Principal Scientist Job - Singapore
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MSD is currently seeking an exceptional individual for a technical leadership position within the Supply Analytical Sciences (SAS) - Analytical Chemistry in Development and Supply (ACDS) organization located in Singapore. The successful candidate will be joining a group of innovative scientists with broad deliverables ranging from API and Drug Product analytical troubleshooting to driving lead-time reduction and efficiency gains to ensure MSD’s success in Asia Pacific (AP) Region. The incumbent is expected to lead and oversee multiple external sites (CMO’s) with the focus on building strong compliance posture in routine analytical testing. The individual will interact closely with internal MSD sites and the CMOs in Merck Manufacturing network in identifying issues/gaps and implementing solutions, and troubleshooting laboratory test methods and workflows as well as material for ensuring compliant, robust, and responsive supply. The individual will initiate and lead strategic initiatives related to technical strategies, compliance, and/or business improvements. The individual will have a deep understanding of the regional regulatory and business environment and the needs related to API and Drug Product development, GMP compliance in commercial manufacturing and data integrity. The individual will also be responsible for technical training of staff, as needed, on analytical techniques, problem solving and data integrity. In addition, the incumbent will keep up with API and Drug Product regulation changes and facilitating central development group to make adjustment to MSD product development strategies.
The position will report into the SAS AP Regional Lead. A strong technical background with a superior problem solving skill set, exceptional leadership abilities, strong knowledge of cGMP and Data Integrity are considered essential, as these will be key attributes necessary to facilitate the ability to influence change in efforts to realize MSD’s vision.
• Ph.D. degree with 6+ years or BS/MS degree with 12+ years of pharmaceutical experience.
• Author analytical procedures, method development, validation and transfer protocols and reports, technical reports, experimental designs, and regulatory submission documents, etc.
• Perform investigations with strong technical troubleshooting skills and assist in developing/implementing CAPAs.
• Provide documentation/technical input during inspections and audits (Regulatory and Internal) and have a working knowledge of data integrity and recent industry trends.
• Identify and champion continuous improvement for the existing workflows.
• Have working knowledge of API and Drug Product development and commercialization and understand the needs related to commercial quality control.
• Have working knowledge of developing various analytical techniques (e.g., chromatography, dissolution, spectroscopy) and product specification to support drug substance and drug product development and registration.
• Have working knowledge of the process by which the products are brought to market.
• Demonstrate strong collaboration and influence skills with cross-functional partners both internally and externally.
• Have experience working with CMO’s and CRO’s.
• Have working knowledge of CMC filing requirements.
• Demonstrate strong verbal as well as written communication skills and ability to work in an interdisciplinary team environment.
• Demonstrate strong interpersonal skills with flexibility and sensitivity in dealing with different cultures.
• Self motivated to take ownership and accountability of issues and drive them to completion.
• Ability to speak up and raise issues and help to drive to resolution.
• Ability to quickly adapt to changes and develop appropriate plans for managing risks.
Job: Chemistry - Science & Technology Job Title:Prin. Scientist, Chemistry
Primary Location: APAC-SG-Singapore-Singapore
Employee Status: Regular
Number of Openings: 1
Company Trade Name:MSD
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