Research Associate II at Baxter

Job Description

• Job Summary
• Job Title –Research Associate II
• Location – Whitefield, Bangalore
• Shift – General

Job Responsibilities:

• Provide technical support and leadership for life cycle management activities for the products of interest 
• As 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 and strategy 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.
• Independently create 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.

Qualifications

• Master’s in chemistry or Pharmacy (or related disciplines) with minimum 6 years of relevant experience.
• Demonstrated ability in clear and effective communication (written, oral) and presentation skills to broad set of global stakeholders.
• Excellent stakeholder management (local and global).
• A proven track record of leading small to moderate 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 Kidney care therapies and products with time.
• Hand-on knowledge of product development stages and life cycle management: development, stability, clinical, registration, process 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 are 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.