Manager Manufacturing Programs

Manager Manufacturing Programs Amgen Singapore Manufacturing HOW MIGHT YOU DEFY IMAGINATION? Amgen is one of the world’s leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring a Manager Manufacturing Programs I in Amgen Singapore Manufacturing. Live What you will do Amgen Singapore Manufacturing is responsible for drug substance manufacturing and release of Amgen’s commercial product using innovative manufacturing platforms and technologies. Reporting to the Senior Manager, this Manager position is primarily responsible for providing process and New Product Introduction (NPI) support for multiple biologics products and process equipment. The scope includes equipment preparation, buffer/media batching, cell culture, purification, drug substance bulk fill, and analytical operations etc. The role includes the supervision and development of professionals tasked with managing, planning and implementation of changes, driving deviation investigations, resolving process interruptions, etc. This role requires highly cross functional interactions with key site functions to ensure success in production and release performance. It offers abroad exposure to all key aspects of GMP manufacturing as well as tactical and strategic teamwork within the extended worldwide manufacturing network. Main Responsibilities : Responsible for management and oversight of manufacturing technical support staff Direct production interruption investigation and serve as escalation point for resolving process/equipment related issues Build system and capabilities to drive short and long-term improvements to process reliability and efficiency Escalate and address risks and opportunities found in manufacturing facilities, equipment, processes, and procedures Approve master electronic batch records and procedures describing the manufacturing operations to suit production needs Build and maintain a robust support function to perform assigned quality management activities such as deviation, change control, CAPA management Ensure on time in full disposition performance by delivering deviation, change control components of release Present key investigations and quality management system records in all site regulatory inspections Drive/support site wide technical and non-technical continual improvement initiatives, programs and projects to increase production and disposition agility Coach, mentor and/or cross train staff within core technical areas. Drive forward employee engagement activities to differentiate site/company as a great place to work All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodation for additional tasks and responsibilities. Win What we expect of you Basic Qualifications · Doctorate degree OR · Master’s degree and 2 years of Quality or Operations related experience OR · Bachelor’s degree and 4 years of Quality or Operations related experience OR · Diploma and 8 years of directly related experience · In depth technical knowledge of biopharmaceutical upstream or downstream processing and broad understanding of related disciplinary areas · Demonstrated track record in driving for results in regulated industries · Able to communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms · Strong leadership skills, decision-making, problem-solving abilities · Demonstrated ability to work under minimal direction · Able to adapt to changing business needs and operational requirements · Resolve issues and influence across support organizations · 1 to 3+ years of supervisory experience preferred Your selection for this role will be subject to fulfilling the medical requirements of this job scope. If so, you will be informed of the medical check(s) that you may need to undergo. All medical related expenses incurred from this medical check shall be borne by the company. Thrive What you can expect of us As we work to develop…