Head of MSAT

Location: Singapore
Job Type: Permanent
Specialisation: Engineering & Manufacturing
Salary: S$10000 - S$12000 per month
Reference: BBBH9375_1623405324
Contact: Abhik Damani
Email: email Abhik

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

Responsibilities:

  • 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.

Requirements:

  • 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).