Research Associate

• 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.