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, USA
Build 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 titrationServe as the primary method troubleshooting resource identify, document, and resolve critical factors affecting method performance across all platformsLead 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 authoringSupport Cleaning Validation sample testing and ensure alignment with FDA Cleaning Validation guidanceInterpret analytical data, compare results against specifications, and prepare trend reports and deviation assessmentsAuthor SOPs, analytical testing procedures, batch release testing forms, and document templatesAssist with laboratory investigations, deviations, and CAPA preparation and executionBecome the resident LIMS expert perform supervisory sign-off for electronic reports and oversee data integrity compliance
U.S. Lab Data Review & Release Support
Review routine and complex laboratory testing data for accuracy, GLP compliance, and specification conformanceReview and approve batch release testing data generated by U.S. lab team membersProvide guidance and mentorship to junior U.S. team members on method execution and complianceServe as point of contact for analytical project updates to U.S. laboratory supervision and clientsSupport 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 laboratoryDefine instrument procurement list HPLC, UPLC, GC, TOC analyzer, FTIR, UV/Vis, and ancillary equipmentDevelop lab-specific SOPs, safety protocols, and quality systems aligned with GMP/GLP standardsOversee instrument qualification (IQ/OQ/PQ) and method transfer from U.S. to India labRecruit, onboard, and train analytical laboratory staff in
MumbaiEstablish 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 platformsHands-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 deviceDemonstrated experience in method development, method transfer, method validation per ICH Q2(R1), and method verification per USPProven expertise in Cleaning Validation - method development, swab/rinse sample testing, MACO limit calculations, TOC and HPLC/UPLC-based verification, and full protocol and report authoringFamiliarity 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 systemsFamiliarity with 21 CFR Part 11 electronic records and data integrity requirementsProficiency 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 preferredFamiliarity 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. teamsSelf-directed, detail-oriented, and capable of managing multiple priorities across time zonesBA/BS required, M.S. or Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or related field preferred
How 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.
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