Development Quality

Lih-Yueh (Lisa) Hwang

** ******** **., **********, ** 07054 / Cell: 201-***-****; Home: 973-884-

**** / ***********@*****.***

ANALYTICAL LEAD

Solutions-focused, diligent Scientist with intensive CMC-Analytical

experience in the Pharmaceutical and Bio-tech industries for small and

large molecule entities. Calm demeanor in the face of difficulties;

ability to manage multiple projects while working under dynamic and

changing environments. Highly versatile; quickly masters new roles and

responsibilities. Reputation for integrity, perseverance, and work ethic.

Excellent interpersonal communication skills. Continuously pursues

opportunities to learn and takes on challenges for further professional

development and growth.

CORE COMPETENCIES

. Research & Development . Process Development / Validation .

Proactive Problem Solving

. Data compiling & Interpretation . Staff Training & Motivation .

Presentations & Reports

. CMC & RA Support

PROFESSIONAL EXPERIENCE

Sigma-Tau PharmaSource, Inc. (02/2011-Present)

Consultant

Maintain full accountability for handling all aspects of activities in

support of organizational goals and objectives. Apply dynamic strategic

planning, prioritization, and project management skills toward consistently

achieving critical deadlines while maintaining high quality standards.

Conduct detailed research and apply findings toward drafting, assessing,

and submitting validation protocols and reports for the biologics.

Selected Highlights:

. Played a key role in executing all facets of Quality Operations under

GLP/GMP environments, including assisting with experimental study

protocols, stability study protocols, analytical methodologies

transfer, validation reports, and response to audit issues.

. Diligently supported the product manufacturing by compiling analytical

data, monitoring release/stability data, and writing reports for the

CMC section to support for regulatory submission under the

ICH/USP/FDA/EMEA guidelines.

. Effective communication collaborated with different groups within and

outside of the company.

. Proficiently executed ongoing Technical support in OOS investigation

and problem solving.

Enzon Pharmaceutical Co., Piscataway, NJ

Senior Scientist (01/2006-01/2011)

Scientist III (12/2003-01/2006)

Strategically planned and coordinated research projects to ensure on-time,

requirements-compliant completion. Facilitated the integration of

analytical methods to CRO to support the product development and regulatory

submission. Demonstrated exceptional communication skills in representing

the Analytical Sciences Department and actively collaborated with PDL

(process development laboratory), RA, QA/QC, and CRO to successfully launch

the protein product (biologics). Designed, developed, and implemented

validated analytical methods to support product manufacturing, including in-

process samples, final product (Drug Substance, DS, and Drug Product, DP)

for release and stability testing. Applied strong research and analysis

skills to evaluate analytical data efficiently and to provide information

in supporting product development.

-Continued-

LIH-YUEH (LISA) HWANG, PAGE 2 Cell: 201-919-

1987;

Home: 973-***-****

PROFESSIONAL EXPERIENCE

-Continued-

Selected Highlights (at Enzon Pharmaceutical Co.):

. Researched new analytical methods, developed new assays, authored

multiple test methods, designed validation protocols, conducted the

method qualification/validation, and wrote and approved validation

reports and technical reports in eCTD format for regulatory (IND and

BLA) submission.

. Strong technical knowledge in troubleshooting: design and carry out

experiments to prove the root cause; condut forced degradation to

identify impurities/degradants by appropriate analytical techniques,

like UV, HPLC, UPLC, LC/MS, IC, and GC.

. Developed and optimized analytical methods for testing of drug

substance and drug products (in-process and finished product for

release and stability)

. Excellent team worker with strong communication skills as an

Analytical Representative on project teams (USP and DSP), coordinated

with Analytical activities, interpreted/compiled analytical data, and

delivered the analytical data to the team as well as updated the

progress to the management in effective timing.

. Collaborate with CRO and QC/QA for analytical methods transfer,

operation/process development for supporting prodcut development, RA

for validation/cGMP related documents and regulatory submission.

. Executed the validation work and the regulatory related job under cGMP

compliant environment and cGMP practice was followed.

Schering Plough Research Institute, Union, NJ

Scientist II (12/2000-12/2003)

Enhanced operational performance by integrating a diverse range of

analytical methods according to ICH Quality Guidelines and in-house SOPs in

compliance with GLP/GMP requirements. Teamed with Contract Research

Organization (CRO) to provide comprehensive technical support and to ensure

successful and timely filing.

Selected Highlights:

. Designed/performed complex analyses and evaluations, and applied the

assay, dissoution, and impurity methods for marketed products, solid

dosage (Tablets and capsules) and semi-solid dosage form (lotion, gel

and cream), using spectroscopic and RP-HPLC techniques.

. Delivered scientific support by evaluating technical/validation

reports in accordance with in-house SOPs and guideline (FDA, ICH, and

cGMP) requirements.

. Provided analytical support and coordinated with CRO for analytical

methods development/validation.

. On-site CRO visit to verify the quality of the CRO laboratory

regarding analytical/QC related tasks.

. Actively contributed to day-to-day management by coordinating meeting

to update the status of the responsible projects.

-Continued-

LIH-YUEH (LISA) HWANG, PAGE 3 Cell: 201-919-

1987;

Home: 973-***-****

Purepac Pharmaceutical Company - Elizabeth, NJ

Scientist I (01/1998-01/2000)-Scientist II (01/2000-12/2000)

Associate Scientist III (02/1994-01/1998)

Facilitated the coordination of the New Product Development (NPD) for

formulation optimization in manufacturing processes. Diligently utilized

various analytical methods in accordance with ICH/USP/FDA Quality

Guidelines and in-house SOPs. Conducted detailed method validations,

prepared analytical summary reports, and supported the method transfer to

the Quality Control (QC) Department.

EDUCATION

M.S. in Applied Chemistry B.S. in Pharmacy

New Jersey Institute of Technology, Kaohsiung Medical College, Taiwan

Newark NJ R.O.C

INSTRUMENTATION

. HPLC: Agilent 1100, Waters Alliance and Acquity (UPLC)

. Dissolution apparatus: Distek, basket and paddle

. Mass Spectrometer (MS): Agilent MSD; Waters SQD, Thermo LCQ, LXQ, and

LTQ; ABI Q-Trap 4000 and Voyager MALDI.

. Advanced computer Skills: excellent in Microsoft word, excel, and power

point; Waters Empower/Millenium;

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