JOEL MALABUYO

**** ***** ****, ****** *****, TX 408-***-****

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

OBJECTIVE

Obtain a position as a Production Supervisor

SUMMARY OF QUALIFICATIONS

. Over 13 years of professional experience in pharmaceutical

manufacturing, 8 years overseeing the manufacturing of protein based

products in a cGMP environment

. In-depth knowledge of validation processes and understanding of

validation protocol execution requirements

. Extremely knowledgeable and experienced in aseptic processing within

an ISO 5, 6, 7, and 8 clean room environment. Possess expertise in

operating and troubleshooting process equipment.

. Effective at multitasking and working under pressure to meet

production schedule as well as accomplish overall objectives.

Excellent communicational skills, able to collaborate effectively with

functional and cross-functional teams

. Experienced in managing complex projects, tasks, and processes within

manufacturing operations

PROFESSIONAL EXPERIENCE

Pro Unlimited, San Carlos, CA (Assignment at Novartis Corporation) October

2012-Present

Deviation Specialist Commercial Manufacturing

. Work with line units to author/draft deviation reports related to

commercial manufacturing

. Resolves investigations and deviations to meet lot release time lines

. Participates and leads quality investigations utilizing QA tools and

follows up on corrective actions to closeout deviations

Boehringer-Ingelheim Inc. / Amgen Inc., Fremont, CA 2006-

September 2012

Specialist Manufacturing, Fill/Finish

2009-2012

. Ensure all deviations are triaged within the established time frames,

act as a deviation owner, author investigation reports, execute

Corrective/Preventive Actions, and own Change Controls utilizing

Quality Systems

. Support Manufacturing Compliance (includes support of Cell Culture and

Purification department) through deviation and change control

ownership; knowledgeable in cell culture and protein purification

concepts

. Develop and approve Standard Operating Procedures (SOPs), training

modules, and memoranda necessary to implement GMP processes

. Act as project lead to establish training qualifications for operators

and technicians. Ensure training method increases accuracy and

efficiency within the filling process

. Maintain primary gowning qualifications for all personnel working in

the Aseptic Filling Area

Lead Senior Associate Manufacturing, Fill/Finish

2006-2009

. Coordinate and schedule essential daily activities for product fill

preparation. Delegate assignments to operators in order to meet the

production schedule.

. Perform complex processes according to SOPs and batch records

associated with drug product filling in an aseptic environment.

Responsible for the aseptic processing of pharmaceutical components

and products using cGMP standards while maintaining the production

schedule and adhering to SOPs

. Operate, setup, maintain, and troubleshoot filling equipment such as

the IMA Filler, Genesis West Capper, HAMO Washer, Pentec Vial Washer,

and Fedegari Autoclave to ensure successful production. Work with in-

house facilities to maintain and trouble-shoot process equipment.

. Work with vendors to design and fabricate customize materials needed

for the filling process.

Genentech, Inc., South San Francisco, CA

1998-2006

Pharmaceutical Filling Supervisor, Fill/Finish

2004-2006

. Hire and supervise new technicians. Set training and development

goals, evaluate employee performance, manage attendance and counsel or

discipline employees if needed.

. Drive the production schedule and report resource and capacity

constraints to management and logistics.

. Ensure that cGMPs, good documentation, safety, training, and

housekeeping standards are followed by technicians.

. Effectively communicate with peers, QA and management to resolve

problems and achieve resolution for manufacturing deviations and

anomalies.

. Review and approve manufacturing batch history records and other