My client is a global name in the biopharmaceutical industry and is now seeking a Head of MSAT to support activities of GMP manufacturing operations globally and influence change and support business processes through cross functional interactions
- Global Name
- High Salary
- Senior Leadership role
- Align the department to achieve the site goals and communicate the needs of the department to the site management.
- Lead a team of Process Engineers/Specialists to provide MSAT support for cell culture or purification stages
- Work with technical experts from Manufacturing, Quality Assurance, Quality Control, and other departments towards successful pre-campaign preparation, campaign support and post campaign analyses.
- Forge strong relationships with manufacturing counterparts to serve as a natural extension of the manufacturing team.
- Ensure manufacturing training is appropriately designed for each product and provide necessary floor support to supplement pre-campaign training resulting in processes being executed accurately with minimal deviations.
- Develop basic understanding of other areas (ex. working knowledge of DSP for a cell culture manager) to enable broad technical discussions with customers during technology transfer, process support or investigations.
- Lead and develop team members to build a self-managing and high performing team.
- Develop and design technical process capabilities, testing and validation parameters and performance measurements.
- Author documentation for technology transfers, validation and technology development activities.
- Provide technical review of cGMP documentation, change control request, regulatory submissions, scientific reports and presentations.
- Masters/PhD in Biotechnology/Chemical Engineering/Bioengineering/Life Sciences or related studies.
- Minimum of 10 years' experience in pharmaceutical manufacturing, technology transfer and process development, validation, with at least 5 years in a people management role.
- Proven track record in cGMP operations in drug products, and in drug substances (preferred).
- Prior cGMP operations experience with cell culture or purification and a strong understanding of critical process parameters is required.
- Previous knowledge in mammalian cell Upstream and Downstream process validation essential and aware of current regulatory and industry standards & GMP guidance.
- Ability to adapt and respond to changing priorities to support manufacturing operations.
- Ability to think critically, and possess troubleshooting and problem solving skills.
- Knowledge in use and application of statistical tools and methods to support process validation and experimental data analysis.
- Proficient in MS Office Suite (Microsoft Word, PowerPoint, Excel).
- Able to work independently, self-starter, self-motivated and task oriented.
- Good communication skills and able to openly communicate and escalate any relevant issues.
- Experience in developing, leading, and maintaining high performing team, whilst being a strong team player to work with both internal and external stakeholders.
Please send your resume in WORD format by clicking the apply button below or contact Abhik Damani on +65 6701 1527 for a confidential discussion. Please note that only short-listed candidates will be contacted. CEI Reg. Number R1544061 (Abhik Damani).