NED MESSER

SKILLS

Maintain facilities and manufacturing

systems in compliance with GMP

and applicable regulatory agencies

Expertise in cGMP/FDA principals

for pharmaceutical and medical

industry

Project and maintain facility budgets

and plans

Comply with FDA and OSHA

requirements

Validate equipment for cGMP

Write SOP’s and PM for plant

equipment

Proficient with Microsoft Office

Suite, Delta View for Plant

Manufacturing, Building Control,

Security, and C.A.T. Architectural

Maintain vendor relationships and

communication for PM programs

Read and understand engineering

plan drawings

Packaging and canning lines

Mixers 25, 50, 75 and 100

CERTIFICATIONS

Blue Print Reading

Building Space Managements

Fiber Optics Installation

Leed - Building Design and

Construction

Metasys - Building Control Systems

Delta V Plant Controls

Accomplished facilities manager offering 20+ years of experience, with an expertise in managing research and development (R&D) labs, as well as medical and pharmaceutical technology plants.

PROFESSIONAL EXPERIENCE

Nexgen Pharma. September 2018 – November 2018

Supervised maintenance and facilities operations for all equipment and building upkeep.

• Supervised first and second shift maintenance crews

• Maintain contact with all outside vendors

• Oversaw PM’s and SOP's

• Met with department heads to discuss and implement their needs

• Cost reduction

• Safety classes and walk throughs

Bacham Americas Inc. June 2017 – October 2017

Temporary Project Manager

Manage the installation of a $2 million GMP validated and FDA approved plant producing small peptides, starter materials for API's, and other pharmaceutical materials.

• Installed multiple reactors, a filter dryer, a chiller, P.T.F.E. glass, and acid piping to ensure that projects run on time and to plan.

• Handle inspections, verify testing procedures, liaise with vendors, and write PM's and SOP's for all equipment.

Arena Pharmaceuticals Inc. August 1997 – June 2017 Facilities Manager

Supervised the maintenance and operating status of the facilities and managed design, construction, security, shipping/receiving, housekeeping, and manufacturing departments.

• Served as liaison for the City of San Diego and building leaseholders to ensure clear communication and permitting.

• Oversaw a 400,000 square foot facility with seven buildings, a 23 acre campus, and an FDA approved cGMP manufacturing plant. o Buildings consisted of 61 fume hoods, a 15,000 square foot vivarium, and a 40,000 square foot scale up plant with chemical reactors and aseptic chemical processers.

• Actively evaluated corrective action plans for facility system repairs, replacements, and modifications.

• Worked with EH&S on writing SOP’s, and handled building design information in order to obtain required permits.

• Held meetings with quality assurance, quality control, VP of operations, and department managers to discuss project needs.

• Maintained vendor relationships for quotes/contracts, verifying that vendors comply with company safety requirements.

• Designed and oversaw the construction of 75,000 square foot Gold Leed office building with a 1,237 panel solar system. EDUCATION

Mechanical Trade School – Diploma

951-***-****

ac7v5k@r.postjobfree.com

Temecula, California

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