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Subject: Senior Analytical Scientist in Bedford, OH - send resumes to dan.wienczkowski@rightthinginc.com

Dan Wienczkowski, ACIR, CIR, CDR, CSSR, PRC posted a job: Senior Analytical Scientist in Bedford, OH - send resumes to dan.wienczkowski@rightthinginc.com

"Senior Analytical Scientist – Product and Process Development (PPD) Location: Bedford, OH Responsibilities: - Responsible for technical leadership of all analytical development activities within a project team including technical direction, training, and mentoring of more junior staff - Initiates, designs, accurately interprets, troubleshoots and completes non-routine procedures independently and efficiently - Proposes, gains support for and implements ideas from knowledge of analytical development and the drug development process - Proposes, evaluates and implements new technologies; independently applies scientific principles, technology and regulatory knowledge; - Performs literature searches, attends scientific meetings, and keeps abreast of literature relevant to analytical science in product development - Responsible, in collaboration with management, to develop and track project timelines and assumes departmental responsibilities for projects when necessary. - May deliver updates to senior level management in context of overall project goals - Effectively communicates and defends own work, orally and in writing, at team meetings, in technical documents, and to external partners - Participate in cross departmental project teams as required - Generate documents in support of Regulatory submissions, and may author portions of CMC section of submissions. - Responsible for the development and evaluation of proposed analytical methods, method validation, and method transfer. - Design studies related to method validation, transfer, and stability testing of new development projects - Responsible for analytical support for formulation development - Responsible for de-formulation activities to support generic dosage forms, in collaboration with other PPD staff - Consult and lend expertise in analytical science concepts to other scientists and groups. Requirements: - PhD with 5+ years of relevant experience preferred, Master’s Degree with 9+ years experience in a related scientific discipline or Bachelor’s Degree with 15+ years experience in a related field - Experience managing technical staff is desirable - Advanced training in the area of technical expertise - Previous training and guidance of laboratory personnel - Expertise in analytical techniques including HPLC, GC, LC/MS, and other spectroscopic techniques. - Experience in method development and validation of peptides and biomolecules is desirable. - Knowledge of analytical science as it relates to pharmaceutical product development is required - Demonstrated leadership skills - Appropriate level of understanding of applicable regulations Please email your resume to - dan.wienczkowski@rightthinginc.com"

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