Work Schedule
Standard (Mon-Fri)Environmental Conditions
Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)Job Description
To oversea a team of AD scientist for method development/optimization, validation, transfer, Daily/weekly planning and execution of experiments.
To provide analytical expertise and technical support for all phases of drug development to support the introduction of new products, process development, plant investigations and regulatory activities.
To lead analytical projects for the introduction of new products to the Site, including method assessment, method development, validation/qualification and transfer.
To provide lead technical and analytical support to the team resolution of operational, technical and analytical issues within the Analytical Development (AD) laboratory.
To promote and supervise laboratory GMP / Safety within the Analytical Development (AD) group such that the AD laboratory is maintained as an inspection ready facility.
To coordinate with client, project management, manufacturing, QC and PDS team and share periodic update on assigned projects.
To actively participate in the development of the AD group as a centre of excellence.
To actively participate in AD group capability building and drive competency development
To Creating schedules for team members and providing feedback on their performance
To motivates team to do their job timely and efficiently.
To participate in regulatory and customer audit.
To support AD manager on budgeting and recruitment.
Laboratory GMP Compliance
- Obtain a working knowledge of all relevant site and analytical Standard Operating Procedures (SOPs)
- Maintain laboratory notebooks and proforma testing sheets in compliance with GMP requirements
- Carry out calibration of equipment and analytical balances as required.
- Ensure that the validation/calibration documentation associated with instrumentation is appropriately signed off before use.
- Maintain good housekeeping standards. Carry out laboratory housekeeping audits and assigned self inspections in accordance with defined schedules. Complete assigned actions in a timely manner and report any deficiencies.
- Participate in both internal and external audits as required.
- Maintain individual training records on an ongoing basis.
- Participate in the training of team members as appropriate.
- File all data as appropriate and facilitate appropriate archiving.
Technical Support or Troubleshooting for Existing Products
- Provide technical data/opinion to both internal and external customers where required.
- Participate in cross-functional meetings/teleconferences (internal and external) as appropriate.
- Participate in deviation investigations as required.
