Requirements: • BS/BA in biotechnology, chemical engineering, biological sciences, or similar scientific discipline and 12+ years of relevant experience • MS/MA in biotechnology, chemical engineering, biological sciences, or similar scientific discipline and 10+ years of relevant experience • PhD in biotechnology, chemical engineering, biological sciences, or similar scientific discipline and 8+ years of similar experience noted above • Working knowledge of GMP manufacturing environments and quality systems • Experience authoring and executing technology transfer plans, protocols, and reports • Understands process development, transfer, and validation and risk management principles • Experience supporting external manufacturing partners (CDMOs) • Familiarity with ICH Q8/Q9/Q10 guidelines • Advanced understanding of process or product development strategies as well as current techniques and literature • Good knowledge of cross-functional requirements related to drug development • Ability to lead teams and direct development programs • Excellent at strategic planning • Maintains substantial knowledge of scientific principles and theories and possesses intellectual mastery of one or more scientific areas • Acts as a technical lead on various projects • Applies understanding of the teams place in the larger organization, and discusses changes, progress, and issues as they relate to other areas • May utilize working knowledge of other related disciplines to provide solutions to a wide range of difficult problems • Ability to work as part of and lead multiple teams • Good leadership, mentoring skills, and abilities typically leads junior levels and/or indirect teams • Excellent interpersonal communication, problem-solving, and analytical thinking skills • Sees broader picture and longer-term impact on division/company • Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency • Excellent project management, strong project leadership skills • Ability to influence all levels of the organization and external resources. Your Contributions (include, but are not limited to): • Lead and support technology transfer activities from R&D to GMP manufacturing • Develop, execute, and maintain technology transfer plans, timelines, and deliverables to ensure successful process transfer • Serve as the technical subject matter expert for process and manufacturing technologies during transfer and scale-up • Author, review, and approve technology transfer documentation, including protocols, reports, gap analyses, and risk assessments • Provide technical oversight and troubleshooting support during engineering runs, clinical trial manufacture, and validation • Ensure all technology transfer activities comply with GMP, ICH, and internal quality system requirements • Manage interactions with external partners, vendors, and CDMOs, including technical discussions and issue resolution • Significantly contributes to the development of department strategies and policies • Plans and manages projects and project teams • Represents the broader department and the function at cross-functional teams • Maintains accountability for deliverables including production plans for development projects • Leads risk assessments to support project advancement • Independently designs, plans and executes complex activities towards the goals of one or more development projects to support preclinical through commercial activities • Proactively identifies process or product challenges and leads necessary optimization activities including trouble-shooting experimentation • Creates and implements novel ideas to improve product quality, product stability, manufacture consistency, or to achieve cost effectiveness • Provides input into CMC regulatory documentation and supporting work • Builds and enhances internal and external professional relationships • Leads and mentors lower-level scientists and/or team members • Other duties as assigned.