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Job Description- Tech Transfer LeadThe tech transfer lead is a key position who will lead development and execution of scale/up/optimization and technology transfer for new formulation products. He/She is an influential team leader within multiple customer facing project teams using a standard methodology/procedures to successfully transfer complex processes into USP and/or DSP GMP manufacturing from process development and pilot scale facilities.Key Accountabilities and Duties:
- Define, develop and communicate strategies for assuring robust process development and tech transfer activities with R&D and manufacturing insights.
- Author, review, and/or approve site technology transfer documents such as tech transfer plans, risk assessments, study protocols, reports, batch records, sampling protocols, CAPAs, change controls, standard operating and business procedures, policy and instructions, etc.
- Facilitates the risk assessment process by coordinating with subject matter experts to assist in the generation of key content to support knowledge management processes for projects.
- Contribute to regulatory filings, as required, including reviewing and authoring CTD sections and peer review of submissions.
- Responsible for working with R & D groups in optimizing/establishing process parameters (with commercial processes in mind) within the design space to evaluate/implement opportunities for process improvements.
- Accountable for the management of technical risks associated with process transfer, identification & introduction of new raw materials for pilot and production scale batches and work cross functionally to ensure communication of all critical process and technical information to meet the required deadlines/customer outcomes.
- Communicates complex concepts and influences diverse groups of stakeholders (sometimes with divergent views) across and outside the SU and RU to create an environment that is receptive to transfer and enables the transfer of specific technologies.
- Contributes to the immediate resolution of identified manufacturing process issues through use of knowledge and experience, leading technical investigations to ensure continuous improvements are made to the GMP manufacturing processes and operations. Will work with SMEs to develop knowledge base, deepen process understanding and advise as needed junior level team members on specific technical problem resolution through sharing key knowledge.
- Proactively anticipate, evaluate and resolve technical challenges within area of expertise. Is self-managed in preventing deviations in unit operations including interaction and strong communication with both internal and external team(s).
- Understands and looks to introduce new technologies and how they may be applicable to process innovation, cost or yield improvement.
- Interface effectively with analytical, formulation, microbiology, device, regulatory, operations, quality and other essential functions.
Minimum Required Qualifications/Skills:
- PhD +5 year or Master +7 year or BS +10 years of relevant experience in pharmaceutical development, manufacturing, tech transfer activities/projects
- Detail and plan oriented
- Demonstrated knowledge in DP manufacturing in GMP environment (knowledge of USP and/or DSP operations considered as an asset)
- Ability to technically understand complex non routine unit operations with a proven track record of successful technical transfer expertise.
- Has a deep understanding of manufacturing processes
- Able to trouble shoot/recommend the solutions to resolve the technical issues with manufacturing equipment.
- Requires understanding of scientific principles, operational aspects of production equipment, automation control systems, processing requirements and any related procedural requirements
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