Oversee and lead a group of 12-14 scientists in the Analytical Development laboratory
Plans and directs all activities in analytical development laboratory and execute those activities smoothly.
Assists the director to track and monitor the department budget (operational expenses, capital expenses and head counts) according to the agreed budget.
Ensures Analytical Development department is in compliance with cGLP and cGMP.
Leads analytical discussions with clients for all clients' analytical projects.
Provides internal and external technical support for methods development, transfer and validation, etc activities.
Responsible for scientific proposals, procedures, specifications and reports.
Works closely with other functional areas such as Formulation, Project Management, Quality Control, Quality Assurance and Commercial Manufacturing as well as with clients to meet the timelines and requirements.
Participates in research and development activities and is accountable for preparation of all technical documents to support our clients' submissions for INDs, NDAs, and ANDAs, etc.
Provide technical support for regulatory agencies and clients’ inspections/audits.
Analytical Skills and knowledge of scientific protocols and complex scientific principles necessary to provide inputs on complex experiments and research on chemicals and medicines.
Author, Review and/ or Approve the technical documents such as protocols, reports, change controls, calibration records, CAPAs, Manufacturing protocols/ reports etc.
Problem Solving - Ability to find a solution for or to deal proactively with work-related problems; ability to look beyond the standard solutions.
Ability to design/ conduct and write a systematic, objective, and critical investigation.
Advanced computer skills and be able to develop conclusions based on information from multiple sources.
Any assigned task by laboratory managements
Must have experience with FDA, EMA and other regulatory inspections etc.
A Bachelors of Science in analytical or pharmaceutical related field.
7+ years of experience in the area of analytical development, pharmaceutical and contract services laboratory with 3+ years of supervisory role/analytical project management role