Research Associate II – Life Cycle Management (LCM) Scientist
Req #: JR-166862
Location: Whitefield, Bangalore, India
Job Category: General R&D
Employment Type: Full-Time
Company Overview:
Vantive is a leading organ therapy company focused on extending lives and improving patient care globally. Building on nearly 70 years of expertise in kidney care, Vantive delivers innovative solutions in acute therapies, home and in-center dialysis, and is expanding into vital organ therapies. Our mission is to enhance therapy efficiency, elevate patient outcomes, and foster a collaborative, innovative work environment.
Role Summary:
We are seeking a Research Associate II – Life Cycle Management Scientist to lead and support analytical method development, validation, and transfer activities. This role involves working with global cross-functional teams, supporting new product development (NPD) and sustaining product operations (SPO), and ensuring compliance with international and regional regulations.
Key Responsibilities:
Represent Global R&D – Analytical on project teams, contributing to project success and goal achievement.
Develop, execute, and manage analytical plans for NPD and sustaining product projects.
Execute laboratory activities for analytical method development, validation, and transfer across R&D and manufacturing sites.
Perform analytical gap assessments and provide strategic remediation plans.
Prepare and review analytical documentation, including validation, transfer, and development protocols/reports.
Support regulatory submissions and responses to authorities, contributing to global compliance.
Act as study director for method validation and transfer studies.
Collaborate with global functions including project management, regulatory, formulation, manufacturing, suppliers, and quality control.
Mentor and coach junior team members in analytical activities, including method development, validation, transfer, and gap assessments.
Apply analytical expertise to solve complex technical problems, identify risks, and ensure project milestones are met.
Maintain compliance with cGxP, ICH, Ph. Eur, USP guidelines, and other relevant regulatory requirements.
Manage ownership of analytical methods, SOPs, and laboratory instruments; assist in budget and activity scheduling for analytical projects.
Experience & Requirements:
Master’s degree in Chemistry, Pharmaceuticals, or related field with 7–10 years of relevant experience.
Proven experience in analytical method development, validation, and transfer.
Hands-on experience with analytical instruments such as HPLC, GC, Potentiometer, UV, AAS, FES, and software like Empower.
Strong knowledge of cGxP practices, ICH, Ph. Eur, USP guidelines, and laboratory compliance.
Demonstrated ability to work in global cross-functional teams across multiple time zones.
Excellent verbal and written communication skills; ability to organize, assess, and communicate complex scientific information.
Strong analytical and critical thinking skills; ability to design experiments, solve technical problems, and make informed decisions independently.
Ability to manage multiple priorities, deadlines, and conflicts efficiently.
Why Join Vantive:
Vantive provides an opportunity to work on transformative therapies in a mission-driven, innovative environment. You will contribute to global patient care initiatives, collaborate with world-class experts, and develop your professional expertise while making a meaningful impact in organ therapy solutions.
Equal Employment Opportunity & Accessibility:
Vantive is committed to providing reasonable accommodations for individuals with disabilities globally and fostering an inclusive workplace.
Learn More: Vantive Careers
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