Research Associate I

Vantive; Hinoba-an; On-site; PHP 793,000 - 1,322,000; Full time

Job summary

Vantive is seeking a Research Associate II (Renal, Solutions) to join our team in Bangalore. The role focuses on product development, design control, and registrations, with cross-functional collaboration across global stakeholders to ensure regulatory compliance and timely delivery.

You will work on complex pharmaceutical projects, lead technical assessments, and help draft reports while mentoring junior staff.

Qualifications

• Clear and effective communication (written, oral) to global stakeholders.
• Excellent stakeholder management (local and global).
• Proven track record of leading small size projects – especially Change Controls in Pharmaceutical industry.
• Experience working in a matrix environment with multiple stakeholders.
• Ability to deliver results by owning budget, timeline, and deliverables.
• Hands-on knowledge of Design Control documentation and process.
• Working knowledge of international/regional/national regulations and standards.

Responsibilities

• As Tech Lead or Change Owner, define, organize, plan and execute activities related to product design change and new product registration in compliance with current international/regional/national regulations with minimal support of senior colleagues or independently.
• Provide technical assessment for product changes related to design, labeling, raw material, manufacturing support, regulatory compliance, quality improvement and new registrations in collaboration with senior scientists.
• Lead, and coordinate - including follow-ups as required with global stakeholders - of technical activities in collaboration with key stakeholders, with respect of project commitment, quality procedures and business needs.
• Provide technical information, &/or prepare reports based on internal or external data available to formulate response to authorities’ questions.
• Propose options, work closely with stakeholders and develop action plan for problem-solving, product and process improvement.
• Establish, maintain and update technical & Design documentation according to Good Documentation Practices.
• Participate in and at times lead multi-functional and international project team for effective collaboration and deliverables.
• Demonstrate excellent internal and cross-functional communication and provide regular status update of activities to senior management & stakeholder with some supervisions from direct manager and senior members of the organization.
• Draft technically accurate reports with in-depth analyses as required using statistics or other relevant tools and mentor/coach help junior members to create information that can go into such reports.
• Lead, and conduct activities related to exploration of innovation concepts and technology platforms, demonstrate critical mindset and “out-of-the-box” thinking.

Skills

Clear communication

Stakeholder management

Project leadership

Matrix environment

English fluency

Problem solving

Education

Master’s in Chemistry or Pharmacy

PhD in Chemistry or Pharmacy

Tools

Statistics

Six Sigma

Job description

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Vantive: A New Company Built on Our Legacy Since last year, we have been on a journey to separate our Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and incenter dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.

Job Summary

Job Title – Research Associate II (Renal, Solutions)

Location – Whitefield, Bangalore

Shift – General

Job Responsibilities

• As Tech Lead or Change Owner, define, organize, plan and execute activities related to product design change and new product registration in compliance with current international/regional/national regulations with minimal support of senior colleagues or independently.
• Provide technical assessment for product changes related to design, labeling, raw material, manufacturing support, regulatory compliance, quality improvement and new registrations in collaboration with senior scientists.
• Lead, and coordinate - including follow-ups as required with global stakeholders - of technical activities in collaboration with key stakeholders, with respect of project commitment, quality procedures and business needs.
• Provide technical information, &/or prepare reports based on internal or external data available to formulate response to authorities’ questions.
• Propose options, work closely with stakeholders and develop action plan for problem-solving, product and process improvement.
• Establish, maintain and update technical & Design documentation according to Good Documentation Practices.
• Participate in and at times lead multi-functional and international project team for effective collaboration and deliverables.
• Demonstrate excellent internal and cross-functional communication and provide regular status update of activities to senior management & stakeholder with some supervisions from direct manager and senior members of the organization.
• Draft technically accurate reports with in-depth analyses as required using statistics or other relevant tools and mentor/coach help junior members to create information that can go into such reports.
• Lead, and conduct activities related to exploration of innovation concepts and technology platforms, demonstrate critical mindset and “out-of-the-box” thinking.

Qualifications

• Master’s in Chemistry or Pharmacy (or related disciplines) with minimum 4 years of relevant experience, or PhD in chemistry or Pharmacy (or related disciplines) with experience in Pharmaceutical product development and life cycle management, preferably sterile injectable/parenteral formulations.
• Demonstrated ability in clear and effective communication (written, oral) and presentation skills to global stakeholders.
• Excellent stakeholder management (local and global).
• A proven track record of leading small size projects – especially Change Controls in Pharmaceutical industry.
• Demonstrated ability to work in a matrix environment with multiple stakeholders.
• A proven track record of effectiveness in a fast-paced environment working in global teams.
• Proven ability to deliver results by owning & being accountable for budget, timeline, and product/project deliverables.
• Skills.
• Adequate orientation towards Renal PD therapies and products with time.
• Hand-on knowledge of product development stages and life cycle management: development, stability, clinical, registration, process/technology transfer, production, suppliers, customer service.
• Hands-on knowledge of Design Control documentation and process.
• Working knowledge / familiarity of international/regional/national regulations and standards.
• Demonstrated project management experience where business acumen, prioritization and portfolio management skills were required.
• Experience with Statistics and Six Sigma tools.
• Ability to work independently.
• Can effectively communicate with internal and external customers.
• Demonstrates flexibility and the ability to shift gears between projects comfortably.
• Fluency in English.
• Solid computer skills: email, documentation, and collaboration tools: e.g., WebEx, Teams, Microsoft Office products, etc.

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.