Manufacturing Manager

Joel Cruz

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

Address: *** ********** ** ********

City: Riverhead

State: NY

Zip: 11901

Country: USA

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

Skill Level: Management

Salary Range: $75,000

Willing to Relocate

Primary Skills/Experience:

See Resume

Educational Background:

See Resume

Job History / Details:

JOEL F. CRUZ GOMEZ

Villa Marina, Calle Baha Oeste C-77, Gurabo, Puerto Rico 00778

939-***-****/ *********@********.***

SUMMARY OF QUALIFICATIONS

Five years experience in the Biopharmaceutical Industry as Senior Manufacturing Associate and two as Active Manager. Bilingual with effective verbal and written communication skills. Computer literate in Windows, Outlook, Power Point, WERUM, VBA programing, PRISMA, RT Reports, PCS, Track wise and MAPS. Excellent organizational skills and leadership attributes. Initiative in solving problems and ability to work in a challenging environment. Adapts to changing duties and responsibilities and performs duties under stress.

PROFESSIONAL EXPERIENCE

AMGEN MANUFACTURING LIMITED, Road 31 2005 - Present

KM 24.6 Juncos. Puerto Rico

Sr. Manufacturing Associate Active Manager (Upstream Downstream)

Perform set-up and operates new complex critical processing equipment like Bioreactor, Centrifuges, SP column, UF/DF, MF/DF Autoclaves

Aseptic techniques expert

Lead the Team during day-to-day activities

Responsible for evaluation and optimization of process

Responsible for review of manufacturing procedures/batch records

Document owner: draft, reviewed and approved critical documents

Plan and implement long-term complex improvements within system/equipment area of responsibility

Responsible for resolving problems during operations

Implement corrective action and write reports for complex problems

Serve as a liaison with Process Development

Assist with design

May interact with FDA inspectors

Initiate and investigated NCs and CAPA implementation

Change Control Owner

Promote a healthy work environment

Participate in special projects

Maintenance schedule adherence

EBR, SAP WERUM super user

Project management techniques

Perform checks valve prior startup

Projects in Process Development

Multivariate Data Analysis (MVDA

Pre-screening of Yeast

Operate and maintain lab-scale bioreactors

Perform research fermentations to characterize strains

Take samples and analyzed

Participate in group and project meetings

Search read and evaluate relevant scientific literature

Prepared solutions and media for scale up experiments

Prepared, clean and autoclave lab ware

Pfizer Pharmaceuticals, Caguas, Puerto Rico 1998 - 2005

Sr. Pharmaceutical Manufacturing Operator

Execute manufacturing operations such as: weighing, granulation, compression, capsule filling, Packaging or other manufacturing operations in the manufacturing area.

Responsible for clean up the machines and rooms at the beginning and the end of run. Set up process and operate the equipment in each working center.

Follow up the instruction given in manufacturing record and follow the indication in the current SOPs.

Complete documentation in manufacturing record and verify manual entries in manufacturing record as a second operator.

Perform IQ (instrument qualifications), OQ (operational qualifications) and PQ (procedure qualifications) protocols for manufacturing utilities area.

Ferrero of Puerto Rico, Caguas, Puerto Rico 1997 - 1998

Chemical Operator (CTS Temporary Assignment)

Responsible for the proper operation of blending, compression, granulation and coating.

Center of Environmental Toxicology, UPR Medical Science Campus, Hato Rey, Puerto Rico 1996 - 1997

Laboratory and Field Technician

Responsible of recollecting field samples

Perform toxicology tests

Execute PQ for laboratory equipment and prepared proposal and scientific report.

Assist with initial startup experiment with pilot scale equipment

Maintain the biological and analytical laboratory and perform analytical assays

Generate purchase orders and received shipments for the laboratory

EDUCATION

University of Turabo, Gurabo, Puerto Rico

MBA, Business Administration with a major in Human Resources

University of Puerto Rico, Humacao, Puerto Rico

BS, Natural Science with a major in Marine Biology

Penn State University, University Park, Pennsylvania

Certificate in Fermentation Methods Scale-up Strategies

University of Puerto Rico, Mayaguez, Puerto Rico

Certificate in Upstream Bioprocesses for Biotechnology Manufacturing

University College of Professional Mediation

Certificate in General Mediation

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