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Job #03096

About our client Our client is a rapidly growing biotech headquartered in Massachusetts that is focused on the development and commercialization of various immunology disease therapeutics. The company has an experienced management team, a robust pipeline and an empowering corporate culture that is focused on the professional development of its employees. With a solid pipeline of products, this is an exciting opportunity for the right candidate to join a rapidly growing company. Position Location Senior Scientist Cambridge, Massachusetts Salary Highly competitive package, commensurate with experience Responsibilities 1) Operate and maintain laboratory equipment 2) Transfer method development/optimization programs into development 3) Prepare appropriate documentation 4) Present work at meetings 5) Provide scientific leadership and training for other staff members 6) Work closely across R & D and contribute to a dynamic work environment where teamwork is essential 7) Use all available modern analytical techniques to develop methods and assays for the characterization and quantification of complex peptide mixtures and their related by-products 8) Contribute to in-house method transfer activities and with vendors for external method development, qualification and/or validation activities 9) Review stability programs and oversee external release-testing for clinical trial materials 10) Perform analytical activities to support the preparation of APIs and drug products (as per cGMPs and Q7A ICH guidelines) 11) Track relevant data accurately 12) Perform in-depth analysis as well as deliver written protocols, method development reports and qualification/validation reports 13) Perform other duties as assigned Requirements 1) Relevant degree in Analytical Chemistry, Pharmaceutical Chemistry or related discipline with either a Ph. D. and 5+ years of experience or MS with 7+ years of experience 2) In-depth experience in pharmaceutical development activities surrounding Phases I, II and III in the area of peptide polymers preferred 3) Experience in pharmaceutical development activities including participation in cross-functional development teams 4) Expertise in chromatographic analysis (HPLC) and mass spectrometry (LC/MS, MALDI, etc.) 5) Proven method development experience, GMP/GLP testing, method transfer skills and validation skills 6) Excellent writing skills 7) Experience in delivering protocols, method development reports and validation report 8) Good communication skills (written and verbal) 9) Excellent problem-solving skills with hands on approach to diffusing critical bottlenecks (i.e. troubleshooting method issues)