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Job #03217

About our client Our client is a clinical-stage biotechnology company and a leader in developing tissues derived from a patient's own cells. The company has licensed over 60 US and international patents and patent applications from Harvard's Children's Hospital, Boston and MIT. Position Location Senior Manufacturing Technology Specialist Pennsylvania Salary Highly competitive package, commensurate with experience Responsibilities 1) Liaise with/and support members of the Science and Technology Organization in designing/implementing processes/analytical methodologies that meet the technical requirements of commercial operations 2) Work with stakeholders to develop, create and execute strategies for transferring analytical methods for commercial site implementation 3) Liaise with stakeholders to develop/create protocols that validate analytical methods at the commercial site(s) 4) Work with stakeholders to create appropriate training programs for technical staff and provide detailed training at commercial site(s) 5) Liaise with Quality Team to provide technical expertise to technical problems encountered with analytical methods such that loss of the product is avoided 6) Manage junior staff Requirements 1) Ph. D. in Biochemical/Biomedical Engineering/Biotechnology/Cell Biology or a related field (or MS if supplemented with appropriate length of relevant experience) 2) Minimum 5 years of industrial experience related to job duties 3) Experience in high-content analysis a plus 4) Prior experience in developing/transferring analytical methods from development into commercial operations as well as statistical analysis techniques 5) Knowledge of cGMPs, cGTPs and analytical/bioanalytical method qualification or validation practices 6) Excellent technical skills and practical working knowledge of a variety of bioanalytical techniques like immunocytochemistry, flow cytometry, PCR, qPCR, RT-PCR as well as imaging systems and analysis 7) Technical skills in basic cell culture 8) Excellent communication skills (written and oral) 9) Ability to design technical and experimental procedures/protocols within the area of subject expertise 10) Ability to solve complex technical problems based on data input, current technical knowledge and reasoning skills acquired through experience