Shahin Jamal

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

Jericho, NY ****3

631-***-****

abn0xv@r.postjobfree.com

Seek a career opportunity as a chemist in Research and Development lab

applying my expertise with chromatogrophy.

KEY QUALIFICATIONS:

An accomplished research scientist in an Analytical Department with a

Masters in Chemistry with over fifteen years of experience in Research and

Development

Expertise in method development, method validation, method transfer and

stability study in cGMP environment.

Experienced with residual solvent analysis in drug products headspace GC-

FID.

Experience on HPLC with UV/VIS, fluorescence, PDA detectors.

Hands-on experience with IC, FTIR, Karl Fisher and Malvern Particle size

analyzer.

Strong analytical skills and familiar with good understanding of cGMP

environment, ICH guidelines and FDA guidance.

Write and review methods, validation protocols, reports and SOPs.

Able to work independently and in a collaborative, team environment.

Ability to manage completing projects and troubleshooting

Recognized as a quick learner with sound scientific judgment, dedicated to

meet customer needs

WORK EXPERIENCE:

May 1998- present ENDO Pharmaceuticals, Inc., Westbury, NY 11590

Research Scientist

Responsibilities:

. Independently designed analytical studies, pursuing trends and

patterns found in scientific literature and data obtained through

studies and/or testing new techniques, equipment and methods.

. Developing analytical method (HPLC, IC, GC, FTIR, Dissolution, UPLC)

and performing method Validation in compliance with USP, FDA and cGMP

requirements and execute method transfer from R& D to QC Lab.

. Collaborated with other groups and departments during project

challenges

. Provide analytical support for formulation and collaborated during

drug development

. Provide product support such as release testing of clinical supplies,

analysis of cleaning verification samples, identity confirmation,

impurity quantitation by HPLC

. Work both independently and as a team member and manage multiple

projects/analyses

. Researching, planning, and designing experiments; coordinating

research projects and evaluating results.

. Providing regular updates and recommendations to senior management.

. Maintaining alignment with team and customers through all stages of

technology development.

. Planning, executing, and reporting on original studies or ongoing

studies to resolve new problems.

. Performing the full range of qualitative and quantitative chemical and

physical analyses on a variety of drugs (capsules, tables,

suppositories and patches etc).

. Interpreting and evaluating analytical results to determine their

validity and accuracy; and researching and devising new approaches to

problems when standard techniques are not applicable.

. Anticipate, identify and resolve customer needs, Strive for the

highest quality work product

. Drive results with a sense of urgency, focus on innovation and

continuous improvement

. Measure progress and results. Take responsibility for delivering

quality results in all aspects of job

. Stay current with new technologies and industry challenges. Continue

improving my technical skills.or coordinate manufacture's service for

repair, order parts, schedule for Preventive Maintenance and mainte

records for assigned analytical instruments

. Continue to support in developing robust and reproducible analytical

methods for testing the product.

. Support metrology sub team, continue to repair, assist to repair

. Strengthen general knowledge of generic drug development and industry

trends by attending conference and workshops, read journal

publications, professional magazines, attend free seminars or

webinars, and effectively use available resources.

. Consult for troubleshooting and resource needs

. Evaluate API quality and provide input to management. Support API

method transfer activities Finished Product.

. Perform dissolution of reference product in appropriate media, e.g.

different pH.

. Troubleshoot potential formulation issues, e.g. stability,

dissolution. -Perform method validation.-Write method validation

reports, method transfer protocol,

. Perform comparative dissolution with reference product. Write

dissolution comparison reports.

. Performed majority of the method development, validation, and API

method transfer and release activities.

. Maintain current status with instrument calibration needs and to

contact the Vendors so calibration is performed on time, maintain all

calibration records, and update instrument calibration status in LIMS.

. Attend all EDGAR related trainings to keep myself up to date with the

process.

Continuing improvement of cGMP and DEA in compliance with Analytical

operation where necessary

. Ensure that assigned job functions are properly handled, safety

violations are cited for the functional areas. Comply with DEA

regulations

. Attend scheduled SOPs trainings to comply with ENDO's cGMP operation.

Keep current with FDA and compendial guidelines as it applies to my

job function such as:

Timely and proper notebook documentation, Analytical Method

Compliance.

Proper labeling of glassware in the lab, Timely and proper Instrument

Maintenance.

Timely Instrument Calibration, Reference Standard Compliance, -SOP and

EOP compliance.

. Conduct literature search for new industrial challenges and new

technologies to support the development of an integrated generic

product process for a smooth development path to assure minimal delays

to reach our time line

. Follow The FDA document: "The new quality-by-design (QBD) approach to

focus on critical quality attributes related to chemistry,

formulation, and process design. Under quality by design,

manufacturing will depend on a risk-based approach linking attributes

and processes to product performance, safety, and efficacy."

1993 - 1998 Time Cap Lab, Inc. Farmingdale, NY

Senior Chemist, Analytical Lab

Responsibilities:

. Work directly with method Development for an accurate and precise and

rugged method of analysis for new products

. Responsible for the stability testing and method validation of

experimental and regular batches, extended release and immediate

release products.

. Responsibility includes proper documentation and CGMP conformance of

all testing. Scientific data and documentation reporting.

. Maintained all analysis testing and Stability records.

. Proficient with liquid chromatographic techniques, ultraviolet,

infrared spectroscopy techniques, ultraviolet, infrared spectroscopy

and titration method.

. Familiar with USP/NF and BP Methodologies.

. Execute HPLC analysis of Johnson & Johnson cosmetics including creams,

powders, lotions, and liquids in accordance with GMP

. Perform method validation for new analytical methods for Johnson &

Johnson cosmetic products

. Train new employees in using Empower software

1989 - 1992 Cary Industries, Inc., Danbury, CT

Chemist

Responsibilities:

. Responsibility includes synthesis of Organic Dyes

. Performed testing on dyes, using HPLC, UV ad IR spectroscopy, etc.

. Executed HPLC analysis of drug product in accordance with GLP

. Validated new analytical methods

. Assisted in HPLC method development for new formulations

. Extensively used Excel to tabulate and graph validation results

. Ensured high data and report quality in compliance with cGLP/GMP

requirements and department SOPs

. Coordinated with Formulary pharmacists for submission of samples for

maximum timeliness and efficiency

. Prepared for internal and external GLP Audits as well as responded to

internal audits

. Performed trace metal analysis of GMP drug product via ICP-OES

. Used Isolator/Glove box for preparation of oncology drug product

analysis

. Assisted in updating and improving drug safety support SOPs

. Maintained lab according to sanofi-aventis site safety regulations

1987 - 1988 Danbury Pharmaceuticals, Inc., Danbury, CT

Chemist 1987 _ 1988

Responsibilities:

. Performed analysis on finished products for Assay, content uniformity,

identification tests and dissolution testing following company's

monograph, USP/NF and BP

. Document all testing in Lab note book with cGLP/GMP requirements and

department SOPs

. Performed Hplc, UV/VIS, and IR analysis for the release of various

finished products

EDUCATION:

Masters in Chemistry AMU Aligarh, India

Bachelor in chemistry AMU Aligarh, India

HONORS and Organization:

Certify Training in CGMP

Certify Training in CGP

Certify Training in GLP, DEA, OOS, OSHA and EPA Regulations

Certify Training in Quality Assurance GMP

COMPUTER SKILLS: Proficient in Chemstation (Citrix), Empower, MS Word,

Excel, PowerPoint, Outlook

REFERENCES:

Furnished upon request

Contact this candidate