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Works with cross functional team to facilitate NPI process fit; including batch record review, assistance with area engineer to ensure process fit within BU3 manufacturing suites, work with Tech transfer to produce standardized and efficient clinical batch record.
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Support or lead new process or technology transfer from internal and external partners into GMP manufacturing department including documenting tech transfer progress and authoring technical reports.
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Supports BU3 metrics and help establish meaningful KPIs to identify and enable continuous improvement in tech transfer and new product introduction. Proficiency with tech transfer process & familiarity with equipment & facilities validation.
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The Cell Culture Development organization within Operations leads the process development and tech transfer of cell culture processes for clinical manufacturing and commercialization of therapeutic proteins in the AbbVie pipeline.
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Develop and provide process-related training to MFG personnel and author training reports during tech transfer. Knowledge and direct experience in technical transfer and/or GMP manufacturing process and good documentation practices a plus.
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The Head of Downstream will work closely with the management team and MSAT (Material Science & Technology) teams to ensure the effective and efficient tech transfer of products and processes to the MFG11 Facility.
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Demonstrated proficiency in bench scale bioreactor, shake flask, and other culture systems for the optimization of cell culture processes. Builds strong relationships with other process and analytical development teams, Manfacturing Sciences and Technology, R&D, Manufacturing, Quality and Regulatory groups to develop and align strategy to develop AbbVie’s cell culture platform to improve efficiency, productivity, robustness and product quality.
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Knowledge of media/buffer preparation, cell culture or purification of biological drugs is required. Manages document review and approval for the operations group to meet project timelines. Working knowledge of safety, quality systems & current GMP as applied to equipment and process steps in area of responsibility is required.
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Experienced in method development, method validation, and tech transfer, particularly in a GMP environment. Not standard QC positions; candidates must be experienced in method development, method validation, and tech transfer.
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The Director of OTC, reporting to the Vice Provost for Research, manages a small team of tech transfer professionals and plays a crucial role in managing all aspects of WPI's intellectual property (IP) portfolio.
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Provide support in defining statistical design and analysis for process development, technology transfer, analytical development, process validation and re-qualifications, manufacturing, chemistry and microbiology laboratories, incoming QA, investigations, CAPAs, compliance, complaints process.
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Works with technology transfer team to incorporate new processes in the plant. Works with QA and Subject Matter Expert (Tech Ops or Process Sciences) to resolve exceptions. Familiarity with industrial automation (e.g., distributed control and PLC-based systems.
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