Project Manager Team Member
Resume:
NILESHKUMAR MENGER
*************@*****.***
CARRIER OBJECTIVE:
I seek to enhance my theoretical skills through practical exposure by working with a professional organization that inspires people to strive for their best performance. SUMMARY:
More than 10 years of Leadership and Operation experience in Pharmaceutical R&D / CRO / Biopharmaceutical / Biotechnology industries.
More than 8 years worked as a Scientist in drug development area (Pre-clinical, Clinical and NCE molecules).
More than 6 years of experience in Quality Assurance Department in CRO (Pre-Clinical, Clinical and Phase Trials) Industries.
More than 2 years of Project Management experience in Biopharmaceutical / CRO (Pre-Clinical, Clinical and Phase Trials) Industries.
o Oversees all aspects of projects, sets deadlines, assigns responsibilities. o Works with management /departments to resolve project issues and resource constraints within the team.
o Provides project management leadership to cross-functional team. o Maintains positive team member interactions and conflict management. o Monitor overall project activities and ensures completion of all activities outlined in the client quote for each project.
o Creates and maintains client timelines, deliverables, and amendments for changes of scope in a timely manner.
o Manages client and other project stakeholder relationships, communications, requirements and expectations, and interfaces directly with the client. o Assistance with identification of project risks and the development and implementation of risk mitigation strategies/solutions as appropriate.
o Supports clinical and commercial development initiatives. o Supports resolution of project issues by assisting in follow-up actions and communication internally and externally.
Knowledge of GxP (GMP / GCP / GLP), EMEA, Health Canada and FDA requirements.
Knowledge of ISO 9001, ISO 13485 standards and Medical Devices.
Review and approve laboratory equipment operation, calibration, and maintenance records.
Review and approve SOPs, audit reports and audit responses to ensure that all non-conformance issues have been addressed satisfactorily.
Responsible for planning and execution of regulatory and sponsor specific inspections.
Play a vital role in the training/mentoring of staff with regards to company standards (e.g., SOPs/Policies) and regulatory requirements.
High level of accuracy and strong attention to detail.
Solid analytical and strategic capabilities.
Ability to work independently and in a team.
Certification:
Certified Project Management Professional - 3436834 (PMP® - From PMI)
cGMP: Introduction to Good Manufacturing Practice - An Abridged Course
Good Manufacturing Practice from Canadian College of Food and Health
Master’s Diploma in Pharmaceutical Management (Gold Medalist) Software knowledge:
EDC data acquisition software knowledge: Nugenesis, LIMS, BioLyte, BizNet, eQMS Software: MasterControl, Trakstar (Mind Flash), Smartsheet Instrument Software Knowledge:
LC-MS/MS Software knowledge: Analyst (AB Sciex), LC Quan (Thermo), Mass Lynx (Water’s) HPLC Software knowledge: Shimadzu (Class VP), Agilent (1100 and 1200 Series) PROFESSIONAL EXPERIENCE:
Microbix Biosystems Inc. Dec 2020 – Till date
(Quality Assurance Manager)
Microbix is a leading manufacturer of viral and bacterial products used in the manufacture and quality assessment of diagnostic tests. Develops and commercializes proprietary biological and technological solutions for human health and wellbeing.
Develop, implement, and maintain a quality management system(s) (QMS) appropriate for the Company's size and stage of development by creating applicable policies, SOPs, and records.
Establish, manage, and maintain the GXP Document Control and Training System.
Acts as subject matter expert and provides training on Quality Management System processes
(Document Management, Quality Events, Corrective and Preventive Actions (CAPA), Change Controls, Complaints), corresponding regulatory requirements and best industry practices.
Manage inquiries or potential product complaints from the market, regulatory agencies, or clients.
Investigate and or resolve internal quality events in collaboration with technical leads and vendors.
Prepare and host periodic Quality Management Reviews to assess the health and effectiveness of the QMS.
Develop, analyze, trend and report quality metrics.
Implement and oversee the Internal Audit Program. Conduct Audits as needed.
Support and administer the Supplier Management Program for GXP programs.
Develop the GXP audit schedule in close collaboration with the QA and functional leads. Report audit schedule compliance.
As needed, lead, plan, and conduct GXP audits, including vendor qualification audits.
Follow up on audit commitments with suppliers.
Provide support in the preparation, conduct, and follow-up activities associated with regulatory inspections.
Provide GXP compliance guidance to cross-functional teams within the organization.
Foster a quality culture that values innovation, continuous improvement, and personal accountability. Support GXP systems and process improvement initiatives; lead continuous process improvements.
Other duties and responsibilities as assigned and needed. Novum Pharmaceutical Research Services Inc. April 2014 – Dec 2020
(Senior QA Auditor)
Novum Pharmaceutical Research services Inc. is a leading global CRO providing full drug development services. With operations in India, Canada, Poland, UK, & USA applies innovative technologies, therapeutic expertise, and a commitment to quality to help clients develop products, safely, effectively, and quickly. Position Held: Quality Assurance Auditor (April 2014- May 2017) Duties:
Leading a Quality Assurance department with the help of three QA Associates.
Conducts study base audit for compliance to protocol, SOPs, Policies, GCP, OECDGLP and Health Canada, USFDA, EMEA regulatory requirements.
Responsible for planning of standard project timeline in co-ordination with department and project manager.
Attends project team meetings, client conferences and on-site visits.
Assists Site Project Manager in planning, coordinating, and tracking functional team activities, timelines and deliverables for each project.
Write, revise and review SOPs and related Change Control procedures in compliance with organization standards/policies and participates in the review cycle of SOPs.
Review of electronic Case Report Form (eCRF) of clinical and Phase studies.
Managed quality programs implemented quality actions: clinical trial monitoring, documentation audit, process audit, CAPA, investigation and SOPs.
Hosted FDA, EMA inspection and sponsor audits.
Hosted SCC GLP certification inspection.
Various stage of the clinical trials auditing/monitoring experience: from protocol IRB submission, ICF, dosing monitoring, bioanalytical analysis till final report release.
Bioanalytical method validation, PK sample bioanalysis experience.
Computer software validation, LIMS, LC-MS instrumentation, HPLC, CDMS system, SAS, Nugenesis and other analytical instrumentation.
Responsible for the GLP inspection from Standard Council of Canada (SCC).
Planning and execution of regulatory and client/sponsor-based audits.
Planning and execution of internal facility audits as per internal procedures and identifies the areas of improvements.
Preparing the yearly executive summary report and presenting to senior management through Quality Review Meeting (QRM).
Responsible for preparation, coordination and action plan resulting from regulatory inspections or client site audits.
Identifies the area for continuous improvements within the organization.
Training/mentoring of staff with regards to organization standards and regulatory requirements. Nektar Therapeutics Research Sep 2006 – Jan 2014
Senior Scientist (R & D Laboratory Manager – BA/BE/Pre-clinical) Nektar Therapeutics is an American biopharmaceutical company based in San Francisco, California. Nektar Therapeutics is a research-based development stage biopharmaceutical company that discovers and develops innovative medicines in areas of high unmet medical need. We have other facilities located in Huntsville, Alabama and Hyderabad, India. Positions Held: Scientist- I (Sep 2006 – Jan 2009), Scientist – II (Feb 2009 – Jan 2011) Duties:
Leading Bioanalytical laboratory operations.
Leading team of 12 people (research scientist) and managing planning and execution of method development, validation and sample analysis of research, clinical and pre-clinical studies in different matrices under GCP/GLP norms using LC-MS/MS.
Individual project handling as “Principal Investigator” for clinical programme and “Project Lead” for research and preclinical studies based on R & D pipeline.
Evaluation and approval of CRO/CMOs for pre-clinical studies and manufacturing activities.
Sound technical knowledge of analytical instruments.
Review and approve method development, qualification, and sample analysis reports.
Review and approve master documentation, laboratory testing/protocols/reports and associated change controls.
Worked as “Global Project Manager” to co-ordinate and streamline all analytical, manufacturing, research, clinical and pre-clinical projects related activities across the three sites (one site India and two sites in USA).
o Oversees all aspects of projects, sets deadlines, assigns responsibilities. o Works with management /departments to resolve project issues and resource constraints within the team.
o Provides project management leadership to cross-functional team. o Maintains positive team member interactions and conflict management. o Monitor overall project activities and ensures completion of all activities outlined in the client quote for each project.
o Creates and maintains client timelines, deliverables, and amendments for changes of scope in a timely manner.
o Manages client and other project stakeholder relationships, communications, requirements and expectations, and interfaces directly with the client. o Assistance with identification of project risks and the development and implementation of risk mitigation strategies/solutions as appropriate.
o Supports clinical and commercial development initiatives. o Supports resolution of project issues by assisting in follow-up actions and communication internally and externally.
o Preparing the project timelines in co-ordination with different departments. o Monitor overall project activities and ensures completion of all activities outlined in the client quote for each project.
o Creates and maintains client timelines, deliverables, and amendments for changes of scope in a timely manner in Gantt chart.
o Supports resolution of project issues by assisting in follow-up actions and communication internally and externally.
o Leading key project team meetings, client conferences and on-site visits. GVK Bioscience Pvt. Ltd. Jan 2006 – Aug 2006
(Laboratory Manager – BA/BE/Clinical)
GVK Biosciences (GVK BIO) is Asia’s leading Discovery, Research and Development organization. GVK BIO provides a broad spectrum of services, stand-alone and integrated, across the R&D value chain. Duties:
Responsible for Laboratory operations (Analytical, Bioanalytical and Clinical).
Leading team of 20 people and managing method development, validation, and sample analysis of analytical and Bioavailability/Bioequivalence (BA/BE) studies under GCP/GLP/ICH norms using LC- MS/MS and HPLC as per USFDA, EMA and ANVISA regulatory guideline.
Review and approve method development, validation, and sample analysis reports.
Review and approve laboratory testing, protocols, report, and associated change controls.
Ensured all results and documentation were of high quality, generated in a timely fashion and regulatory-compliant (USFDA, EMA and ANVISA).
Handled regulatory inspections from different regulatory like USFDA, EMA and ANVISA.
Single Point of Contact (SPOC) for client audits. Sun Pharmaceutical Industries Ltd. Feb 2001 - Dec 2006
(Executive R&D)
Positions Held: Research Associate (Feb 2001 – May 2002), Research Officer (Jun 2002 – May 2005) Duties:
Sun Pharmaceutical Industries Limited is an Indian multinational pharmaceutical company headquartered in Mumbai, Maharashtra that manufactures and sells pharmaceutical formulations and active pharmaceutical ingredients (APIs) primarily in India and the United States.
Duties:
Leading team of 8 scientist.
Performed Method development, validation, and analysis of pharmaceutical raw materials (API) and finished products as per pharmacopoeia requirements (IP, BP, USP), SOPs and ICH guideline.
Performed method development, validation, and sample analysis of Bioavailability/Bioequivalence
(BA/BE) studies under GLP/GCP requirements.
Involved in the analytical method transfer to different lab and pharmaceutical manufacturing locations asper GMP requirements.
Performed stability studies on various forms of pharmaceutical finished products under normal and accelerated degradation conditions as per ICH guideline using LC-MS/MS, HPLC/UPLC, IR and UV- spectrometer.
Performed different tests like disintegration, dissolution, content uniformity and moisture of pharmaceutical products (API and finished products) according to USP and BP pharmacopeia methods and in-house SOPs.
Built technical writing skills, SOP preparation, compiled test results and reports. Choksi Analytical Pvt. Service Jul 1998 - Jan 2001
(Analytical Chemist)
Choksi Laboratories Limited, as it is more widely known, is a leading analysis and research group, providing complete solutions for improving quality in pharmaceutical raw materials and formulations, agro products and their derivatives, fertilizers, pesticides, edible and industrial oils, chemicals, paints, and dyes. Duties:
Performed wet tests of pharmaceutical raw materials (APIs).
Performed different test like disintegration, dissolution, content uniformity and moisture of pharmaceutical products (API and finished products) according to USP and BP pharmacopeia methods and in-house SOPs.
Performed stability studies on various forms of pharmaceutical finished products as per ICH guideline using HPLC, IR and UV-spectrometer.
Gained solid working knowledge of automated instruments like HPLC and GC.
Performed instrument’s calibration, maintenance and trouble shooting.
Summarized data and record of all experiments and generated reports. EDUCATIONAL QUALIFICATION:
Master of Chemistry (M.Sc.)
Maharaja Sayajirao University (MSU) India 1998
Bachelor of Science (B.Sc.)
Maharaja Sayajirao University (MSU) India 1996
Professional Qualification:
1. Pharmaceutical Quality Control and Quality Assurance Management – 2001 2. Pharmaceutical Production Management – 2002
3. Project Management of Pharmaceutical – 2004 (Gold Medalist) Project Management Certification (From PMI):
Project Management Professional (PMP®)
Reference: Available upon request.
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