Job Outline:
- To supervise and lead method development, validation and analytical testing activities in the I&D Analytical Team.
- To improve analytical methods, maintain and troubleshoot instrumentation and integrate any new analytical requirements into the facility.
- To maintain a safe, clean and efficient laboratory.
- To plan the resources required for method development and validation to meet the timeline of New Product Development (NPD) and reformulation projects. This includes preparing the Method Development and Validation work plan, define and follow-up on yearly targets and objectives in supporting the needs for business development projects.
- To liaise with internal clients including Innovation & Development, Product Pipeline, Technical Services, Regulatory Affairs, QC Laboratory for activities relevant to analytical method development and validation, stability study and other analytical testing required.
- To ensure the continuous improvement of I&D Analytical Team and alignment of the Analytical Team with the Company’s strategies.
Duties and Responsibilities:
- To work in a highly-structured work environment with regard to safety and consistent conformance to operating procedures and work practices.
- To ensure timely throughput of product through work queues through a trained and flexible team. This includes updating the work schedule of the Analytical Team weekly, as well as altering the schedule as necessary.
- To reinforce safety standard and good housekeeping in the I&D Laboratory. Alert any hazards or unsafe behaviors to Head of Innovation and Development or Innovation and Development Manager.
- To maintain, uphold and ensure compliance with the standard of GLP – Good Laboratory Practices and ISO/IEC 17025.
- To follow basic current cGMP (current Good Manufacturing Practice) guidelines.
- To conform to ISO 9001:2008 directives included but not limited to policy and procedures. Strictly adhere to all necessary calibration requirements within all lab operations.
- To ensure standards and reagents are stored in the proper conditions at the required quantities and laboratory instrumentation such as HPLC, FTIR, UV- Visible spectrophotometer, dissolution testers are calibrated.
- To develop, control, and maintain the Lab Scope and all associated lab documentation and procedures. This includes managing all logbooks for instrumentation, ensuring accurate input and regular updates.
- To develop and update existing preventive maintenance programs to maximize equipment uptime, as well as raising the necessary purchase requisition to ensure continuous and efficient work output.
- To lead the resource planning for equipment, purchase and maintenance, chemicals/reagents, column & reference/working standards, recruitment of new staff, budget planning and control.
- To recognize problems with analytical instrumentation and troubleshoot/assist (with the help of Pharmaceutical Scientist or Innovation and Development Manager) or organize necessary external party in subsequent repair(s).
- To plan the resources required for method development and validation, as well as other analytical testing, to achieve the timeline of NPD set.
- To perform qualitative and quantitative chemical and physical analysis of raw materials and finished products.
- To check, verify and interpret raw data produced by the Analytical Team.
- To lead and oversee the I&D Analytical Team for method development and validation activities.
- To release and/or modify the specification and work instruction of test method for raw materials, intermediates and finished products.
- To plan, coordinate and review the testing results of stability study for new product development and improvement projects.
- To ensure all Chemists and Lab Technicians document all relevant daily activities. This includes reviewing the logbooks, registers, raw data and technical documentations (such as test method, validation protocol or report) in support of regulatory filings.
- To determine the measurements of uncertainty of laboratory instrumentation.
- To lead out of specification and/or out of trend investigations.
- To initiate and ensure the success of method transfer of newly developed method from I&D to QC Laboratory.
- To participate in internal and external audits and compliance inspections.
- To review product CoA (certificates of analysis) for accuracy and conformance, as well as maintaining CoA documentations.
- To update internal clients including Innovation & Development, Product Pipeline, Technical Services, Regulatory Affairs, QC Laboratory on the progress of analytical method development and validation, stability study and other analytical testing required.
- To develop the I&D Analytical Team by identifying training needs and training plan to ensure lab competency. This includes necessary the scheduling of necessary training on new approved tests/methods.
Minimum Requirements:
- Bachelor Degree in Science, preferably chemistry related discipline or Bachelor Degree in Pharmacy with minimum five years of working experience as chemist in a pharmaceutical testing laboratory.
- Able to demonstrate good leadership, as well as excellent communication.
- Membership of the Malaysian Institute of Chemist (IKM) or equivalent organization is preferred.