SPENCER Shih-Wei LEE, Ph.D., R.Ph.

*** ********** *****

Orangeburg, NY 10962 (Will relocate to Bay Areas, CA)

Home: 845-***-**** / Cell: 845-***-****

ace089@r.postjobfree.com

SUMMARY

Innovative, creative and effective Pharmaceutical Executive with decades of

experience in numerous major pharmas in Quality Assurance, Quality

Systems/Compliance, Consent Decree Remediation, cGMP Auditing, Pre-Approval

Inspection (PAI), Change Control, CAPA, Validation, Building Automation

System (BAS), Building Monitoring System (BMS), Computerized Systems

Validation (CSV),Technology Transfer, Analytical Method Transfer, Project

Management, CMO (ESP) Evaluation/Selection/management (Sterile and non-

sterile), Clinical Studies, Regulatory Affairs, CMC, Formulation

Development, Process Improvement/Validation, and Clinical supplies

Manufacturing/Distribution, is ready to contribute. Direct contact at

ace089@r.postjobfree.com

. Strong leadership, negotiation, planning and interpersonal skills.

. Compiled/authored and reviewed CMC for IND, NDA (and ANDA) submissions.

. Responded FDA CMC comments, DMF, and 483 deficiencies.

. cGMP Auditing on CMO facilities (Sterile and non-sterile), BAS, BMS, CSV

and training programs.

. In-depth knowledge in all aspects of drug development, technology

transfer, site acceptance, clinical supplies/studies and hands-on

experience in preformulation, formulation/process development, scale-up,

validation, IQ/OQ/PQ, stability, GxP quality audits and troubleshooting.

. Versed in ISO 13845:2003 and FMEA (Failure Mode and Effects Analysis)

implementation.

. Audited (as Lead Auditor) and selected CMO/Testing Lab (External Services

Providers) and managed the Process development, scale-up, validation

(IQ/OQ/PQ), commercial manufacturing and testing of API and drug products

to ensure cGMP compliance.

. Functioned as Clinical Development Teams member,

planned/scheduled/participated in CRO Kick-off meetings and Clinical

Project Team weekly meetings to discuss/review/resolve the Protocols,

GxP, IB, ICF, IRB, EDC, eCTD, eCRF, CSR, Data Management, IVRS, and CTM

logistic issues for the global Phase 1, 2 & 3 studies (in various

therapeutic projects).

. Conducted Internal/external Quality Audits ensuring cGMP compliance and

continual improvement.

. Participated and contributed to FDA PAI (Pre-Approval Inspections in the

US and Asia). Accomplishments resulted in NDA approval in the first

review cycle, and DMF, IND, NDA, ANDA submissions/approvals.

. Excellent networks with GxP consultants and CMO/CRO. Reputable contact

records with FDA DMF Staff, CDER Project Managers, and PAI officers.

. Companies associated: Brand Companies -- Ciba-Geigy (Novartis), Pfizer,

Lederle, Wyeth (Pfizer), McNeil and Merck; Generics Companies -- Ivax,

esiLederle and Forest.

PROFESSIONAL EXPERIENCE

CAL'S Management Inc., Orangeburg, NY (or Modesto, CA)

5/2012 to Present

President

Pharmaceutical Consulting

Provide consultation on how to prevent FDA warning letters and consent

decree by proactively conducting periodic cGMP audits and improving quality

compliance. Conduct Mock FDA Re-Inspection Readiness, Due Diligence

Audits, Validation Report/Review and Technology Transfer. Perform

additional value-added services:

. 483 Warning letters responses.

. Documentation Reviews related to Process/Method Validation/transfer, QC

Lab Control, Change Management, Updating Specifications, Cleaning

Validation and equipment IQ/OQ/PQ.

. cGMP Auditing on CMO facilities (Sterile and non-sterile), BAS, BMS, CSV

and training programs.

. Formulation/Process Development (Immediate and Modified Release),

Technology Transfer and Validation.

. Quality Systems/SOP overhaul/renovation.

. Project Management for R&D, Product Development, Technology/Method

Transfer and their GxP activities.

. Clinical Supplies/Distribution Consultation.

. External Services Providers: CMO, Testing Lab and CRO evaluation,

recommendation and management.

. Foreign vendors' cGMP audits/reporting as "Outside Inspectors" reports to

FDA.

. Medical Device and biological auditing using ISO 13485 & CFR 210 & 211 &

820.

. Investigation, CAPA, Change Control & Management.

. CMC and regulatory submission.

. FDA PAI readiness.

. DMF agent.

Recent Assignments:

. Conducted Mock FDA Audit and provided guidance for FDA Re-Inspection

Readiness for a sterile CMO facility (Manufacturing and Testing Lab) in

Canada. (The Client Passed the FDA Re-Inspection).

. Working as Quality Compliance Consultant (review/certify QC Laboratory

Investigation Reports and evaluate CAPA, etc.) aiming to rectify FDA

warning letter and 483 Observations as to get ready for FDA re-inspection

and cGMP clearance for final NDA approval of manufacturing site in

Taiwan.

. DMF Deficiency Letter consultation.

Merck, Summit, NJ

7/2012 to

3/2013

Merck Manufacturing Division

Global Technical Operations - Execution Strategy and Project Management

External Manufacturing

Senior Technology Transfer Specialist

Conduct Technology Transfer projects (Drug Substances & Drug Products)

following company guideline and contribute to ensure all the Tech Transfer

projects (Manufacturing Process and Testing Methods) to be the most robust,

consistent, compliant and efficient process in the industry.

. Review and analyze Validation Master Plan, Formulation and

Processes/Testing to be transferred (utilizing efficiently my in-depth

experience and skills in Product Development, Process Validation, Method

Transfer and Dosage Forms R&D - Solids, Liquids, parenteral and Creams).

. Evaluate Master Batch Records; assess Annual Product Review, Validation

Reports and Product Quality Reports to draft Technical Package and

Process Fit.

. Participate weekly Tech Transfer Project Team Meetings to discuss/resolve

TT issues.

. Coordinate QA of the Tech Transfer Team Members to review/assess CMO's

GMP related documents.

. Conduct Risk Assessments as per Critical Process Parameters and Product

Quality Attributes to anticipate and remediate potential Tech Transfer

issues and site selection.

. Provide technical expertise (Formulation, Process Validation and QA) to

the Technical Transfer Team.

. Trained in TrackWise as "Change Owner" and "Approver" for Global Change

Management in the Tech Transfer.

. Review CMC, dossier for US and EU submissions.

McNeil, Fort Washington, PA

11/2011 - 4/2012

Quality Compliance Consultant

External Manufacturing QA and Sustainable Compliance

Conducted Quality/GMP Compliance Auditing for FDA Inspection Readiness per

its Consent Decree Commitments and Remediation.

. Reviewed/compiled/corrected Quantic Review Letters for Validation,

Investigations (including OOS), Change Control, Documentation Control,

Complaint, Root Cause Analysis, CAPA and Commitments.

. Reviewed and Tracked CMO's ( and Testing Lab) Quality Agreements,

Complaint Investigation, Contractor Investigation Reports, Root Causes

Analysis, and CAPA.

. Created Spreadsheet detailing Quantic review comments (observations) on

Validation process for Tech Transfer.

. Compiled relevant documents (Complaint Investigation/Contractor

Investigation Reports, Change Control/Management, Notification to

Management, Field Alert Reports, & Escalation to Management) for a proper

closure of the Escalation.

. Compiled Notification to Management and Escalation to Management

activities/timeline for metric evaluation.

. Gathered required documents (such as Final Investigation Reports, FAR,

CAPA & Certificate of Destruction) for Regulatory Compliance to request

FDA for the Termination of Recalls.

SUNOVION, Fort Lee, NJ 2003 - 2011

(Former Dainippon Sumitomo Pharma - DSP and Sumitomo Pharma America)

(DSP acquired Sepraco and changed name to Sunovion in 2010)

Associate Director - GMP QA

Regulatory Affairs and Quality Assurance

Ensured GMP compliant Clinical Trial materials (CTM) for all phases of

clinical supplies/distribution/studies by auditing, monitoring, reviewing

and approving CMO, Testing Lab, GMP validation documents, batch records,

training records, IVRS, CAPA and Investigations closures. Established

global Quality Systems meeting cGMP and ICH guidelines.

Compiling/authoring CMC for IND & NDA submissions. Proactively prevented

any potential GMP deficiency. Actively participated in Phase 1 to Phase 3

global clinical studies and FDA PAI.

. Contributed to the first NDA approval for DSP in the US (Latuda - for

Schizophrenia) in First Review Cycle.

. Reported directly to CEO/President and built QA Department for DSP

starting 2003, responsible for developing and implementing global

strategy and policy relative to Quality Systems Management for R&D.

. Performed Mock audits on parent company (Sumitomo) API, Drug Products and

Cytotoxic Filling facilities.

. Communicated directly with the FDA about DMF deficiencies and Coordinated

for CMC meeting & FDA PAI on Suzuka Plant inspection (2008) and passed

the PAI.

. Compiled/authored CMC from internal relevant departments (Formulation,

Analytical and Stability Groups) and external contractor (CMO),

reviewed/approved final CMC sections for DMF, IND/NDA and annual update

or amendment and for EU registrations.

. Reviewed/approved validation protocols for and monitored a Technology

Transfer.

. Developed audit plan and executed the audit(s) as Lead-auditor. Wrote

Observation Letters and Audit Reports to address the level and state of

cGMP compliance, effectiveness of CAPA and Investigations (including

OOS).

. Conducted cGMP Auditing on CMO facilities (Sterile and non-sterile), BAS,

BMS, CSV and training programs: such as Fisher/Lancaster, Aptuit, Almac,

Bilcare, Catalent, Pharmatek, DSM, Intertek (Testing Lab), TKT (Shire),

Gilead (Both are Sterile facilities - for licensed Injectable products),

Forest, YGK and Quintile & Parexel Depots (South America) to ensure

meeting regulatory requirements.

. Performed special audits for RI-AME studies at Aptuit and Covance (for

GCP compliance).

. Developed global quality policies and departmental SOPs including CSV

(Computerized Systems Validation)..

. Functioned as Clinical Development Teams member,

planned/scheduled/participated in CRO Kick-off meetings (inviting KOL/

Principle Investigators) and Clinical Project Team weekly meetings as QA

Representatives, to discuss/review/resolve the Protocols (for Toxicology,

Clinical Pharmacology and Clinical Studies), GxP, IB, ICF, IRB, EDC,

eCTD, eCRF, CSR, Data Management, IVRS, and CTM logistic issues for the

global clinical studies.

. Served as the Agent of DMF, Label Code and Drug Product Registration

(DRLS) for the Japan parent company in filing/updating/coordinating with

US FDA and Health Canada.

. Coordinated with Europe QA colleague for QP (Qualified Person) release on

CTM.

WYETH RESEARCH (Pfizer), Pearl River, NY 2000 - 2003

Project Manager - Quality Compliance, Vaccine R&D QA (2000 - 2003)

Performed/Monitored gap analysis with the FDA assigned consultant (Quantic

Group) for consent decree commitment and remediation and Conducted monthly

cGMP Audit with Corporate Audit members on three departments (Viral

Development, Analytical Development & Vaccine Clinical Supplies).

. Wrote SOPs, such as Internal Audit for Vaccine R&D QA and provided the

trainings.

. Provided Quality Assurance/Improvement to Vaccine Clinical Supplies

Manufacturing and Distribution (Cold Chains process/shipment/monitoring).

. Assessed and implemented the corporate cGMP Systems thru Quality Council.

. Monitored and coordinated monthly activities of Level I (Company

Policies), Remediation Plan, Level II (Conformance Standards), Level III

(Departmental SOPs), and Quality System Elements (QSE) Assessment.

. Ensured cGMP compliance throughout the R&D activities using Projects and

Trackwise.

Principal Scientist (esiLederle) - Pharmaceutics and Process Development

(2000 - 2001 )

Performed formulation development, reviewed patent and evaluated technology

issues, especially, for the novel delivery systems. Conducted, as member

of Sustainable Compliance Initiative Team, the gap analysis and remediation

for the FDA consent decree.

0. Evaluated several generic novel delivery systems, patents and submitted

for budget approvals.

1. Coordinated/monitored IQ/OQ/PQ programs and reviewed their

Documentations for Pilot Plant equipment.

IVAX PHARMACEUTICALS (Teva), Northvale, New Jersey 1996 - 2000

Manager - Product Development

Managed and conducted formulation/process development, validation and

participated in ANDA submissions.

0. Formulated 13 products with passing BE requirements for FDA submissions.

1. Worked directly (on site) with the FDA Investigator for Pre-Approval

Inspection (PAI).

2. Conducted, monitored the clinical supplies manufacturing and validation

batches.

3. Prepared Product Development Reports and reviewed Validation/Method

Development & Validation Documentations for FDA's PAI and final approval

for commercialization.

4. Participated SUPAC strategies for site transfer and formulation changes.

Prior to 1996: other major pharmas, such as Forest, Ciba-Geigy, Lederle &

Pfizer in Technology Transfer & Technical Support, Preformulation,

Formulation /Process Development, CMC (Immediate and modified released,

solids, liquids, inhalation & Injectable), Process Validation, Scale-up,

Internal GMP Audits, and Clinical Manufacturing (from Powder-in-a-Vial for

Phase I to commercial products for Phase IV clinical studies).

EDUCATION

Ph.D., Industrial Pharmacy, St. John's University, Jamaica, NY

M.S., Pharmacy Administration, Long Island University, Brooklyn, NY

B.S., Pharmacy, National Taiwan University, Taipei, Taiwan

(Took MBA core courses in Finance at Iona College, NY)

PROFESSIONAL LICENSURE AND MEMBERSHIPS

Registered Pharmacist in the state of New York

American Association of Pharmaceutical Sciences

Parenteral Drug Association

Drug Information Association

International Society of Pharmaceutical Engineers

Rho Chi Pharmacy Honor Society

Major Presentations:

1. "Quality System in US Pharmaceutical Industry and A Case Study - Consent

Decree", Feb. 3, 2004. An invited presentation given to Japan

Headquarter (Sumitomo Pharma) colleagues during the first visit (Osaka,

Japan).

2. "GMP Review for Investigational Drugs", Dec. 6, 2005. Global QA Meeting

at Osaka, Japan.

3. "Quality Systems for 21st Century", June 5, 2006. Global QA Meeting at

Fort Lee, NJ, USA.

4. "QA/QC Strategy and Risk Management", Dec 7, 2007. Global QA Meeting at

Osaka, Japan.

5. "Successful Technology Transfer - Apply to Lurasidone (Latuda) Project",

July 23, 2008. Global QA Meeting at USA.

6. "South America Depot GMP Audits and Control" and "Packaging Contractors

Evaluation and Selection", Dec. 4, 2008. Global QA Meeting at Osaka,

Japan.

7. "Preparing and Managing FDA Inspection", June 16 to 18, 2010, presented

to YGK for its preparation for an upcoming FDA PAI (Fukushima, Japan).

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