Senior Associate Scientist (Chem Analytical)

Role & responsibilities

Accountabilities:

Responsible for Analytical Method development, Method Validation, Method transfer, Investigation, Regulatory support, Routine analytical and stability study support for API, Intermediates, and different DP formulations with minimal or no supervision.

Responsibilities:

• Responsible for method development and validation for Drug substance and Drug product by using HPLC and UPLC.
• Responsible for developing cleaning methods and validation for Tuas site.
• Should be able to perform trouble shooting of analytical challenges which includes method and machine.
• Adhere both quality and safety compliance according to organizational policies/procedures and regulatory guidance.
• Perform assessments of existing data packages, feasibilities and conclude remediation.
• Ensure technical output is compliant with all Global Training Curricula for the instrument operations, material handling and certifications related to, Quality Ops, Manufacturing and EHS.
• Work with the Quality Assurance and other cross functional teams to facilitate the consistent, disciplined execution of the LIR/ER/CAPA quality system ensuring the completeness and comprehensiveness of the assigned task.
• Ensures compliance to local and corporate procedures and ensures all data packages are audit ready and transferable.
• Ensure appropriate GT&E LT review of the formal reports that are considered milestones for decision making.
• Coordinate with cross functional teams to ensure timely execution and resolution of all deliverables versus target milestones.

Preferred Qualifications

M.Sc/M.Pharm

Types of Experience:

• Experience in Analytical Research and Development, possesses knowledge of oral solid dosage forms, liquids, semisolids, and API. Understand regulatory expectations and possess exceptional expertise in data interpretation and scientific outputs.
• Hands on experience in handling HPLC, Dissolution, UV, GC and Wet Chemistry.

Equipment:

HPLC, GC Wet Chemistry, IC and UPLC