Research Associate Ii

2 months ago

Bengaluru, India BAXTER Full time

**This is where you save and sustain lives**

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

**About Baxter**:
Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.

**Job Summary**
- **Job Title - Research Associate II (Renal, Solutions)**:

- **Location - Whitefield, Bangalore**:

- **Shift - General**

**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 mínimal 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 wi

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