The position is a technical leadership role, reporting to the Director, Chemical Commercialization and Technical Operations, External Manufacturing Technology. The Technical Lead will be responsible for the management of the technical interface between Merck and External Partners (EP) for API and Intermediates. The technical lead will provide process support to External Partners in the External Manufacturing (ExM) Focused Factory to resolve production issues, evaluate and manage process change requests, proactively assess and manage process/technical risks, and provide guidance on process improvement and capacity optimization. The individual will lead and execute technical transfers to and from External Partners, along with validation strategies.
• Functions independently with minimal oversight, leads technical teams, and provides coordination and communication on assigned EP technical issues.
• Partners effectively and leads the interface with Merck Research Laboratories (MRL) groups (Process Chemistry, Chemical Engineering R&D, Analytical R&D), as well as other groups in GSTC (Supply Analytical Sciences, Center for Mathematical Sciences, Material Sciences) to drive Commercialization 4.0 and ExM strategies in the Focused Factory and region
• Executes technical transfers, provides on-going support to External Partners to resolve manufacturing issues, and develops and leads the execution of plans to meet capacity needs.
• Collaborates with Focused Factory teams and others to facilitate supply of products from EPs with an End-to-End mindset.
• Executes technical due diligence assessments at potential EP’s.
• In concert with the Focused Factory team and other key functions, ensures that EP's are inspection ready at all times.
• Provides a single point of technical contact to assigned EP's in Focused Factory and coordinates with impacted (downstream and upstream) MSD sites and External Partners.
• Demonstrates consistently a strong compliance and EHS mindset in driving excellence in supply performance in the Focused Factory
• Provides expert consultation and review of chemical manufacturing technical matters.
• Provides a 'calibrated' technical review of EP process change requests and deviation reports.
• Understands the true regulatory requirements and partners with Operations, Quality, Regulatory and the EP in applying efficient ways to meet these requirements.
• Based on calibrated oversight model, minimizes duplication of efforts between EP and MSD systems.
• Partners with EP's to achieve business goals and to establish a common culture that benefits both Merck and EP
• Partners with Commercialization and Analytical Development members as needed to ensure a smooth transition of outsourced intermediates and API from Commercialization to EM
• BS/ MS / Ph.D in in chemical/biochemical engineering, pharmaceutical science or chemistry or related fields
• Minimum of 7 years of post-BS experience, including manufacturing experience in the areas of pharmaceutical process production, with demonstrated experience in process start up, process optimization, and technical transfer
• Experience in biological manufacturing including fermentation, chromatography, and downstream purification is a plus.
• Experience in leading technical teams in the areas of process development / commercialization / tech transfer / supply of API products
• Flexibility and the ability to work independently, with excellent organizational skills.
• Strong MSD Leadership attributes including a global mindset, an end to end supply chain view, ability to collaborate across functions and geographies and multi-task effectively, strong interpersonal and communication skills, ability to establish and maintain strong working relationships with technical, quality and operations leaders in the internal and external network
Job: Chemical Engineering Job Title:Assoc. Dir, Engineering
Primary Location: APAC-SG-Singapore-Singapore
Employee Status: Regular
Number of Openings: 1
Company Trade Name:MSD
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