James D. Terish Bin has over 14 years of experience in the pharmaceutical industry, holding roles in analytical development, bioequivalence studies, quality management, and business development. He has a Doctorate in Pharmacy and has led teams of over 100 people, developing new services, growing businesses, and ensuring regulatory compliance. Currently he is the AGM of Operations at Sequent Research Limited, leading their bioanalytical and analytical services across multiple locations.

1. JAMES D. TERISH BINO
Doctorate in Pharmacy with 14 years’ operational experience having in-depth
understanding in pharmaceutical life cycle like Pre Clinical research, bulk drug and
Product development, Bioequivalence and bioavailability, Manufacturing support,
regulatory submission and aftermarket handling.
Developed and expanded business and services - Built Analytical, bio-analytical and
clinical research organization as per regulatory requirements.
Customized diagnostic tools for IEM in new born screening and TDM.
Familiarity with DMPK and clinical trials, Exposure in Pharmacovigilance and clinical
data management.
Handled regulatory audits – TGA, USFDA, WHO (two times each) and ISO 17025
accreditation.
Conducted 50 BA/BE studies including 4 FDCs and ADME Studies, Developed and
validated 35 bio-analytical methods.
Handled analytical method development, validation, transfer, optimization, improvement,
fixed specifications and implemented for routine analysis.
Commercialized niche techniques like Liposomes Leak test, studies for drug binding, and
stability in biological matrix using RED devices.
Created Organizational business plan and Yearly budgeting, carried out due diligence and
evaluation audits for inorganic growth, handled asset acquisition, developed new services
based on market requirement and promotion of services, handled Capex investment for
new business and services, Opex handling, vendor management, Recruitment and
training, MOM reporting to management about deliveries, quality and P&L.
Quality Management system
Designed and harmonized QMS, SOP updating based on latest regulatory requirement,
monograph revision and good industry practices, built effective training system,
implemented proven OOS, OOT, Incident, Deviation and CAPA systems as per
regulatory and industry norms, conducted internal audits.
Implemented lab systems like LIMS, Chromeleon, and ERP in multilocation
Driven for certifications like ISO 9001, 14001, 18001.
Regulatory support for Dossier submission like ANDA, DMF, eCTD for BA/BE studies
and CTs, technical query handling.
Information technology – Implemented 21 CFR part 11 compliance including CSV,
Network and server qualification, Software qualification, Excel qualification, Data
control and integrity, Back up, Restoration, Software control and Privilege creation, Desk
top control and Integrating instrumentation to LIMS, reconciliation using LIMS, creation
and deactivation of Ids.

2. Business Development – Conducted market research and analysis, Customer relationship
and conflict resolution, responding to RFIs, RFQs or RFPs, creating and reviewing MSA,
Confidentiality agreements, task orders or rate contract for customers, technical and cost
discussions / negotiations with customers, coordinating feasibility reports, Represented
Company in trade shows and conferences.
Project Management - Define the project’s objectives and oversee quality control
throughout life cycle, Cost/benefit and Project feasibility analysis, Project risk
assessment/Critical path identification and management, milestone fixing, Resource
Management, Project budgeting, monitoring and control, Creating, updating and
maintenance of Project Master Schedule.
God fearing, Enthusiastic, Sincere, Hardworking, Target oriented, committed, interested
in Pharmaceutical Operations, Business development, RnD, quality and regulatory.
Experience
Sequent Research Limited, AGM Operations - Present
Analytical and Bio-analytical Research Organization catering services for drug
discovery/development, Pharmaceuticals, FMCG, Veterinary drugs, API. 100% own
Subsidiary of Sequent scientific limited. www.sequent.in
Key Responsibilities - Leading Bioanalytical and Analytical services in multi locations
with team strength of 130+. Business expansion based on growth plan, developing new
capabilities/ services based on market/ business requirements, resources management and
operational improvement.
Working with GLC and Management in Yearly budgeting, Capex procurement, revenue
generation and mapping, review of MIS, and attending MRM/ORM, cost and
productivity per capita analysis/ROI, Monthly and yearly sales, and expenses
management.
Timely Deliveries, Lab compliance and continuous improvement, upholdment of
approval/ certification/ accreditation status, handling audit/ visits, conducting BE/BA,
Stability, DMPK studies, Responding to regulatory queries.
Developed new services and expanded to new location. Turned around the organization
with 30% YOY growth.
Semler Research Center, Associate Manager and Head Bio-analytical Services – Jan
08 to Jul 09
A 30 million privately owned pharmaceutical services company with its business offices
in Los Angeles, CA and Bangalore, India providing a wide range of services, primarily in
the areas of pharmaceutical development, bioavailability & bioequivalence studies, early
& late phase clinical development, regulatory services and medical & scientific writing.

3. Key responsibilities: Managed 20+ Bio-analytical scientists/ analyst
Conducted more than 20 BA/BE studies, Developed and validated bio-analytical method
as per regulatory requirements for 40 molecules including FDCs using HPLC, LCMSMS
in various matrices.
Handled 3 preclinical studies for Oncology drug for parameters like binding, stability,
permeability etc
Improved bioanalytical efficiency by increasing the output, updated the system as per the
regulatory requirements and maintained the GLP compliance and which was audited by
WHO, USFDA, ANVISA and Turkey MOH
Azidus, Manager – Bio-analytical department – Oct 05 to Jan 08
A clinical research organization catering to the technical needs of pharmaceutical and
biotechnology industries for the conduct of BA/BE studies, Clinical trials, Clinical Data
Management, Pharmacovigilance and Regulatory submission to the Global drug
regulatory agencies.
Key responsibilities: Designed, Developed and established the Clinical, Bioanalytical,
Volunteer recruitment services.
Implemented system as per regulatory requirements, Negotiated and procured the
required instruments.
Facilitated and handled statutory requirements and customer audits.
Developed 25 methods and supported the clinical Phase.
Made the services available in stipulated timelines.
SGS Life sciences, Executive – Bio-analysis – Dec 04 to Jun 05
SGS is the world’s leading inspection, verification, testing and certification company. It
is recognized as the global benchmark for quality and integrity. With more than 80,000
employees, they operate a network of more than 1,650 offices and laboratories around the
world.
Key responsibilities: Core member in developing the bio-analytical services including
infrastructure and system. Supported statutory, regulatory and customer audits.
Involved in procurement and maintaining inventory.
Method development, validation, sample analysis, documentation and reporting.
Instrument installation, qualification, handling and management.
GVK Biosciences, Junior Research Associate – Mar 04 to Oct 04
One of Asia’s leading Discovery Research and Development organization providing
broad spectrum of services, across the R&D and manufacturing value chain with a focus

4. on speed and quality. Its capabilities include Integrated Progr ams, Discovery Services,
Clinical Development, Contract Manufacturing, Formulations and Informatics.
Key responsibilities: Worked in developing system like writing SOPs, Bio-analytical
method development, validation, method protocol, validation report, method SOP,
analysis and study report.
Developed bio-analytical methods in various matrices for small molecules in oral dosage
forms like tablets, FDCs and analysis, Clinical sample collection, separation and
management. Carried out analysis within timelines, handled instruments for analysis,
maintenance and periodic calibration.
Shasun Chemicals and Drugs Ltd, Management Trainee QA - May 03 to Feb 04
A leading supplier of development and manufacturing services for intermediaries, API,
and formulations to the pharma industry.
Key responsibilities: Daily plant audit, COA review and release, dispatch inspection,
audit support, and archival and retrieval of documents.
Instrumentation Training – SPIC Science Foundation - Oct 02 to Mar 03
Scholastics
Examination Name of the Institution University/Board
Month and Year
of Passing
% of
Mark
Ph.D
(Pharmacy)
Annamalai University
Annamalai
University
Provisional
Certificate to be
received
-
M.Pharmacy
Vel’s College of
Pharmacy, Chennai
Dr. MGR Medical
University
September 2002 69.7
B.Pharmacy
S. A. Raja’s Pharmacy
College, Vadakkangulam
Dr. MGR Medical
University
December 1999 59.32
HSC
Scott Christian HSS,
Nagercoil
Board of Higher
Secondary
Examination
March 1994 76.33
SSLC
LMS HSS for Boys,
Marthandam
Board of Secondary
Education, TN
April 1992 88

5. Personal Information
Birth Date : 07 August 1976
Gender : Male
Current Residence : Bangalore, India
Mobile Phone : +91 9880540355, +91-9902479793
Language : English, Tamil, Malayalam (to speak)
Email : jdterish@outlook.com
Linkedin : http://in.linkedin.com/pub/james-terish/14/763/102
Skype : jdterish (available after 7 p.m)
Passport : Z2558740
References : On request