Quality Control Development
Resume:
PRADIPKUMAR C. PANCHAL
Contact: 312-***-****
*****************@*****.***
• Professional Summary:
17+ years experience in regulated pharmaceutical industry for Analytical method development &
Validation including Quality control compliance for all kind of pharmaceutical dosage forms.
Skill & Experience summary:
Provide specific and cost effective analytical support subject to DMF submission for F&D project
considering Quality of product in accordance with FDA and ICH guidelines.
Leading the overall scientific, technical and operational efforts of the Analytical Development department
with analytical characterization, development/validation of analytical methods, specification
development, release and stability testing and technology transfers that enables small molecule drug
substance and drug product manufacturing process and product development to meet global clinical
development needs.
Provide strategic and technical leadership to analytical development scientists and technical staff
responsible for analytical characterizations, method development, validation, release and stability
testing/reporting and specification development to support pharmaceutical molecule drug substance and
drug product manufacturing process and product development including clinical, commercial and life-
cycle development program.
As a member of the Pharmaceutical Development Leadership Team, work collaboratively with all other
pharmaceutical development functions and Pharmaceutical Development Compound Leaders and
contribute extensively to cross-functional program strategy, product development plans, timelines and
oversight of the compound teams executing those plans.
Serve as a key strategic member of the Pharmaceutical Development leadership team by continually
assessing functional capabilities and processes and provides guidance for best practices and direction for
continuous improvement.
In cooperation with Medicinal Chemistry synthesis dept leaders, lead analytical science capabilities to
enable the product and process development activities for medicinal compounds to ensure development
are advanced to meet global project requirements and corporate objectives.
Apply scientifically-driven strategic thinking and encourage the development of scientifically sound, well
understood and robust manufacturing processes during the development and scale-up phases.
Provide input to the drug product development strategy, budgets, timelines that helps scientifically and
met business expectations.
Review quality-related sections in CMC sections of ANDA filings and addresses inquiries from
regulatory agencies for analytical support.
Expertise in project activity in accordance with FDA, ICH, and IP / BP / EP / USP Pharmacopeias with
cGMP regulation.
Experienced in execution project of Drug substance & all kind of Drug product technology like Tablet
(IR & MR)/ Capsule / Injectable / Dry syrup /Eye-Ear drops /Oral Liquid / Suspension / Ointment of
F&D project on time providing analytical test method for each stage, Validation, Technology Transfer as
per Regulatory requirement for Quality control Laboratory.
Analytical support to CRO for bio-equivalence study for ANDA product and accountable for technology
transfer to internal manufacturing sites and external CMOs
Proficient in method development in separation techniques like HPLC/TLC and others like UV-
spectroscopy / fluorometry /AAS for elementary analysis and chemical analysis.
Expertise in operating and troubleshooting different make of HPLC/GC (Waters / Agilent / Shimadzu),
Dissolution test (Electrolab / Varien) for routine use.
Knowledge of Standard Operating Procedures, Laboratory Procedures, USP regulations, Analytical
Testing Techniques.
Experienced in Impurity qualification / purification / structure elucidation by NMR/ MASS, fraction
collection, and other techniques.
Review / approval analytical data for Generic product filing for method validation, stress testing /
Excipient compatibility / Solubility / Technology transfer / Regulated quarries.
Review of product specification, standard test procedures (SOP), technology transfer reports, and
investigation summary reports.
Organize analytical laboratory investigation & take corrective action plans in analytical method issues & manage
routine department activities and complex quality issues.
Excellent written verbal communication, interpersonal, management skill, strong work ethic, gathering,
organizational skill.
Expertise in complex data analysis review and preparation of technical reports /summaries from
validation studies.
Excellent at negotiating, influencing and managing partner and contractor relationships.
Demonstrated situational leadership skills like teambuilding, facilitation, conflict resolution, persuasion,
negotiation.
Accurate, detailed oriented, team focused, and possess the ability to complete multi-task in a fast paced, high
output environment.
Working collaboratively with internal stakeholders, external research partners and third party service
providers.
Ensure overall laboratory readiness for regulatory inspections and internal audits.
To encourage and support the technical and career growth of personnel.
Professional Experience :
Senior Manager-ADL: Gowrie Research Pvt. Ltd. (B&S Group-UK)-Vadodara India
[01/11/ 2013 – 08/17/2013]
Major responsibilities:
• Timely execution of F&D projects for Europe market by supporting analytical aspect for ANDA
submission.
• Leading analytical scientist team & guide them for completion of the task in timely manner.
• Reviewing data for analytical method development / Stability study / Validation / Technology Transfer /
excipient compatibility / Stress testing for different kind of dosage forms & API.
• Provide validation document for analytical method to Quality control for In-process, Finished product &
Stability testing using HPLC, GC, Dissolution tester & other instruments.
• Analytical support to Regulatory affairs & Quality control department.
• Project planning & procurement as per project requirement.
• Monitoring the laboratory activities according to GLP.
Manager-ADL: J B Chemicals & Pharmaceuticals Ltd; Panoli-India [07/04/ 2011– 01/10/2013]
Major Responsibilities:
• Timely execution of F&D projects for Europe & USA, other market by supporting analytical aspect.
• Leading the analytical method development activities for routine quality control testing for Solid oral
dosage forms, Liquid, Ointment, Eye / Ear drops, Injectables and validation for the same by HPLC,GC,
spectrophotometry or using appropriate instrument.
Leading the analytical scientist team & Guide them for completion of the task in timely manner.
•
Reviewing data for Analytical method Development / Stability / Validation / Technology Transfer /
•
excipient compatibility / Stress Testing for different kind of dosage forms & API.
Analytical Support to Regulatory affairs & Quality Control.
•
Project planning & procurement as per project requirement.
•
Monitoring the laboratory activities according to GLP.
•
Troubleshooting in day to day activities.
•
Scientist-II (Executive)–ADL: Torrent Research Centre; Ahmedabad-India
[11/06/ 2006 – 06/30/ 2011]
Responsibilities:
• Analytical method development / Validation / Technology Transfer for ANDA products for solid oral
dosage forms like Tablets / Capsules and API.
Development of Analytical method for Dissolution, Assay, Related substances, Content uniformity, Blend
•
Uniformity & different stages of reaction monitoring of API synthesis.
Calibration of HPLC, GC, Spectrophotometer, Dissolution tester pH meter.
•
DMF review of API & working on Technology transfer Product.
•
Analysis & Technical data review for Analytical method Development / Stability Study / Validation /
•
Technology Transfer / excipient compatibility / Stress Testing for different kind of dosage forms &
API.
Development of Mass spectroscopy method for Identification / Qualification of impurity characterization.
•
Analytical Support to Regulatory affairs & Quality Control.
•
Training junior scientist & guide them for completion of the task in time.
•
Project planning & procurement as per project requirement
•
Jr. Research Associate–ADL:Cadila Healthcare Ltd.; Ahmedabad-India
[08/12/ 2004 –10/31/ 2006]
(ZYDUS CADILA)
Responsibilities:
• Development of Analytical method for Dissolution, Assay, Related substances, Content uniformity, Blend
uniformity for routine Quality Control testing for Solid oral dosage forms like Tablets & Capsule for
ANDA submission.
Analysis & Reviewing data for Analytical method development / Stability study / Validation /
•
Technology Transfer / excipient compatibility / Stress Testing for different kind of dosage forms &
API.
Dossier review of API & Technology transfer Product.
•
Project planning & procurement as per project requirement.
•
Training junior scientist.
•
Jr. Officer-Quality Control Lab: Alembic Ltd; Vadodara-India [09/01/1996 – 08/07/ 2004]
Responsibilities:
• Analysis of different kind of dosage form like tablets, capsule, syrup, injectable, Hematinic formulation,
raw material as per STP/ Pharmacopoeia.
• Analysis of different types of water like raw water, potable water, water for injection, water for cooling
tower.
• Analysis of different types of macrolides and penicillin and Cephalosphorin derivatives.
• Experienced in pyrogen testing.
Additional Information:
• Education :
M Sc. - Chemistry - Guru Ghasidas University –India (2007)
[US equivalents Master’s in Chemistry- GPA 3.71 ]
B Sc. – Chemistry - Gujarat University – India (1995)
[US equivalents Bachelor’s in Chemistry- GPA 3.12 ]
• Software & Computer knowledge :
Empower of Waters, Class LC-10, Class-LC10vp, GC-17A, Agilent Open-lab.
Microsoft word, Excel, power point etc.
• Personnel :
Sex : Male
: 12th November 1974
Date of Birth
Nationality : Indian
Visa Status : F2I (Green card Holder –Legally authorized to work for any employer in
USA)
Languages Known : English, Gujarati, Hindi
Marital Status : Married
Native place : Nadiad- Gujarat-India
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