Research Associate II
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 in-center 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 Description
Job Title –Research Associate II
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 fairly 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.
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, disability/handicap status or any other legally protected characteristic
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. Form Link
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