Job Overview
This role is responsible for leading and coordinating activities within the Analytical R&D function, ensuring that analytical strategies, laboratory operations, and cross-functional collaboration are aligned with overall business objectives. The position also oversees laboratory infrastructure, analytical systems, and compliance-related matters to support efficient and high-quality R&D execution.
Responsibilities
- Provide analytical expertise to support API process development, pharmaceutical development, and regulatory submissions, including method validation, analytical testing, stability programs, data interpretation, and preparation of scientific documentation.
- Review, assess, and endorse analytical and technical documents to ensure scientific rigor, regulatory compliance, and clarity, such as analytical methods, study protocols, validation reports, SOPs, technical reports, and method transfer packages.
- Evaluate and verify analytical documents prepared for submission to regulatory authorities, ensuring alignment with applicable guidelines and expectations.
- Act as a technical advisor to internal stakeholders, offering analytical insights and problem-solving support across departments when required.
- Collaborate with cross-functional leaders to facilitate communication and address interdepartmental issues that may impact project execution.
- Partner with management to define study timelines, resource plans, and analytical strategies that support company R&D priorities and project milestones.
- Contribute to the development, refinement, and implementation of internal procedures, workflows, and policies related to Analytical R&D operations and resource utilization.
- Lead and support the resolution of technical challenges within the Analytical R&D team by providing expert guidance or identifying appropriate internal or external resources.
- Oversee departmental resource planning, including budgeting, manpower allocation, laboratory facilities, and equipment utilization.
- Work closely with Quality Assurance to ensure Analytical R&D activities comply with GMP requirements and internal quality standards.
- Ensure laboratory operations adhere to environmental, health, and safety (EHS) regulations and internal compliance requirements.
- Manage the full lifecycle of laboratory instruments, including procurement, qualification, routine maintenance, calibration, repair, and decommissioning, to ensure continuous compliance and operational readiness.
- Supervise the management and compliance of electronic and computerized systems used within the Analytical R&D department.
- Perform additional tasks or projects as assigned by management to support organizational needs
Requirements
- Ph.D. degree in Chemistry, Pharmaceutical Sciences, Analytical Science, or other relevant scientific disciplines.
- Hands-on industry experience in API, formulation, or CDMO environments, with a strong understanding of analytical development and GMP-regulated operations.
- Solid background in analytical method development, validation, and regulatory-driven documentation.
- Proven ability to work cross-functionally and provide technical leadership in a matrix organization.
- Familiarity with regulatory expectations for analytical data supporting development and registration is preferred.
