Information relating to AS&T CMO Manager – Michael Page, published on January 22, 2016 at 11:58PM.
The AS&T Manager leads the analytical science and technology CMO activities and work closely with the global AS&T organization to develop strategy for analytical technology at contract manufacturing organization to ensure best pratice and compliance for analytical methods, validations, transfers, release and stablity data as well as associated quality systems.
My client is the second largest pharmaceutical company in the world by revenue. The company’s products include prescription medication, vaccines, and consumer health products, though it manufactures products for many different therapeutic categories within these broad spaces.
- Provide analytical oversight at the contract manufacturing organizations to ensure that all analytical methods are state-of-the-art and in compliance with regulatory expectations.
- Direct and oversee analytical method transfer and analytical services performed by third party contract laboratories including any outsourced stability programs; ensure the follow-up stability program is performed according to regulatory requirements
- Work with the global AS&T Central Labs to ensure that analytical methods are adequately developed, validated and maintained. Develop and implement analytical method validation plans, if required.
- Ensure that adequate and timely analytical support for investigations (e.g. deviations, complaints) and troubleshooting is provided. Assist the CMO units with preparation, management and follow up of internal audits and Health Authority inspections. Review and monitor action plans for correction of audit observations.
- Participate as needed and provide analytical support in BD&L, Marketing, Legal, Tech Ops CMO and Regulatory Affairs team meetings on new commercial BD&L projects and new product launches.
- Review and implement global SOPs within the local AS&T CMO team
- Manage assigned financial responsibilities (external project spend and/or travel budget)
- Focused expertise in analytical characterization and instrumentation is critical to understanding the viability of approach used at CMO laboratories.
- 5-10 years in the pharmaceutical industry with operational experiences in an analytical laboratory.
- Good knowledge in analytical technology.
- Must have experiences and undestanding in advance analytical chemistry in implementing laboratory methodology, systems and equipment.
- Ability to lead and influence stakeholders as to decision related to analytical chemistry, compliance and product launch.
This is an excellent opportunity to progress the next stage of your career as the AS&T CMO Manager. Our client, a well established pharmaceutical company will provide a rewarding experience for this crucial role.
To apply online please click the Apply button below. For a confidential discussion about this role please contact Ray Tay (Lic No: R1107939) on +65 6416 9836