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Senior Validation/QC Scientist

Vernon Hills, Illinois, 60061, United States
May 28, 2019

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

Vernon Hills, IL 60061

847-***-**** (cell)


Experienced QC Scientist/SME with over 15 year experience in pharmaceutical drug development/

manufacturing. Proven track record of analytical test method development, validation

and method transfer using RP-HPLC, UHPLC, CIEX, SEC, peptide mapping and UV/VIS for large

molecules qualification and approval of raw material, in-process and finished products and release

testing of sterile pharmaceutical products. Hands-on experience in writing and updating SOPs and

review of manufacturing batch records and Instruments qualifications for equipment IQ/OQ and

PQ. Experience in technical writing in relation to validation, verification protocols, reports and white

papers to comply with the current ICH approach on method validation. Possess a solid under-

standing of FDA/ICH guidelines, CFR 21 Part 11, cGMP/GLP, USP/EP/JP. Experience in electronic

data analysis and review (Empower) to ensure data integrity and audit trail follow up. Lead and

support research projects with excellent follow-through abilities to work with cross-functional teams.


As a SME to perform data review of products to ensure the in-house developed method is comparable to USP or other reference monographs. The methods are based on HPLC, GC, UV/VIS absorbance, titration assays, AA Spectrophotometry and Wet chemistry for product development and release.

As a validation team member, executed bio-analytical method validation utilizing RP-HPLC with SEC, CIEX, peptide mapping and Triton-X100 HPLC method for monoclonal/biosimilars.

Designed and performed test method development, test method validation/verification and method transfer studies.

Technical documents review and evaluation of CMC packages as part of regulatory/FDA submission

Providing expert review of analytical data, setting up acceptance criteria and specifications for raw material, In-Process, and finished products based on the methods and C of As, handling of out-of-specification (OOS) and developing action plans to meet sound scientific practices.

Team lead (SME) on remediation of test method validation of over 2500 test methods for continuous life cycle management program and to comply with current FDA/ICH/USP requirements.

Hands-on experience on gap assessment, validation and verification protocols and reports, SOPs, root cause analysis, and CAPA to facilitate remediation process in a timely manner.



A leading In Vitro Diagnostic company specializing in IVD assays for early stage Cancer Detection

IVD Test Method Validation Engineer

As a Bio-analytical Test Method Validation SME, design the validation studies based on FDA and ICH guidelines

Working as an IVD Test method Validation Engineer supporting 25+ Test method Validations for an IVD/Diagnostics company

Review SOPs, writing Test Method Validation Protocols, their approval and training various lab personnel for the execution

Review execution records to ensure the complete validation, writing validation reports for their approval

PHARMEDIUM, LLC MEMPHIS (RCA Consulting) Mar 2018-Jun 2018

A leading pharmacy compounding specializing in compounding of opioids under aseptic processing

Consultant- Training and Investigation SME

Working as a compliant monitor to review and investigate OOS, OOT, open CAPAs (using Fish-Bone analysis) and data Integrity in compliance to FDA guidelines.

Review of batch records, manufacturing operation issues leading to OOL and aseptic processing monitoring for any contamination

Review of laboratory investigation/operation to monitor any systemic issues with compliance.


A leading global contract manufacturing company specializing in health care devices and products

Test Method Transfer Team Member

Designed and carried out bio-analytical test method development, validation and method transfers from clients/originating laboratories to Cook Pharmica for the production of the drug products. This involved SEC, CIEX, Peptide Mapping, Polysorbate-20 and ELISA based methods for biologics/monoclonal antibodies.

Performed in-process, on-demand and release product testing for various clients.

Trained chemists to perform in-process and on-demand samples testing following method transfer of the validated methods.

PATHEON, FERENTINO, ITALY (Validant Consulting) May 2016-Aug 2016

A global contract pharmaceutical company focusing on sterile manufacturing and development of biopharmaceuticals and small molecules.

Analytical (Chemical) Test Data Review (SME)

As part of third party (independent) consultant, involved in reviews of operations in commercial and product development services and laboratory based test data for manufacturing to ensure the data integrity, consistency, accuracy and completeness.

Responsible for analytical data review of HPLC, GC, UV/VIS, and IR to comply with FDA/GMP guidelines and their approval process prior to batch release.

Assessment of laboratory practices and testing in real time in the labs to oversight testing activities, ensuring procedures and GMP/GLP are being followed with defined guidelines.

Review of electronic data for raw material, in-process and finished products for data handling, recording and integrity and back-up storage.

Responsible for providing feedback/training/coaching to the site based on the observations and findings following the review process.

INTARCIA, MENLO PARK, CA (Validant Consulting) Dec 2015-Apr 2016

A CMO manufacturing and testing biological active peptides for clinical trials

Analytical Test Method Review (SME)

Team Lead (SME) involved in raw material in-process, finished products and their release testing for product manufacturing and analytical test methods program ensuring compliance with FDA guidelines for validation. Developing and executing analytical test methods for raw material, in-process and finished products for NDA filing. Review of DMF, Batch records and final release testing.

Review of electronic analytical data (Empower) for HPLC, writing protocols, reports and their approval for analytical methods involving raw material, in-process and finished products and their release testing.

Review of testing methodologies for routine chemical tests.

Review of batch records to ensure correctness and data integrity.

MYLAN INDUSTRIES, INDIA (Validant Consulting) Oct 2015-Nov 2015

A generic pharmaceutical company specializing in manufacturing generic drugs and topical solutions

Analytical Compliance Consultant

Team member leading to Laboratory Investigation (LIR) and Manufacturing Investigation (MIR) on Out-of Specification (OOS) results as part of Remediation Action Plan to ensure compliance to FDA.

Review of LIR and MIR reports to investigate OOS observed in raw material, in-process and finished products of various products developed and marketed by Mylan, an Indian subsidiary of Mylan, USA.

Performed Impact Assessment and developed Action Plans to remediate the root cause of failure and recommendations through CAPA to implement and track the changes.

Root Cause analysis of OOS/deviation to investigate the cause and non-conformance.


A leading international pharmaceutical company based in Toronto, Canada

Analytical Compliance Consultant (Paraxel/Oxford International)

As a management consultant to work closely with the client on the following aspects:

Review historical Empower 2 and Empower 3 HPLC Data and classification of sample analysis in support of remediation and analytical compliance.

Perform manual calculations when necessary to ensure the integrity of the data.

HOSPIRA, INC, Lake Forest, IL (Consultant) Feb 2013-Dec 2014

A leading biotechnological company specializing in hospital products and manufacturing bio-generic drugs

Chemistry Analytical and Physical Methods Team Principal

Leading a team of scientists on remediation analytical test methods to comply with FDA/ICH guidelines as part of second phase of which involved:

Remediation of validation gaps that were identified during assessment phase.

Based on Hospira internal guidelines, ICH recommendations and USP (Compendia), drafting White Papers to resolve the identified gaps.

Draft and Technical review of over 600 white papers dealing with validation parameters remediation.

Identifying the test methods that require full and/or partial validation, review of validation protocols and reports to successful completion of method validation.

Key member of remediation team performing and reviewing gap assessment of over 2500 chemistry test methods used in drug product development. This includes review of each test method (compendia) with product list associated with the product to ensure the method is comparable to USP or other reference monographs. The methods are based on HPLC, GC, UV/VIS absorbance, titration assays, AA Spectrophotometry and other analytical methods for product development and release.

Supervising a large number (25) of chemists on remediation activities.

MEDLINE INDUSTRIES, INC, Mundelein, IL Apr 2010-Jan 2013

A medical device privately owned company specializing in pharmaceuticals and medical devices

R&D Project Scientist/Validation/Medical Device

Responsible for setting up a new R&D Division, supervising new analytical lab for method development, feasibility studies to assign specifications and validation for new drug products, managing stability program for shelf life in US and EU market. Principally involved in submission and approval of two (2) 510K for drug/device combinations and worked on submission of three (3) additional 510K in the last two years.

Led Medline stability program for shelf life dating of over 200 products that include, drug-device combination, drugs and devices alone for US and EU marketing.

ROCHE DIAGNOSTICS, Indianapolis, IN Jun 2007-Mar 2010

Roche is a leading healthcare company with a uniquely broad spectrum of innovative solutions

Senior Validation Scientist/Regulatory Affairs

Key team member for the analytical test methods program ensuring compliance with FDA guidelines for validation. Interacted with cross-functional team involving Regulatory Affairs, Quality Control, Manufacturing and Production staff.

Completed successfully analytical test method validation project to ensure FDA compliance.

Evaluation of scientific data, setting up acceptance criteria and specifications based on the method, out-of-specification (OOS) and developed action plans to meet sound scientific practices.

Execution of approved validation protocols and revalidation of analytical test methods and process validation as per ICH guidelines and requirements for both in process and final process products.

HOSPIRA, INC/ABBOTT LABS, Lake Forest, IL Jan 2002-May 2007

A leading biotechnological company specializing in hospital products and manufacturing biogeneric drugs

Validation Scientist/Senior Technical Specialist

Key team member supporting continuous improvement activities for the validation program to ensure efficiency, effectiveness and compliance

Established validation program for newly formed company by completing 25% (250/1000) validation of physical test methods used for medical devices.

Participated in multiple cross-functional project teams by representing Validation group for Product development and provided advice on validation requirements as needed.


Ph.D., Biochemistry, Aligarh Muslim University, India

B.Sc., Chemistry, (Dean’s Merit List), Lucknow University, India


American Association of Pharmaceutical Scientists (AAPS)

American Society of Test Methods (ASTM)

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