Job Description Summary
As a CMC development specialist, enhance Japan’s CMC development strategy by offering scientific and technical support to global/local CMC development teams and other departments, while keeping up with the latest technological advancements.
Job Description
Key Responsibilities
Act as a subject matter expert (SME) on CMC development within the TRD submission team, from initiating clinical trials through NDA filings.
Understand CMC development strategies for assigned projects and provide scientific and technical insights on potential risks, particularly for novel and complex elements.
Develop expertise in new modalities and technologies, including formulations, process development, manufacturing and control strategies, and provide expert consultation.
Provide input on Japanese requirements and expectations, and collaborate with local and global stakeholders to address scientific and technical challenges.
Review and prepare documents, protocols and reports required for Japan filings and launches, including J-NDA Module 3 and J-QOS.
Act as a CMC expert supporting other functions, including knowledge sharing, data generation for marketed products, and collaboration with clinical and commercial stakeholders.
Maintain global and local development-related SOPs and manuals, and perform QC activities for investigational medicinal product (IMP) release in Japan.
Ensure compliance with company requirements and, for manager-level positions, mentor associates and lead activities within PHAD Japan.
Background
Education: University or graduate (master's) degree (or higher) in pharmacy, science, engineering, or other technical fields.
Essential Requirements
University or graduate (master’s) degree or higher in pharmacy, science, engineering or another technical field.
Expertise in at least one CMC area, such as drug substance, drug product, formulation development, process development, setting control strategy or analytical science.
Basic knowledge of Japanese pharmaceutical regulations.
Native-level proficiency in Japanese.
Proficiency in reading and writing in English.
Desirable Requirements
Preferably 5+ years of experience in the pharmaceutical industry.
Intermediate business-level speaking and listening skills in English.
* You do not need to be familiar with all the modalities or technical area mentioned in the Major Accountabilities section. If you have specialized skills in any CMC area and a strong motivation to learn about other technical field, we encourage you to apply.
Language skill: Native-level proficiency in Japanese is required, proficiency in reading and writing in English is necessary, and intermediate business-level speaking and listening skills in English are preferred.
* If the candidate possesses exceptional CMC skills, the English language requirements mentioned above can be flexible and open to discussion.
Benefits and Rewards
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Commitment to Diversity and Inclusion
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Accessibility and Accommodation
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Additional Information
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Skills Desired
Continual Improvement Process, Master Data, Materials Management, Materials Requirements Planning (MRP), Production Planning, Supply Chain Management (SCM), Supply Chain Planning (SCP), Technical Requirements, Warehouse Management System (WMS), Waterfall Model
