Job Summary
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* As a Technical Transfer Specialist, you will be responsible for leading technical activities for commercial manufacturing processes at External Partners. This includes authoring change control documents, improving processes, and analyzing performance.
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Key Responsibilities:
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1. Develop standardized work processes in partnership with Operations, Quality, and External Partners to ensure compliance with GMP requirements.
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2. Provide on-site support at External Partner locations to ensure Commercial and Technology Transfer Person-In-Plant Activities are executed smoothly.
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3. Maintain External Partner readiness for routine inspections and new product introductions or transfers, collaborating with Operations, Quality, and Regulatory teams.
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Requirements:
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* Bachelor's degree in Chemical/Biochemical Engineering, Pharmaceutical Science, Chemistry/Biology, or related field.
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* 4/5 years of experience in drug substance technical transfer, with a minimum of 4 years post-bachelor's degree experience in GMP functional areas.
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* Strong communication and teamwork skills, with proven expertise in biologics drug substance upstream and downstream operations, analytical testing, and process development.
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* Ability to manage projects and meet deadlines independently.
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* Statistics experience, including proactive process analysis and continuous process verification.
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* Experience in deviation management, change control, equipment support, and project management.
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