Manager, Global Technical Operations, API Job - Singapore
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The GTO Manager has primary responsibilities for oversight of the technical team facilitating introduction of new products to the site, providing technical expertise on the manufacture of all drug products on site and/or regionally and transferring drug products to other facilities. In collaboration with site supporting functional groups, the GTO Manager provides technical guidance/direction on deviations, investigations and customer complaints and additionally coaches the GTO engineers/chemists in standard tools used in these investigations.
The GTO Manager leads and provides subject matter expert (SME) technical guidance to the site and regionally in process improvement activities, deviations and contributes to global technical networks to share site and regional experiences. In addition, the GTO Manager is also responsible and accountable for establishment and oversight of career development plans for their staff.
Coaches and mentors the GTO Engineers in new product introductions to the site. Also leads new product introduction to the site and/or regional sites through leadership of site technology transfer team, responsible for (but not limited to) process and equipment comparisons, raw material introductions, process development studies, cleaning processes development and validation, process fit and gap analysis.
Provide oversight on technology transfer activities, including but not limited to equipment qualification, process qualification, cleaning validation and associated site regulatory filing activities. Expected to have the in-depth expert knowledge of the MSD Quality Systems, especially on Chapters 3, 13, 17 and 25, and the principles of Quality by Design (QbD) in relation to the development of pharmaceutical products. The incumbent are also 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.
Supports routine supply manufacture by providing on going technical support to the IPT during manufacturing and cleaning. Expected to be the lead in identifying and prioritizing opportunities for continuous process improvements based on feedback from proactive monitoring in the plant e.g. through Proactive Process Analysis (PPA).
Expected to also positively influence site partners (IPT, Quality) on process improvements, remediation plans and introduction of proactive monitoring of the various manufacturing processes.
Management of GTO laboratories to good laboratory practices are adhered to. Ensure activities carried out in the laboratories are done in accordance with SHE requirements and aligned to site SOPs.
Provides and coaches/mentors the GTO Engineers in areas related to equipment and manufacturing/cleaning processes in response to deviations and atypical events to determine the root cause and resolve issues systematically. Expected to be the SME in specific technical knowledge related to process engineering, scale up, designing experiments etc.
Capable to provide regional technical support in new product transfer to other sites, investigations to deviations and process improvement activities to improve robustness as well as technical training to build capabilities at site or regionally. Expected to leverage on industrial practices to innovate current practices and processes, lead the implementation of new technology or practices to the site and regionally.
Leads collaboration and sharing of best practices with internal/external SMEs (e.g. CPDC, PCT, Sterile council, ADC, CMSE and other groups within the GSTC network.
Complies with all divisional and site-specific policies, guidelines and procedures. Making safety adherence as a pre-requisite to employment.
Demonstrates and promotes safety, health & environment (SHE) leadership behavior, ensuring that all activities are carried out in accordance with SHE requirements. Actively participates in GEMBA safety walk, HazOp. Speak on process safety and lead by example, GTO safety commitments. Where applicable, writes and reviews SOPs, gap analysis and Job Aids for GTO subsystems in compliance with divisional and corporate policies and guidelines. The GTO Manager is also expected to be influential in divisional or above site initiatives to provide the site feedback to align with divisional teams on changes to divisional policies, procedures that impact the site.
Demonstrate leadership behavior in alignment with MSD leadership standards (Individual Contributor/Manager), specifically on Fostering Collaboration, Building Talent and Drive Results.
Practise Inclusion as the How and possess a strong MSD Production Systems (MPS) mindset
Leads personal career development with manager assistance through annual Performance Management Process (PMP), Employee Development Plan (EDP) and career mapping.
Primary oversight for the development of engineers through administration of the individuals’ objectives, EDP and career mapping.
Any other duties as assigned by the Supervisor.
- Bachelors, Masters or Ph.D. degree in a technical field, including Chemical or Mechanical Engineering, Chemistry or Pharmaceutical Sciences
- Minimum 5 years technical experience in related pharmaceutical manufacturing industry
- Minimum 1 year in supervisory position of professional staff previously, or demonstrated capability to successfully lead large teams in complex projects.
- Expert knowledge of core technology/unit operations relevant to active pharmaceutical ingredient, Biotech and/or Non-Sterile manufacturing
Job: Process Engineering Job Title:Mgr, Engineering
Primary Location: APAC-SG-Singapore-Singapore
Employee Status: Regular
Number of Openings: 1
Company Trade Name:MSD
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