MAIN RESPONSBILITIES (Priorities to be aligned with direct supervisor)
Coaches and mentors, the PTO Engineers / Chemists on their technical support activities related to commercialization and manufacture of drug products on site. Key activities include but are not limited to:
New product introductions , technology transfer activities
Deviations and customer complaints investigations
Proactive process analysis and monitoring
Process and cleaning related activities (such as equipment qualification , validation , verifications , monitoring , CPV, APR activities)
QMS topics especially for PTO owned topics
Audit/ Compliance support
Product portfolio
Real time problem solving (RIPS) for shop floor investigations
Statistical and problem-solving tools
Is conversant and able to coach in all technical support areas. Accountable for his/her teams in the respective IPT areas b y making results/issues visible, effectively managing the execution of the activities and addressing issues systematically.
Expected to stay abreast of recent developments in major regulatory guidance issued by the FDA, EMA etc . , and proactively assess impact and changes required for the current operations.
Benefits
Paid time off
Additional Information
Job Description
JOB PURPOSE
The PTO Associate Director Engineering/ Chemistry (M2) ensures oversight , coaching of the technical team on their technical support activities related to the commercialization and the manufacture of all drug products on site. These activities include (but are not limited to) product and cleaning validations, technology transfer , audit/compliance support, process monitoring , product portfolio and new product introduction . The PTO Associate Director Engineering / Chemistry demonstrates advanced knowledge of the end-end supply chain and must work effectively within cross- functional teams in establishing priorities for the IPT and department. In addition , he/she provides technical guidance/direction for the PTO engineers/ chemists with the technical knowledge/ compliance knowledge/ essential skills needed for their technical supply support activities.
The PTO Associate Director is expected to build and develop his/her teams . He/ She will have people management responsibilities and is accountable for establishing the priorities and providing oversight of career development plans for their direct reports. In addition, he/she leads and provides subject matter expert (SME) technical guidance to the site and regionally in process improvement activities , investigations and contributes to global technical networks to share site and regional experiences. The PTO Associate Director Engineering/ Chemistry also leads continuous process improvement or strategic initiatives activities to enhance site performance metrics and provides expert knowledge to the site and across the our global company technical network (while leveraging on other site experiences/ knowledge) and continuously expands on personal expertise.
Merck · - Singapore - Singapore (50 Tuas West Dr), Singapore