AavantiBio is seeking a highly motivated Manufacturing Specialist to be responsible for coordinating activities associated with the transfer and implementation of our gene therapy processes at external manufacturing partners. The ideal candidate will be able to apply strong depth of applied manufacturing sciences and technical project management to deliver all manufacturing preparations to meet quality requirements while coordinating across internal and external stakeholders including Process and Analytical Development, Quality, Regulatory, and CDMO functions.
- Serving as accountable technical leader and functional representative within the CMC development team for one or more company assets.
- Supports all phases of the clinical manufacturing project life cycle including, CDMO evaluation, Scope of Work Input, technology transfer, clinical production campaign, deviation evaluation and investigation, batch disposition, and campaign conclusion and summary.
- Lead technical transfer of drug substance and drug product manufacturing activities into CDMOs
- Generate and/or review key technical transfer deliverables including Technical Transfer Plans, Process Flow Diagrams, Manufacturing Process Descriptions, Process Risk Assessments, manufacturing/campaign summary reports, and comparability assessments.
- Contributes to the development of manufacturing strategies for resolving complex issues related to new process transfers to manufacturing sites.
- Serves as Person-In-Plan (PIP) overseeing manufacturing operations at CMOs. Be present at CMOs & CDMOs to monitor execution of production and studies, as well provide technical guidance as needed.
- Review and/or approve of CDMO manufacturing documentation including manufacturing bill of materials, production master batch records, and executed production record review.
- Work in close collaboration with the CMO and Aavantibio development teams to support manufacturing investigations and change controls. Provide assessments of product and process impact and contribute to the identification of root cause and determination and development of appropriate action plans.
- Serve as a subject matter expert (SME) for one or more unit operations of the at scale process.
- Author key technical documentation supporting manufacturing activities including technical risk assessments, manufacturing protocols, campaign reports, and descriptions of manufacturing process and controls.
- Author supporting documentation for relevant CMC manufacturing content of various regulatory submissions as needed.
- Proactively identify and develop solutions to challenges faced within area of responsibility. Present options analysis to manufacturing leadership team and recommended path forward.
- General knowledge of process development and pharmaceutical manufacturing for biologics including cell culture, purification, and fill/finish operations.
- Working knowledge of GMP manufacturing, quality standards, and regulatory requirements.
- Experience in writing and revising protocols, procedures, reports and other process related documentation as necessary to support process scale-up, transfer, and implementation to cGMP manufacturing operations.
- Ability to troubleshoot and provide solutions to technical and logistical issues.
- Exhibits leadership behaviors including collaborating for results and developing/executing strategy both internally and with external partners.