We are seeking a Senior Scientist/Scientist, Analytical Sciences who will carry out the responsibilities of the Analytical Sciences function in a manner which complies with departmental and corporate SOPs, GLPs and cGMPs. He/she will be responsible for analytical activities for an assigned project (projects) to support pre-clinical lead candidate through clinical development registration filings and up to commercialization. This may include participation in departmental planning activities and providing leadership for an assigned project or functional area.
• Coordinate, design and perform laboratory studies with minimal guidance. May plan and coordinate laboratory activities of other staff members. Laboratory studies include the analytical testing of development compounds and formulations; dosing analysis studies to support GLP toxicology and preclinical PK studies; preformulation and stability studies; reference standard characterization; methods development and validation for raw materials, intermediates, drug substances and drug products.
• Perform analytical testing with high proficiency utilizing HPLC, LC/MS, GC, dissolution, UV and FTIR, and other analytical techniques; demonstrate the ability to operate, maintain and trouble-shoot equipment.
• Develop and validate test methods for drug substances, intermediates and drug products.
• Summarize experimental findings, perform data calculations, interpret and document study results, assemble analytical data packages.
• Provide training, guidance and leadership to new and less experienced staff.
• Supervise and direct other employees as appropriate.
• Prepare development reports and assist in the preparation of regulatory submissions.
• Present work at departmental and interdepartmental meetings as appropriate.
• Maintain up-to-date knowledge of applicable industry and regulatory guidelines and requirements and disseminate this information to colleagues.
• Coordinate outsourcing activities as appropriate.
• Draft departmental SOPs, test methods, and other documents; provide input for their continual improvements.
• May serve as liaison with other departments, and outside vendors on projects.
• Identify equipment and technology needs, recommend and purchase equipment.
• Follow departmental and corporate procedures (SOPs).
• Follow current GLP and GMP regulations.
• Maintain research records and lab notebooks in a concise, legible and complete manner.
• Identify systems and areas in need of improvement and coordinate subsequent corrective activities.
• Carry out job responsibilities and assignments safely and maintain a clean and safe work area.