Summary
Overview
Work History
Education
Skills
Certification
Community Service
Personal Information
Timeline
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Alkesh Mistry

Morganville,NJ

Summary

Enthusiastic professional with 15+ years of experience in the biopharmaceutical industry. Excited about joining a new team in a fast-paced, high-volume environment. Expertise in quality data-driven analysis, known for being well-organized, independent, and detail-oriented. Strong believer in teamwork and effective time management. Strives to contribute to team success while maintaining excellent communication skills.

Overview

19
19
years of professional experience
1
1
Certification

Work History

Senior Chemist

UPM Pharmaceuticals INC.
08.2023 - 05.2024
  • Performed routine dissolution for small molecules using HPLC
  • Developed and validated HPLC methods for controlled substances and Non-Controlled ANDA products
  • Involved in HPLC Method Development and Method validation of Finished Product

Analytical Chemist

AIM Immuno Tech LLC.
01.2023 - 07.2023
  • Independently Developed analytical methods in a GLP environment for clinical compound Ampligen for using HPLC, Gel Permeation Chromatography SDS-PAGE, qPCR, ELISA for protein characterization and bioassay.
  • Performed analytical chemistry assays based on new and existing methodologies, operating analytical instrumentation such as HPLC, LC-MS, FTIR, UV

Analytical Chemist

Strides Pharma INC.
07.2022 - 12.2022
  • Actively participating in Method Validation using HPLC, GC for ANDA filing for various generic/brand drug products and API
  • De-formulation of Brand Products, Excipient Isolation, characterization, and quantitation by using HPLC, LC-MS, FT-IR.
  • Isolated and identified impurities from finished products and stability samples.

Quality Assurance Specialist

US Pharma Lab, LLC
05.2021 - 08.2022
  • Approving Master batch documents, product specification, equipment cleaning protocols and reports, process validation reports, and tech-transfer documentation as per 21 CFR 111 and 117
  • Manage change control requests and/or equipment utility change controls
  • Actively participating Non-Compliance Deviations, CAPA and Root Cause analysis
  • Handling actively and timely client/s quality related issues, Clients audits and inspections at Probiotic Mfg
  • Actively communicating with various departments for continuous improvement in streamline Process
  • Being a mentor (SME) to Six QA assistants for their training, monitoring in cGMP compliance activities

Research Scientist

BRISTOL-MYERS SQUIBB
07.2010 - 04.2018
  • Position eliminated during companywide workforce reduction
  • Responsible for aseptic process manufacturing and process validation at ISO 5- ISO 8 suits during five clinical trials for two branded oncology drugs
  • Utilized Isolators for aseptic processing and sterility testing
  • Responsible for aseptic process manufacturing and process validation at ISO 5- ISO 8 suits during five clinical trials for two branded oncology drugs
  • Expertise in Upscale production of (Monoclonal Antibodies)
  • Expertise with Global Material(s) supplies management and qualification SPEC (Creation and revision under cGMP) and budget using SAP
  • Worked with Italian and US suppliers for Sterile components for new and existing critical materials enrollment, qualification under quality agreement, Supplier complaints and change notifications
  • Expertise with QMS such as Compliance Wire, Track Wise, MasterControl, LIMS, and electronic Lab Notebook (ELN).
  • Integrating engineering and life sciences theories into the development of products
  • Re-evaluating process and identifying area of improvement
  • Creating reports and updating shareholders
  • Designed experimental plans, interpreted scientific results, summarized & presented data, and reported progress to Clinical Site Manager
  • Performed root cause analysis and corrective actions when necessary
  • Utilized in-depth understanding of cGMP, GLP, USP and ICH-guidelines, as well as multi-national biopharmaceutical regulations
  • Verified data related to method development and testing of GMP materials
  • Completed continuous improvement courses on statistical analysis for process development/validation
  • Collaborated with successful method transfer, training of Senior Scientists from Puerto Rico and Shanghai, China plant, accounting for cultural differences and language barriers to ensure understanding and agreement regarding manufacturing best practices in global locations
  • Responsible for quality assurance and timely revision of standard operating procedures (SOPs)
  • Worked successfully with team, as well as independently, in fast-paced environment
  • Trained new hires on laboratory best practices and process improvement opportunities
  • Techniques/areas of expertise: State-of-the-art Sterile filling for Parenteral Drug by Siemens Isolator, Aseptic Process Management, Change Control Management and Method Validation
  • Select Achievements / Projects Enhanced aseptic process filling results during clinical trial after identifying insufficient equipment (tubes, Vial), which resulted in lab negotiating contracts with new manufacturers in the Isolator

Research Scientist (Contract Assignment)

Johnson & Johnson Consumer Products
04.2008 - 04.2009
  • Collaborated with team in HPLC method development of known and unknown compounds for new consumer drug product for KY Jelly after worldwide documentation of adverse reactions
  • Diethyl Phthalate derivative in packaging after performing root cause analysis; successfully resolved major issue within seven months
  • Utilized Viscometer and HPLC for product analysis and characterization
  • Techniques/areas of expertise: Change Control, Product Improvement Management for Global Supply

Research Scientist (Contract Assignment)

Bristol-Myers Squibb
04.2007 - 03.2008
  • Performed development for design method and collaborated with team of chemists to develop analytical method for new oncology drug Lirilumab (BMS-986015) for Acute Myeloid Leukemia (AML)
  • Designed verification process to determine if use of biological compound produced desired results and was compliant with regulatory standards
  • Utilized multi-step organic synthesis to perform Blanc choro-methylation of aromatic compounds using zinc as catalyst
  • Verified successfully, which led to oncology drug Empliciti
  • Kept instruments in sound condition and troubleshot experimental issues and instrumental problems
  • Techniques/area of expertise: Protein Purification, Isolation and Analyzed on HPLC LIMS and ELN

Research Scientist (Contract Assignment)

Merck & Co, INC.
11.2006 - 03.2007
  • Served as Quality Control Chemist while supporting stability batches for NDA filling for oncology drug product using HPLC-analytical method
  • Monitored and documented changes that occurred during various stability stations (time and humidity points)
  • Successfully delivered project results on time and in compliance with FDA & cGMP regulations
  • Techniques/areas of expertise: HPLC analysis, LIMS and ELN

Scientist (Contract Assignment)

Janssen Pharmaceuticals
10.2005 - 11.2006
  • Responsible for stability testing of ~5 different products, including Risperdal, Topamax, Ortho-Tri-Cyclen, Ortho-Novum 7/7/7, and Levaquin
  • Performed analytical testing; utilized HPLC and dissolution testing of solid dosage unit stability lifecycles as per FDA regulations at cGMP lab
  • Techniques/areas of expertise: Stability Batches analysis, Compliance wire for out-of-Specification filing

Education

Bachelor of Science - Chemistry

Maharaja Sayajirao University Of Baroda
Vadodara

Master of Science - Bioengineering

Stevens Institute Of Technology
Hoboken, NJ
05.2019

Master of Science - Applied Chemistry

Maharaja Sayajirao University Of Baroda
Vadodara
07.1995

Skills

  • Analytical Assay Method Development & Validation
  • PAT
  • DoE
  • Biopharmaceutical Biological drug Development
  • Aseptic Process Development & Manufacturing
  • ISO 5-8
  • OSHA
  • CGMP
  • GLP
  • FDA Compliance
  • Project Management
  • Critical Materials Resource Management
  • Continuous Improvement
  • Molecular Genetics
  • Organic Chemistry
  • Statistical Method Analysis
  • Root Cause Analysis
  • Lyophilization Safety & Quality Standards
  • Clinical Trial Experience
  • Siemens Isolator
  • Autoclave
  • QRT-PCR
  • Western blotting
  • ELISA
  • Cloning Methods
  • MINIPREP
  • RNASEQ Library Prep
  • Oligonucleotide Synthesis
  • HPLC analysis
  • Cleaning Validation
  • Swab Testing
  • FT-IR
  • Raman Spectroscopy
  • Tissue Engineering
  • Aseptic Process Validation
  • USP
  • ICH Guidelines
  • Minitab18
  • Delta V
  • Waters Empower
  • LIMS
  • Velquest EPMC
  • ELN
  • SAP I/3
  • Microsoft Office
  • Bioinformatics

Certification

  • Currently pursuing specialized professional level certification in Applied Bioinformatics, University of San Diego, CA
  • Competent Leadership and Competent Communicator, Toastmasters International, Englewood, CO
  • Completed courses on statistical analysis for process development/validation, Stevens Institute

Community Service

  • Co-lead group of 8-10 backpackers on Appalachian trails in West Virginia, Vermont, and New York.
  • Information Volunteer at Appalachian Mountain Club (AMC), A Non-governmental Organization for protection, enjoyment and understanding of the outdoors.
  • Volunteer at the Special Olympics at the College of New Jersey, Ewing, NJ.
  • Certified Wilderness First Aid (WFA) and CPA specialist.

Personal Information

Citizenship: US Citizenship

Timeline

Senior Chemist

UPM Pharmaceuticals INC.
08.2023 - 05.2024

Analytical Chemist

AIM Immuno Tech LLC.
01.2023 - 07.2023

Analytical Chemist

Strides Pharma INC.
07.2022 - 12.2022

Quality Assurance Specialist

US Pharma Lab, LLC
05.2021 - 08.2022

Research Scientist

BRISTOL-MYERS SQUIBB
07.2010 - 04.2018

Research Scientist (Contract Assignment)

Johnson & Johnson Consumer Products
04.2008 - 04.2009

Research Scientist (Contract Assignment)

Bristol-Myers Squibb
04.2007 - 03.2008

Research Scientist (Contract Assignment)

Merck & Co, INC.
11.2006 - 03.2007

Scientist (Contract Assignment)

Janssen Pharmaceuticals
10.2005 - 11.2006

Master of Science - Bioengineering

Stevens Institute Of Technology

Bachelor of Science - Chemistry

Maharaja Sayajirao University Of Baroda

Master of Science - Applied Chemistry

Maharaja Sayajirao University Of Baroda

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Alkesh Mistry