Job Title

India (Remote + Mumbai Lab Setup) | Full-Time | Supporting U.S. Operations | IST - EST Overlap Required Reporting to: Director of Technical & Analytical Sciences - Hubot CDMO, South Bend, Indiana, USABuild the science. Own the methods. Shape a lab from the ground up.Hubot, Inc. is a U.S.-based CDMO serving Fortune 500 pharmaceutical and personal care brands across North America and globally. Through Hubot India Private Limited, we are building a world-class analytical function that operates in direct partnership with our U.S. Quality and Technical teams. This is a dual-mandate role unlike most analytical positions in the market. You will simultaneously support U.S. lab operations remotely - overseeing method development, transfer, verification, and release data review - while also building and operationalizing Hubot India's analytical and testing laboratory in Mumbai from the ground up.If you are a seasoned analytical chemist who wants to do more than run methods - this is your platform.Why Hubot India ?Lab Builder Opportunity Lead the physical and operational setup of a new analytical lab in Mumbai Global Technical Exposure Direct collaboration with U.S. Analytical, Quality, and Regulatory teams Growth-Stage Platform 25–30% YoY revenue growth forecast through 2030 Method Ownership Full lifecycle responsibility: development, transfer, validation, verification Career Path Clear progression to Principal Scientist or Analytical Sciences Lead (India)Role Overview: This role has two equally important dimensions: 1 U.S. Operations Support (Remote) Serve as the analytical backbone for Hubot's U.S. lab reviewing testing and release data, owning method development and transfer activities, and providing expert troubleshooting support across chromatographic and spectrophotometric platforms.2 Mumbai Lab Establishment Lead the planning, setup, qualification, and operationalization of Hubot India's analytical and testing laboratory including instrument procurement, SOP development, personnel hiring, and regulatory readiness.This role requires 4 - 5 hours of daily overlap with U.S. Eastern Time (~5:00–10:00 PM IST) as and when required.Key Responsibilities Method Development & Analytical Sciences Independently perform method development, method transfer, method verification, and method validation for chromatographic and spectrophotometric techniques HPLC, UPLC, GC, TOC, UV/Vis, FTIR, and titration Serve as the primary method troubleshooting resource identify, document, and resolve critical factors affecting method performance across all platforms Lead Cleaning Validation method development including swab and rinse sample method development and testing, MACO/limit calculations, TOC-based and HPLC/UPLC-based verification, and protocol and report authoring Support Cleaning Validation sample testing and ensure alignment with FDA Cleaning Validation guidance Interpret analytical data, compare results against specifications, and prepare trend reports and deviation assessments Author SOPs, analytical testing procedures, batch release testing forms, and document templates Assist with laboratory investigations, deviations, and CAPA preparation and execution Become the resident LIMS expert perform supervisory sign-off for electronic reports and oversee data integrity complianceU.S. Lab Data Review & Release Support Review routine and complex laboratory testing data for accuracy, GLP compliance, and specification conformance Review and approve batch release testing data generated by U.S. lab team members Provide guidance and mentorship to junior U.S. team members on method execution and compliance Serve as point of contact for analytical project updates to U.S. laboratory supervision and clients Support scheduling and planning of internal and external client project work Mumbai Lab Setup & Operationalization Lead site selection, layout planning, and fit-out coordination for the Mumbai analytical laboratory Define instrument procurement list HPLC, UPLC, GC, TOC analyzer, FTIR, UV/Vis, and ancillary equipment Develop lab-specific SOPs, safety protocols, and quality systems aligned with GMP/GLP standards Oversee instrument qualification (IQ/OQ/PQ) and method transfer from U.S. to India lab Recruit, onboard, and train analytical laboratory staff in Mumbai Establish regulatory readiness for future customer audits and Indian regulatory requirements (CDSCO, BIS as applicable)What You Bring Core Instrumentation Expert Level Required Demonstrated expert-level proficiency in HPLC, UPLC, GC, and TOC - including independent method development, validation, troubleshooting, and data interpretation on all four platforms Hands-on experience with FTIR/ATR-FTIR, UV/Vis spectrophotometry, Karl Fischer titration, and dissolution testing Method & Validation Expertise 8+ years of hands-on analytical chemistry experience in a GMP/GLP-regulated environment - pharmaceutical, OTC, personal care, or medical device Demonstrated experience in method development, method transfer, method validation per ICH Q2(R1), and method verification per USP Proven expertise in Cleaning Validation - method development, swab/rinse sample testing, MACO limit calculations, TOC and HPLC/UPLC-based verification, and full protocol and report authoring Familiarity with USP General Chapters, ICH Q2(R1), FDA 21 CFR 211 laboratory controls, and FDA Cleaning Validation guidance Systems & Compliance Experience with LIMS platforms and electronic data review systems Familiarity with 21 CFR Part 11 electronic records and data integrity requirements Proficiency in chromatography data systems -Agilent, Shimadzu and Thermo preferred Lab Establishment Prior experience in lab setup, instrument qualification (IQ/OQ/PQ), or greenfield laboratory establishment strongly preferred Familiarity with CDSCO or Indian Pharmacopoeia (IP) requirements a plus for Mumbai lab regulatory readiness Communication & Collaboration Strong written English communication skills for cross-functional collaboration with U.S. teams Self-directed, detail-oriented, and capable of managing multiple priorities across time zones BA/BS required, M.S. or Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or related field preferredHow We Measure Success ✅ Method transfer and verification timelines met ≥ 95% on time ✅ U.S. batch release data review turnaround within defined SLA ✅ Cleaning Validation methods developed and approved per project timelines ✅ Mumbai lab operational milestone achieved Month 9–12 ✅ OOS/deviation rate on transferred methods✅ LIMS supervisory sign-off compliance 100%About Hubot India Private Limited Hubot India is a wholly owned subsidiary of Hubot, Inc. (South Bend, Indiana, USA) established to build a world-class technical support function for our U.S. CDMO operations. This is a strategic scientific role with real ownership, real visibility, and a long-term career home. Apply via LinkedIn or message for a confidential conversation#MethodDevelopment #MethodValidation #MethodTransfer #HPLC #UPLC #GC #TOC #CleaningValidation #FTIR #GMP #GLP #LIMS #CDMO #PharmaceuticalSciences #RemoteJobsIndia #LabSetup #OTCDrugs #PersonalCare #HubotIndia #LifeSciences #ICH #USP