Project Manager Quality Engineer

FRANK MATOS 631-***-****)

Experienced Project Manager and QA Manager with over 20 years in the pharmaceutical industry.

Have direct work experience with the following types of businesses - nutritional supplements, OTC’s,

generic drugs and brand name drug companies. Extremely knowledgeable with GMP’s, FDA/ICH and

OSHA guidelines and have worked closely with validation groups, QC labs, all manufacturing

departments, purchasing and franchise management groups. Substantial exposure with the regulatory

process (i.e. CMC review, conducting appropriate clinical studies, etc.) that would be needed for FDA

drug approval.

PROFESSIONAL EXPERIENCE

HOFFMAN RELOCATION MANAGEMENT, New York, NY 03/2014 – 06/2014

Project Manager at Pfizer

• Coordinate relocation for laboratories and over see set up of all analytical instruments

• Economized on number of moving trucks by coordinating maximum load of daily shipments

• Determine accurate amount of daily manpower and moving trucks needed for move

• Coordinated use of refrigerated moving trucks, as needed, for cold storage items

• Used document control structure to assure that all laboratory equipment and analytical

instruments are accounted for prior to move

• Used document control structure to locate upcoming placement of equipment and analytical

instruments

• Assisted with coordinating timing, budget and maintain scope for move

• Coordinate all analytical instrumentation vendor support for instruments that require vendor

assisted re-installations

• Used technical drawings of building for floor layouts and lab bench layouts

• Manage complete transfer of all personnel office equipment and all IT equipment

PACKAGE ALL, Bayport, NY 11/2012 – 08/2013

Quality Assurance Quality Control Manager and Quality Engineer

• Develop and enforce all QA/QC guidelines and regulatory policies with a 5 person Quality

team

• Coordinate NSF audits for GMP compliance. Have retained certification for two consecutive

audits in the past 7 months

• Oversee control of components and drug product containers, closures and closure liner

materials

• Provide corrective and preventative action documentation for any cGMP issues

• Generate or revise SOP's in order to address any CAPA's to warehouse and shipping process

• Coordinate fire marshal inspections at both Bayport and Ronkonkoma facilities

• Audit all Package All suppliers for GMP compliance and OSHA compliance

• Perform all quality duties for Package All regarding our vendors. Obtain all DMF-LOA's,

Specifications and drawings, CofC and CofA's and any official QA letters to customers

• Knowledgeable with CFR parts 211 and 820

MERCK - SCHERING PLOUGH, Rahway, NJ 05/2012 – 11/2012

Project Manager III

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FRANK MATOS

• Responsible for all deliverables under the product registration management related integration

projects. This project was for the harmonization for the two companies, product registration system

• Primary duties was to develop and measure progress for all project deliverables through

departmental meetings. This was documented through MS project schedules, presentations of

project progress, leveling resources and work with multiple team

• Extensive experience with all MS office programs.

• Extensive experience in the pharmaceutical industry and can lead cross functional teams/groups

to the ultimate goal of accurately guiding ANDA or NDA projects through commercialization

KABCO VITAMINS AND NUTRITIONAL SUPPLEMENTS, Amityville, NY 01/2011 – 04/2012

Associate Director of Operations and Quality Engineer

• Lead cross functional teams to develop processes

• Oversee analytical R&D group with determination of difficult separations on HPLC, UPLC and

HPGC analysis towards the detection of impurities

• Review incoming raw materials receipt and testing

• Provide oversight and mentoring for use with HPLC empower 2 upgrade software and

empower 3 data chromatography software

• Coordinate and oversee all OQ and PQ of HPLC and HPGC instruments

• Generate CAPA and deviation investigation for analytical testing groups, manufacturing groups

and batch records

• Modify or generate new SOP's for manufacturing and testing groups

• Oversee QA/QC functions to establish formal product approval procedures, significantly

increase GMP training and compliance

• Provide oversight for all batch records release including manufacturing operations, product

testing and stability, method development and validation, tracking of raw materials and API’s,

shipping, etc.

• Prepare facility for GMP audit for GMP certification from NSF and NPA organizations.

Reviewed prior GMP inspection report from prior audit and addressed all citations to the

satisfaction of the inspection officer

NYCOMED US, Melville, NY 06/2008 – 12/2010

Associate Project Manager, Project and Portfolio Management

• Effectively manage multiple projects simultaneously including successful product launch/kick-

off meetings of various products.

• Coordinated and managed interdepartmental meetings to ensure timely project deliverables and

escalated foreseeable delays immediately to all stakeholders.

• Some of projects managed are (Fluticasone propionate (Cream and Foam), Adapalene Cream,

Aclometasone Dipropionate Cream, Imiquimod Cream in Foilpacs.) Product names available on

company website

• Develop and maintain Gantt charts and MS PowerPoint presentation slides for project updates

and tracking

• Focus on critical path items and advise interdepartmental team on allotted time to a given

milestone

• Provide to all inter-departmental groups, project timelines that includes but is not limited to,

product launch, procurement of FDA/ICH material, timing for scale up batch and completion of

stability data, marketing group input, CMC completion, FDA IND meetings requests, clinical

studies, packaging/creative services, FDA pre-approval meeting requests etc...

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FRANK MATOS

• Advise senior management and other stakeholders on project progress.

• Coordinate and advise with AR&D, PPD, Validation, Production, QA/QC, Manufacturing,

Regulatory Affairs, Clinical (GCP), Planning, Commercial, Purchasing groups

DEL LABORATORIES, Farmingdale, NY 09/2002 – 06/2008

Laboratory Manager R&D Analytical Services and Quality Engineer

• Manager of department which includes - Method development and method validation, stability

program and package testing group

• Extensive use and mentoring of HPLC and HPGC instruments

• Performed OQ, PQ of all chromatography instruments in the lab

• Manage and coordinate all project activities associated and involving the analytical services

group (e.g. validation, equipment factory acceptance testing, equipment calibration and testing,

resource planning, etc)

• Provide methods transfer studies for use of approved analytical testing methods to satellite QC

facilities

• Assign and oversee the timely completion of all lab projects (i.e. R&D method development

studies and method validation reports, manufacturing equipment cleaning validation studies and

reports, method transfer studies, ICH and cGMP compliant product stability studies, analytical

testing of primary packaging studies)

• Responsible with performing CAPA's. OOS data investigations, root cause analysis studies,

develop or revise all lab SOP's

NASTECH PHARMACEUTICALS, Hauppauge, NY 07/1996 – 09/2002

Analytical Chemist R&D

CIRCA LABORATORIES, Farmingdale, NY 09/1994 – 06/1996

Analytical Chemist III

DEL LABORATORIES 07/1991 – 09/1994

Quality Control Chemist

EDUCATION

Bachelors of Science (Psychology); 06/1988

STATE UNIVERSITY OF NEW YORK ; Stonybrook, NY

• Project and Portfolio mgmt for pharmaceuticals – ASMI (14 PDU credits) 4/7/2010

• Microsoft Office 2007 training – Executrain of Long Island 9/15/2009

• MS project 2003 level I + II – New Horizons computer learning center 4/6/2009

• GPhA Fall Technical Conference – 10/28/2008

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