Summary
Overview
Work History
Education
Skills
Affiliations
Accomplishments
Software
Work Availability
Timeline
Volunteer

Manoj Shukla

Biophrmaceutical Clinical Research
Navi Mumbai,Maharashtra

Summary

  • Biophrmaceutical &Bioanalytical & Clinical research mangement Expert
  • Experienced vice president with over 20 years of experience in Clinical research in CRO and Pharmaceutical. Excellent reputation for resolving problems, improving customer satisfaction, and driving overall operational improvements. Consistently saved costs while increasing profits.. Possess unique set of knowledge and skills which includes in-depth understanding of business processes, business development and operational management at floor and strategic level.
  • 2000 plus methods expert in critical (low Pg,stabiity issue, chiral ,derivitisation)and Large Molecules MAb and in-vitro.
  • Handled more than 100000 billable samples with Method and validation activities by using 36 LC-MS/MS/108 staff.
  • Lab setup Lambda Ahmedabad,Lambada Canada,Panexcell.
  • Set up for typical formulation e.g. Injectables,Inhalers,Transdermal patches,Ointments & Creams, critical study for safety Fingolimid

Overview

1
1
Language
4
4
years of post-secondary education
23
23
years of professional experience

Work History

Vice President of Operations

Panexcell clinical Pvt. Ltd
Navi Mumbai, Maharashtra
09.2017 - Current
  • Panexcell clinical lab Pvt. Ltd, Mumbai Reporting to Managing director.
  • Devised, deployed and monitored processes to boost long-term business success and increase profit levels 35%.
  • Developed and implemented high-quality work environment as measured through employee satisfaction ratings.
  • Built loyal account base and long-term business relationships with international and domestic accounts.
  • Supervised 180 employees , overseeing efficiency of Clinical and Bioanalytical
  • Create simple system by SOP"s modification, Training of staff to meet sponsor expectation and regulatory requirement.
  • Observed each employee's individual strengths and initiated mentoring program to improve areas of weakness.
  • Improved productivity and operational costs by 10%.
  • 12 CR to 36 CR of CRO SBU turn over within period of 2.5Year with 35 % profit ratio.
  • Capacity of 800 dosing (82 bed) and 20000 billable samples (10LC-MS/MS)
  • Applied excellent problem-solving, process development and strategic implementation skills to lead and support all areas of operations.
  • Project management team and intra department coordination,after analysis completion 12 day for first draft report.
  • Implantation of QC department and reporting to management for streamline and online process.

General Manager-Head Bioanalytical

Lambda Therapeutic Research Ltd
Ahmedabad, Gujarat
03.2013 - 09.2017
  • Over all operation of bioanalytical
  • Regulatory Inspections; successfully faced Audits/Inspections-ASMPS Spain [1]; DEC 2017; WHO [1]; JULY 2018; DCGI [1]; 2017 & 2018; USFDA [1]; 2018, Ahmedabad Reporting to management.
  • General Manager – Head BA and Canada BA lab as additional role Department of Lambda Therapeutic Research, Leading 150+ staff (08 study director +140 bioanalytical scientist and support staff).
  • Overall Business Head of bioanalytical and Responsible for scientific, regulatory and financial performance of bioanalytical –Bioanalytical Lab.
  • Planning, organizing and supervising BA operations from strategic front in compliance with QMS, GCP/GLP and recent international practices.
  • In-vitro BE studies,PD studies e.g Orlistate on FTIR
  • Under supervision first GLP certified bioanalytical lab in India 2015.
  • Supervising team of Large molecule quantification E.g FSH,Mab
  • Responsible for budget and financial planning for Bioanalytical 100 CR.
  • Regulatory Inspections; successfully faced Audits/Inspections-and close all audit with response by appropriate CAPA.MHRA [1]; AGES [1]; ANVISA [4]; (Canada); USFDA [4]; pre GLP and GLP certification
  • Delivered business strategy and developed systems and procedures to improve operational quality and team efficiency
  • Managed budget implementations, employee reviews, training, schedules and contract negotiations.
  • Evaluated and enhanced Critical molecules method development programs to strengthen operations and achieve efficiency.
  • Streamlined office operations through clear role and JD and weekly task assignment , realizing significant improvements in productivity in samples analysis.
  • More than 100000 billable sample with 5-6 MD per month and capacity of BA lab.
  • FTF study report submission within 03 days after clinical completion.
  • Improved productivity with occupancy on LC-MS/MS (24*7) and vendor renegotiation ,optimization and operational costs by 10%.

Head of Bioanalytical

CRO – Lambda Therapeutic Research Inc
Toronto, Canada, ON
09.2011 - 03.2013
  • Managing Director – Lambda India.
  • Overall Business Head of BA and Responsible for scientific, regulatory and financial performance of CRO – Clinical Research, BA/BE, Bioanalytical Lab, PK & Statistics, QA and Project Outsourcing.
  • As Head-BA; Planning, organizing and supervising CRO operations from strategic front in compliance with QMS, GCP/GLP and recent international practices.
  • Lab renovation from scratch from regulatory and safety perspective and directly deal with Canada government permission for lab renovation.
  • Successfully get permission from Canada Government within short period and get successful inspection after renovation from different inspectors.
  • Evaluation of vendor and completed renovation with time frame.
  • Staff recruitment and training of staff.
  • GLP Certification for bioanalytical lab from health Canada.
  • Globalization of major system SOP’s and implementation of property software running at Lambda India.
  • Led product development efforts and key decision maker from bio-front for ANDA programs.
  • Tackled in-vitro & in-vivo BE studies including study state for modified release products.
  • Supervise and lead a group of 25+ professionals.
  • Responsible for budget and financial planning for BA.

CRO

Lambda Therapeutic Research Ltd
01.2007 - 09.2011
  • Ahmedabad.
  • Reporting to Head-Bioanalytical and then at later stage to Head-CRO.
  • In-charge, Bioanalytical, and at later stage operation as Head-Bioanalytical.
  • First lab in India which has implemented & used Bizet software for paper less sample chain of custody.
  • Reportees: Research Associates, Scientists &Study directors.
  • Key person in setting up the CRO for BA/BE studies at Lambda House.
  • Conducted first Experiment of Lab using LC-/MS/MS at Lambda House.
  • CRO Representative for QMS, Training, Safety & Disaster Management.
  • Established Quality Management System for CRO.
  • Laboratory Management & Supervision.
  • Worked Equipment Validation (IQ, OQ & PQ) – In-charge for CRO.
  • Method Development, Validation & Study Sample Analysis.
  • Operation, Calibration and Maintenance of HPLC & LC/MS/MS.
  • Prepare & review documents – General SOPs, Dept.
  • SOPs, Protocols, Schedules (Equipment & Training) & BE Reports.
  • Responsible for Manage and Lead Audits – Regulatory & Client’s.
  • Manage visitors, clients and auditors.
  • Handled the Clinical Trials of Biosimilar e.g.
  • G-CSF, EPO etc.
  • Specialized in derivatization of molecule and Fat analysis using FTIR.
  • Member of Lambda House Committee: Scientific & Strategic group responsible for set up lab at Lambda house, Research Efforts & Lab transfer plans in Lambda house.
  • Responsible for scientific & financial performance of CRO-Pre-clinical, Bioequivalence Centre, Bioanalytical Lab, Project Outsourcing & Business Development.
  • Led product development efforts and key decision maker for ANDA programs from Bio-front.
  • Supervise and lead a group of 40+ professionals.
  • Managed BA/BE and Clinical Trials for submission to different regulatory agencies including USFDA, Canada and ANVISA.
  • Responsible for project & resource management, and long-term planning for all projects.
  • Responsible for budget and financial planning for the operational groups.
  • Responsible for Quality Management in CRO.
  • Regulatory Inspections; successfully faced Inspections-DCGI [1]; Jun2011, ISO [1]; Nov2011 and WHO [1]; Mar2012.
  • Bringing and implementing scientific, quality, regulatory, managerial and leadership updates.
  • Responsible for bringing & retaining the manpower, and managing the performance appraisal of CRO personnel.
  • Pivotal in reduction of cost while at the same time smoothening the overall functioning of process with desired quality.
  • Reduced the data duplicity as well as streamlined the document procedure more effectively.
  • Received accreditation for effective team management and higher productivity without compromise on quality.
  • Significant Highlights:.
  • Conceptualized, Created & Run a CRO/ Drug discovery bioanalytical and analytical from scratch.
  • Built infrastructure, Team, Culture and Organization.
  • Under my Leadership, Lambda Lab has become the first Bioanalytical lab of India which cleared USFDA inspection without 483 first time in Asia twice, and grabbed bioanalytical work from top 25 MNCs.
  • No critical findings received from ANVISA, MHRA, WHO & USFDA till last day of my working at Lambda.
  • Worked as Project Leader for top 5 MNCs.
  • Started operations with a team of 25 professionals, reached to 150.
  • Win award for best performance twice in LAMBDA.

Certified LC-MS/MS Operator and Trainer, certified

AB Sciex
Foster City, Chicago, Chicago, USA, Chicago, USA, Chicago, USA, Chicago, USA, Sanfrancisco, Illinois, Illinois, Illinois, Illinois, Illinois
02.2007 - 03.2007
  • Revenue goal settings, Business Plans, Strategic initiatives.
  • Handling Domestic sales as well as International Markets like the US, EU, Latin America and the ROW.
  • Data based and good relation with clients.
  • Skilled in designing human pharmacokinetic studies for different formulation and regulatory.
  • Adequately exposed for CRO, BA/BE, Clinical Research, GCP & GLP, PK & Stat., QMS, QA, Training, Business Development, HR, Admin and Finance.
  • Successfully, led many regulatory inspections: USFDA , WHO, EMEA ANVISA , NPRA , MHRA , DCGI , CAP , NABL , GLP (Thailand),GLP ( OECD) & Clients (300+).
  • Key player in creating and operating 03 leading Indian CROs – Lambda Therapeutic Research Ltd, Ahmedabad India, Lambda Therapeutic Research Ltd.
  • Toronto, Canada & Panexcell clinical Pvt.
  • Ltd.
  • Mumbai India.
  • As ‘Key executive’, responsible to make scientific and strategic decisions for CRO business.
  • Lead product development efforts and key decision maker for ANDA programs from Bio-front.
  • Handled 3500+ Bioequivalence studies plus around ten CT phase I to IV studies (1500 Pilot & 2000 Pivotal) and 900+ Pharmaceutical Molecules including 20+ NMEs.
  • 50+ Research Articles, all published in International Journals e.g.
  • Bioanalysis, RCM, JCB, JPBA, JCS etc.
  • Presented 30+ invited talks to various international and national conferences/workshops.
  • Chair-Regulated Bioanalysis, CPHI Mumbai 2012 and Organizing Committee and Panel member for CPHI India.
  • Invited Speaker for CPHI Conferences, Spinco; Thermo Scientific; Pharma Edge, Mumbai; Gujarat Univ., Chitkara Univ., and Jiwaji Univ., India.
  • External Examiner & Co-Guide (industry) for M.Phil.
  • MS students at various universities and institutes.
  • As a CRO Expert, holds the distinction of:.
  • Professional Research Exposure: (Human Pharmacology & Animal)–BA/BE, Discovery & Regulated Bioanalysis, Clinical Trials, Project Management (CT phase ,Pre-clinical & Biotech), PK & Statistics, Quality Assurance and Business Development for CRO (Pre-clinical & Clinical and Bioanalysis).
  • As ‘Key executive’, responsible to make scientific and strategic decisions for CRO business.
  • Handled business worth of INR 100 Cr at Lambda (Bioanalytical) & INR 50Cr at Panexcell CROs.
  • Business orientation & closely associated with international Sponsors/Pharma including top 5 global Pharma.
  • Study Director/Principal Contact for 2 of the top 5 global pharmaceutical companies at Lambda.
  • Bioanalytical, Analytical and Pharmacokinetic Scientist expert with 20+ years of industry experience.
  • Present assignment, Head- CRO- BA/BE/CT Operations (Vice President), Panexcell clinical Pvt.
  • Ltd., Mumbai.
  • In recent past, worked as Head bioanalytical - Lambda Therapeutic Research Inc., Toronto Canada and Ahmedabad.
  • Exposed to: Drug metabolism and pharmacokinetics, Analytical & Bioanalytical, BA/BE, Clinics, Vaccine Trials, PK & Stat., QA, QMS, GLP-GCP, Training and Business Development.
  • Bioanalytical, BA/BE/CT, GCLP, GLP, GCP, QMS and QA Adviser., Santosh Maurya, Manoj Shukla, Wishu Shrivastava, Koteshwara Mudigonda, Vishwottam Kandikere, Ramakrishna Nirogi, "Quantification of Formoterol in human plasma by liquid chromatography - tandem mass spectrometry - application to a clinical study", 58th Pittsburgh Conference on Analytical Chemistry and Applied Spectroscopy, Wishu Shrivastava, Manoj Shukla, Santosh Maurya, Koteshwara Mudigonda , Vishwottam Kandikere, Ramakrishna Nirogi, LC/MS/MS electrospray ionization method for the quantification of Pramipexole in human plasma: Method validation and application to a pharmacokinetic study, 58th Pittsburgh Conference on Analytical Chemistry and Applied Spectroscopy, Manoj Shukla, Santosh Maurya, Wishu Shriavastava, Koteshwara Mudigonda, Vishwottam Kandikere, Ramakrishna Nirogi Liquid chromatography positive electrospray tandem mass spectrometry method for the quantification of Sibutramine in human plasma: Application to a bioequivalence study, 58th Pittsburgh Conference on Analytical Chemistry and Applied Spectroscopy, Wishu Shrivastava, Santosh Maurya, Manoj Shukla, Koteshwara Mudigonda, Vishwottam Kandikere, Ramakrishna Nirogi, Quantification of Tegaserod in Human plasma by LC/MS/MS using liquid-liquid extraction: application to a pharmacokinetic study, 58th Pittsburgh Conference on Analytical Chemistry and Applied Spectroscopy, Santosh Maurya, Manoj Shukla, Wishu Shriavastava, Koteshwara Mudigonda, Vishwottam Kandikere, Ramakrishna Nirogi, Quantification of Donepezil and 6-desmethyldonepezil in plasma by LC/MS/MS to support pharmacokinetic studies, 58th Pittsburgh Conference on Analytical Chemistry and Applied Spectroscopy, Manoj Shukla, Vishwottam Kandikere, Koteshwara Mudigonda, Devender Ajjala, Ramakrishna Nirogi, "Validated HPLC Method for the Quantification Of Oxcarbazepine and Its Active Metabolite 10-Hydroxycarbazepine in Human Plasma", in 2006 AAPS Annual Meeting and Exposition during.

PROJECT MANAGER

08.2002 - 01.2007
  • With Suven Life sciences LTD., Hyderabad as In-charge bioanalytical and analytical to support drug discovery program.
  • Set up state of art Bioanalytical and Biopharmaceutical Research lab and analytical lab (Installation, operation maintenance of LC-MS/MS, HPLC with UV, FL& ECD).
  • System /SOP established to meet the current regulatory and industry practices from ground label.
  • Leading, motivating and mentoring team of 30 researchers in Preclinical PK, In-vitro & In-vivo Metabolism, In-vivo Receptor Occupancy, Bioanalysis (Regulated and Discovery), Translational Research, Biomarkers & Brain Micro dialysis coordinate with client, plans manage for bioanalytical project.
  • Coordinate with Preclinical team for PK profiling of NCE’S.
  • Lab management for resources, review data and report preparation.
  • Metabolite identification, impurity profiling as part of basic research of NCS’s.
  • Design, conduct, manage and evaluate in vivo pharmacokinetic studies in rats, mice and rabbits for New Chemical Entities with appropriate SOP’s and regulatory guidelines.
  • Pharmacokinetic profiling of “Hits” and ‘Leads” in parental and non-parental routes.
  • Studies also include multiple doses, role of vehicles employed in dosing, species etc., toxic kinetic study design, conduct and evaluation of “Hits”.
  • Tissue distribution studies for New Chemical Entities in mice and rates.
  • Method development, validation, subject sample analysis for drug and/its metabolite/s (using {API/APCI)} LC-MS/MS.
  • ADME-PK-TK-Bioanalytics, driving small molecule drug discovery efforts for Suven and Many Global pharmacy.
  • Design of experimental approaches, providing expertise to cross-functional project teams, implement new technology platforms, for research services: Interact, accelerate and add value to discovery projects for Pharmaceutical Research Clients from US and Europe.
  • Coordinate with client, plans manage for bioanalytical project.
  • Coordinate with Preclinical team for PK profiling of NCE’S.
  • Lab management for resources, review data and report preparation.
  • Reporting to Group Managing Director for different assignments, and overall performance of BA and member management team.
  • Significant Highlights:.
  • Conceptualized, Created & Run a CRO/ Drug discovery bioanalytical and analytical from scratch.
  • Built infrastructure, Team, Culture and Organization.
  • Worked as Project Leader for top 5 MNCs.
  • Started operations with a team of 02 professionals, reached to 35 lead a team of 35 professionals.
  • Win award for best performance twice in consecutive year and promoted.

Ahmedabad Scientist

07.1999 - 09.2004
  • Reporting to Head-Bioanalytical/DMPK.
  • Key person in setting up the BA lab.
  • Conducted first Experiment of Lab using HPLC / LC-/MS/MS.
  • Established Quality Management System for Discovery lab.
  • Laboratory Management & Supervision.
  • Worked Equipment Validation (IQ, OQ & PQ) – In-charge for CRO.
  • Method Development, Validation & Study Sample Analysis.
  • Operation, Calibration and Maintenance of HPLC & LC/MS/MS.
  • Prepare & review documents – General SOPs, Dept.
  • SOPs, Protocols, Schedules (Equipment & Training) & BE Reports.
  • Key person in setting up the Bioanalytical Laboratory and Clinical Unit as well.
  • Established Quality Management System for CRO.
  • Prepare and review documents – General SOPs, Dept.
  • SOPs, Protocol, Schedule (Equipment & Training) and BE Reports.
  • Conducted various experiments e.g.
  • BA/BE, Tissue Distribution, Steady State and Toxicokinetic studies.
  • Introduced the basic concepts of GLP and GCP for regulated research.

Education

MICA - Analytical And Instrumantation

Jiwaji University
Gwalior
07.1998 - 08.2000

Bachelor of Science - Chemistry

MJS Collage, Jiwaji University
Gwalior
08.1994 - 08.1996

Skills

General Software: Phoenix WinNonlin – Pharmacokinetic Analysis Microsoft Excel-Word-Power Point & ChemDrawundefined

Affiliations

  • July2000.
  • Seminar on recent trends in HPLC by Shimadzu Corporation at Hotel Taj Krishna, MUMBAI in February, 2002.
  • Seminar on ‘Latest Regulation, Guidelines, Inspection & Enforcement Trends in pharmaceutical chemistry
  • Attended the training on “Advance HPLC & LC-MS” conducted by Shimadzu (Asia Pacific) PTE Ltd., Singapore) from 04th June 2004 to 06th June 2004.
  • Attended the training course on metabolite identification using met ID software conducted by Lab India on 1Feb- 05Feb 2005.
  • LC-MS/MS user meet attended, MUNNAR, Kerala, and May 2005.
  • Indian pharmaceutical Congress Conferences, Hyderabad, 2006.
  • API 3000 LC-MS/MS Training g course, Onsite –Hands on Training g At Zydus Research center, Ahmedabad by Mr. Tim Liddincot, UK 17-20 July 2000.
  • Seminar on Latest Regulation, Guideline, and Inspection & Enforcement trends in Pharmaceutical Laboratories by Ludwing Huber, Agilent Technologies, Mumbai 2002.
  • LC-MS/MS users meet. Lonavala, 2003
  • Shimadzu Asia pacific workshop for HPLC, Singapore, June 2004
  • IPC conferences, Hyderabad, 2006
  • Attended GLP Workshop on 18 Nov 2008 conducted by Dr. Prakash Diwan of NIPER, Hyderabad at AMA.
  • Attended GLP Workshop on 25th May 2013 conducted by Lambda Therapeutic Research Ltd. Ahmedabad.
  • Attended GCP Workshop on 15th November 2014 conducted by Lambda Therapeutic Research Ltd. Ahmedabad.
  • Attended GLP Workshop on 20th November 2014 conducted by Lambda Therapeutic Research Ltd. Ahmedabad.

Accomplishments

  • Supervised team of 200 staff members.
  • Collaborated with team of in the development of [Project name].
  • Documented and resolved [Issue] which led to [Results].

Software

E-CRF development and implementation and validation

SDMS implemetationa and validation

Biolyte development and implementation and validation

All LC-MS/MS software and its validation

Work Availability

monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
swipe to browse

Timeline

Vice President of Operations

Panexcell clinical Pvt. Ltd
09.2017 - Current

General Manager-Head Bioanalytical

Lambda Therapeutic Research Ltd
03.2013 - 09.2017

Head of Bioanalytical

CRO – Lambda Therapeutic Research Inc
09.2011 - 03.2013

Certified LC-MS/MS Operator and Trainer, certified

AB Sciex
02.2007 - 03.2007

CRO

Lambda Therapeutic Research Ltd
01.2007 - 09.2011

PROJECT MANAGER

08.2002 - 01.2007

Ahmedabad Scientist

07.1999 - 09.2004

MICA - Analytical And Instrumantation

Jiwaji University
07.1998 - 08.2000

Bachelor of Science - Chemistry

MJS Collage, Jiwaji University
08.1994 - 08.1996

Similar Profiles

CREATE PROFILE
Manoj ShuklaBiophrmaceutical Clinical Research