Lead Manufacturing Expert
1 day ago
We are seeking a highly skilled and experienced Lead Manufacturing Expert to join our team at Takeda's Singapore biologics manufacturing facility. As a key member of our operations team, you will play a critical role in ensuring the smooth execution of our manufacturing processes and maintaining the highest standards of quality and compliance.
Key Responsibilities- Support and coordinate routine GMP manufacturing life cycle and day-to-day operational activities associated with products and process equipment.
- Provide lead key initiatives, including continuous improvement, validation, and CAPEX activities.
- Work hand-in-hand with shift teams to ensure adherence to the production plan and resolve issues as required.
- Act as a subject matter expert during audits, explaining and walking through specific process operations or investigations.
- Carry out deviations investigations in the GEMS system, including product impact assessments and implement CAPAs.
- Be a change control owner in the CCMS system, if applicable.
- Maintain recipe configuration management documentation, if applicable.
- Carry out material support activities, including liaising with MLCM or vendors to address material issues, if applicable.
- Develop and implement CAPAs arising from audits.
- Inform management of events impacting production schedule.
- Propose and review document revisions.
- Carry out work in a safe manner, notifying management of safety issues and risks.
- 7 years of relevant experience in the biotechnology or pharmaceutical industry.
- Excellent self-motivated team player with hands-on attitude and excellent communication skills.
- Able to work on odd hours as required.
- Good understanding of cGMP manufacturing aspects and hands-on manufacturing experience.
- Excellent technical writing skills, including Electronic Batch Management (EBM), Batch Records (MBRs, MFRs), and Standard Operating Procedures (SOPs).
- Good communication and presentation skills.
- Ideal candidate will be Green belt trained/certified and possess good understanding of LEAN and Six Sigma concepts.
- Critical thinking skills.
- Full awareness of current Good Manufacturing Practices (cGMP).
- Proficient documentation skills and computer skills, including Microsoft Excel/Word/Powerpoint.
- Good time management and team coordination skills.
- Ability to work in a matrix environment.
- Understanding of requirements from support functions and their capabilities.
- Experience as a system user of business systems such as C3ME, XFP, and Trackwise.
Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. We are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do.
We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
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