Research Associate III (Testing Coordinator)

Job Summary

The Research Associate III (Testing Coordinator) is responsible for driving operational excellence in analytical and stability-related laboratory projects at the Whitefield, Bangalore facility. This role involves streamlining processes, coordinating with subject matter experts (SMEs) across business, management, and technical domains, and identifying and mitigating risks. The Testing Coordinator ensures the timely and compliant execution of all laboratory testing activities, supporting the establishment and maintenance of operational excellence within the organization.

Responsibilities

• Provide business and execution leadership for multiple analytical and stability-related projects, maintaining accountability for testing schedules and risk management.
• Lead and implement internal initiatives aimed at enhancing operational excellence.
• Interact with platform core team leaders and key business stakeholders to proactively anticipate and address business needs.
• Collect and process inputs from Global Analytical, Stability Functional Leaders, Analytical Leads, and Stability SMEs to schedule and forecast resource allocations.
• Ensure the availability of all prerequisites for scheduled laboratory analytical and stability testing.
• Master planning for testing activities, guaranteeing on-time completion of all testing.
• Effectively coordinate testing with global teams and Contract Research Organizations (CROs) to meet Key Performance Indicators (KPIs) on schedule.
• Liaise with other testing groups (e.g., Particle, Sterility/BET) to align schedules with business commitments.
• Maintain laboratory compliance in accordance with regulatory requirements.
• Ensure import licenses are secured and manage laboratory sample inventory.
• Coordinate with procurement and technical teams for timely procurement of chemicals and resolution of analytical instrument issues.
• Coordinate with internal and external sample shipment personnel to receive testing samples promptly.
• Participate in laboratory investigations concerning atypical or out-of-specification/out-of-trend test results and other nonconformance records, using critical thinking to propose and document corrective and preventive actions.
• Author and adhere to Standard Operating Procedures (SOPs) for laboratory operations.

Qualifications

• Master’s degree in Chemistry or Pharmaceuticals (preferred) with 5 to 10 years of relevant experience; or Bachelor’s degree with 8-14 years of experience in a related scientific discipline (Analytical Chemistry/Pharmaceutical Chemistry).
• Proven experience in stability testing, analytical method validation and transfer, and laboratory management.
• Strong leadership and project management capabilities.
• Excellent communication and interpersonal skills.
• In-depth understanding of Quality System Regulations (QSRs), Good Practice (GxP) guidelines, and other applicable regulatory requirements.
• Proficiency in laboratory management software, such as Trackwise.
• Strong resource planning and inventory management skills.
• Advanced problem-solving and critical thinking abilities.
• Ability to work effectively with cross-functional and global teams.
• Proactive mindset with the capacity to anticipate business needs and challenges.
• Basic computer proficiency (MS Office: Word, Excel, PowerPoint, etc.).

Preferred Skills

• Experience coordinating with international and remote teams.
• Previous exposure to contract research organization (CRO) collaborations.
• Experience authoring SOPs and ensuring laboratory compliance.
• Familiarity with laboratory investigation and root cause analysis methodologies.
• Knowledge of import/export compliance for laboratory materials.

Experience

• Minimum 5 years of relevant experience with a Master’s degree, or 8-14 years with a Bachelor’s degree in Analytical Chemistry, Pharmaceutical Chemistry, or a related scientific discipline.
• Demonstrated experience in stability testing, analytical method validation, laboratory management, and regulatory compliance.

Environment

• Location: Whitefield, Bangalore.
• Work Setting: On-site, general shift.
• Laboratory environment with routine interactions with global teams, internal departments, and external partners (including CROs).
• Physical demands may include handling laboratory samples and materials, and use of standard laboratory equipment.

Salary

• Estimated salary range: ₹15 - ₹30 lakhs per annum.

GrowthOpportunities

• Potential for advancement into senior operational, project management, or scientific leadership roles within the organization.
• Opportunities to lead high-impact initiatives and cross-functional teams.
• Exposure to global project coordination and high-visibility assignments.

Benefits

• Not specified.