Quality Assurance Manufacturing

Miguel Pagan

Quality Consultant

Mobile 269-***-**** email: ******@*****.***

Professional Profile

As a Pharmaceutical professional, my responsibilities have included the optimization of

manufacturing processes, scale-up and technology transfer, production of stability, clinical, and

bioequivalence batches and audits of pre clinical studies for GCP, additionally responsible for

managing oral solids manufacturing activities in a Pharmaceutical Contract Manufacturing

Company and Management of Analytical Department maintaining GLP and data review.

Deviations, CAPA, Root cause analysis, Investigations, Manufacturing QA, Audits, Manufacturing

Equipment Qualification, Laboratory Equipment Qualification, Cleaning Validation, Process

Validation, and Analytical method validation. Organic chemistry, scale up, Isolation of intermediates,

API Synthesis, Chromatography, API purification, characterization, Data Review, Batch record

review.

Equipment/System Expertise

Laboratory Equipment Investigations

Solid Dosage Equipment Deviations

Liquid filling Equipment Root Cause/CAPA Customer complaints

Equipment Qualification IOQ/PQ

Professional Experience

Genzyme Corporation Alston, MA (May – Sept. 2013)

QA Validation / Lab Equipment Qualification (contracted through Eliassen Associates)

• Provided quality oversight to the design, qualification, validation, and operation of the

assigned laboratory instruments, and processes.

• Identified potential issues during the design and implementation stages and recommend

solutions.

• Reviewed requirement specifications (such as user requirements and functional

specifications) and all related qualification and validation protocols and reports

• Reviewed and approved Design Review Reports, Design Qualification and Reports,

Qualification documents, and Validation Protocols and Reports, including IQ/OQ/PQs.

Shire HGT, Cambridge, MA (July 2012 - January 2013)

Investigations Consultant (contracted through Eliassen Associates)

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• Evaluate high risk investigations, perform GAP Analysis and provide a historical trend

analysis of state of compliance. Improve deviations, root cause analysis methodology.

Review and evaluate active investigations/deviations process and procedures.

Hospira, Rocky Mount NC (December 2011 – April 2012)

MQA Consultant (contracted through Quintiles)

• Provide compliant manufacturing oversite for large sterile / aseptic manufacturing plant in

their QA activities on a daily basis. Training / mentoring current staff on how to deal with

non-conformance during fill line, labeling line, bottling, tableting, packaging, laser printing,

vision and inspection line. Strategies to prevent deviations and other non-conforming events

during manufacturing.

Apotex Pharmaceuticals Toronto, Canada (July 2011 - November 2011)

Consultant Stability Investigations (contracted through Validant)

• Support, execute, technical resolution and oversight for remediation and closure of stability,

manufacturing and laboratory deviations to determine impact and root cause. Propose CAPA

strategies to eliminate root cause.

Teva Parenteral Manufacturing (March 2011 - May 2011)

Pharmaceutical Consultant (contracted through Vectech Associates)

• Project management for remediation and start up of critical utilities for Teva Parenteral

Manufacturing

• Coordination of construction and demolition of parenteral manufacturing utilities: HVAC,

Clean compressed air, steam, nitrogen and WFI for Sterile core manufacturing site. Review

of document deliverables, URS, FDS, IQ, OQ and design qualification for content and

compliance.

SQA Inc (June 2010 - October 2010)

550 Silver Spur Road, 3rd Flr,

Rolling Hills Estates, CA 90275 USA

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Pharmaceutical Consultant (contract)

• Quality systems audit, gap assessment, batch record review, audit of validation protocols,

cleaning validation analytical method development, manufacturing and process controls

CAPA and complaint evaluation.

Accucaps Industries Limited (June 2007 - September 2010)

Manager of Analytical Services & Quality Assurance

• Drive the improvement and implementation of Customer Feedback, Complaint and CAPA

programs - policies, procedures and ownership deployment and training.

• Data collection and analysis – investigative methods, FMEA, process capabilities and

drive ISO/GMP harmonization including complaint handling, and customer feedback.

• Support the continued deployment of effectiveness checks; specifically as it relates to

audit findings, complaints, adverse events and recalls, trend analysis and root cause analysis.

• Support oversight of vigilance reports, recalls, risk assessments, and safety committees.

• Support reliability initiatives and implementation of best practices.

1 Assure that all quality control procedures are documented and have clearly defined

quality specifications to allow appropriate auditing.

2 Responsible for quality control functions required by the company including but not

limited to in-process, component, and finished goods inspections.

3 Responsible for analytical method development and validation (HPLC, UV-vis, Ir) as

well as policies, procedures, and compliance

4 Daily quality oversight of fill line, purification line, bottling, tableting, packaging, laser

printing, vision and inspection line

5 Write and execute qualification protocols in a timely manner for approval by

management.

6 Collect and analyze qualification data and prepare final reports for approval by

management.

Catalent Pharma Solutions (Cardinal Health) (September 2004 - November 2006)

27 Schoolhouse rd. Somerset NJ

Pilot Plant Manager (Dec.

• Ensure operations adhere to safety and quality

standards as well as maintain production, maintenance, schedule and daily supervision of

pilot plant operators and fill line, purification line, bottling, tableting, packaging, laser

printing, vision and inspection line.

• Responsible for performance management of operators,

provide appropriate training

• Coordinate with project management, logistics and

analytical services to ensure proper planning QA

QA External Manufacturing Auditor (Sept 2004-July 2000)

• Conduct GMP, GLP, or GCP audits (internal and external),

as applicable

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• Maintain material qualification program by working with

Operations and Development groups to ensure appropriate qualification requirements are met

and inspection of manufactured products, raw materials and chemicals

• Conduct audits of Pharmaceutical Development to assure

compliance

• Auditing analytical data, technical reports, method

development, validation and R & D development reports.

• Audit of laboratory notebooks, analytical test methods, and

technical test protocols for GLP compliance with Pharmaceutical development SOP’s.

• Developed project plans including resource assessment,

project strategies, timetables and budget maintenance.

• Escalated issues, deviations, investigations or trends

discovered during the lot review to quality management

• Served on multi-disciplinary project teams to effectively

meet project timelines and compliance to cGMP’s.

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Purdue Frederick Laboratories Inc. (April 2003 - May 2004)

700 Union BoulevardTotowa, New Jersey 07512

QA Consultant (Contract for RCM Technologies)

Audit all activities at facility identifying any cGMP or Quality deficiencies in

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manufacturing, analytical laboratory, facility, QA, contract or validation systems.

Cordis LLC March 2003-April 2003

5 Carr 362 Km San German, PR 00683

QA Consultant (Contract through YOH Scientific)

• Prepare manufacturing site and analytical laboratories for preapproval inspection

Conduct laboratory audits, review analytical data (e.g. HPLC, FT-IR, UV, TOC, etc.)

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Memorial Sloan-Kettering Cancer Center, New York, NY (May 2002 - February 2003)

Manager, Manufacturing -Product Release

Oversee the process of updating and defining SOPs for in-house manufactured products

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and conduct quality assurance audits in compliance with GLP/GMP requirements for in-

house product development.

4 Approve the finished products as “Released”; or “Rejected “; assuring that all pertinent

data are entered into the official lot file.

5 Audit production documents for compliance with federal regulatory requirements (CFR),

specifications and Good Manufacturing Practices (GMP) and Good Laboratory Practices

(GLP).

6 Collaborate with laboratory investigators, Principle Investigators, IND (Investigational

New Drug Committee), the IND Committee Chairman, and the Research Pharmacy on all

aspects of new in-house product development.

Alteon Pharmaceutical, Ramsey, NJ (March 2001 - March 2002)

Research Scientist

Characterization of Alt-711 by H and C NMR utilizing long range and short range

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coupling experiments to verify structure

5 Review and evaluation of analytical methods transfer and validation, evaluation of

manufacturers’ proposals and contracts.

6 Audited three sites in Europe for strict laboratory and manufacturing compliance.

7 Produced a new crystallization procedure that increased yields from 50% to 89%.

8 Improved Alteon's synthetic process for making Alt-711 on a commercial cGMP scale

which involved providing alternate synthetic routes for starting materials in a safe, efficient

and cost effective manner.

9 Implemented SAR database and synthesized new analogues for medicinal chemistry and

patent support.

U.S.Mint, West Point, NY (April 2000 - March 2001)

Quality Control Chemist

Routine assay on precious metals by ICP, AA and fire assay.

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Wyeth-Ayerst Research Pearl River, NY (March 1998 - March 2000)

Research Scientist, Chemical Development

Responsible for identifying, testing, and recommending synthetic improvements to

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existing and newly developed processes.

3 Development of laboratory processes from the bench on gram scale to the pilot plant on

multi-kilogram scale utilizing 1000-liter reactors.

4 Experience collecting and interpreting routine analytical data (e.g., IR, GC, HPLC, NMR

(2D long and short range coupling experiments), GC, and LCMS)

• Isolated stable and unstable impurities by preparative LC. Identified compounds by

NMR, LC-MS and HPLC. Prepared compounds and compared spectra with isolated

impurities.

• Studied first step of MMP inhibitor reaction to generate hydroxyl amine. Process

improvement to eliminate impurities and minimize steps from 13 to 9 overall.

• Transferred technology between process research, kilo lab, glass plant, and pilot plant.

Scaled up synthetic chemicals directly in 22L, 100L and 200L vessels. Reactions included:

oxidations, alkylations, cyclizations, coupling reactions, organometallic reactions,

tosylations, and hydrogenations.

Agouron Pharmaceuticals Inc, San Diego, CA (March 1996 - February 1998)

Associate Scientist, Chemical Development

Experience in providing

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alternative more cost effective synthetic routes to AG 1343 which are currently under large-

scale trials. Skills in transferring technology from a bench level to pilot plant scale.

• Successfully optimized 9-step synthesis to prepare AG 1343 ( TM Viracept) a novel HIV

protease inhibitor currently in production on multi-ton scale with an overall cost of goods

savings between 20-25% over the previous synthesis.

Hoffman LaRoche (July 1990 - March 1996)

340 Kingsland St. Nutley, NJ

Chemical Development Scientist

Applied research and process development techniques in synthesis of vitamin derivatives

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for health, cosmetic, and industrial applications.

3 Scaled-up and optimization of Vitamins and analogues, isolation of side reaction products

impurity identification.

4 Determined process parameters on laboratory scale. Scaled process from 22L flasks to

50-gallon reactor to 400-gallon reactor to 1,000-gallon reactor.

• Experience in large scale reactions requiring chlorinations, grignards, hydrogenations

and metallations.

• Led team in development and scale up of HIV protease inhibitor and human growth

hormone by solution phase peptide.

• Continuous improvement project to structure search used chemical inventory

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Presentations / Publications

Patent No. 200******** “Sunscreen compositions and methods of use thereof.”

Inventors: Martin Gall, Miguel Pagan

Patent No. 6,933,388 “Process for the synthesis of 3-cyano-6-alkoxy-7-nitro-4-quinolones”

Inventors: Pagan; Miguel, Duncan; Scott, Floyd; Brawner

Publication: “A synthesis of the HIV protease inhibitor nelfinavir from D-tartaric acid.

Tetrahedron letters 42”

Inventors: Pagan; Miguel, et al

Education

Bloomfield College, Bloomfield, NJ

BS Chemistry

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