Job Description

Summary The Analytical Chemist III independently performs routine and non-routine analysis on raw materials, drug substances, reference materials and drug products using a variety of instrumental and wet chemistry techniques. The Analytical Chemist III will also intermittently serve as a dedicated project leader and subject matter expert for analytical testing requirements for drug development and regulatory submissions. In addition, the Analytical Chemist III maintains the laboratory and all documentation within cGMP guidelines. Essential Duties and Responsibilities Perform routine and non-routine analysis on raw materials, drug substances, reference material and drug products using a variety of instrumental and wet chemistry techniques. Independently design and execute method development and validation activities for pharmaceutical drug product development on a limited basis. Author protocols and reports as needed. Serve as a dedicated project leader and subject matter expert for analytical testing requirements for drug development and regulatory submissions on a limited basis. Mentor and guide junior chemists on a limited basis. Attend client project meetings related to analytical testing timelines on a moderate basis. Conduct laboratory testing in accordance with methods, protocols, SOPs and cGMP guidelines. Assist in maintaining an organized laboratory. Preparing and reviewing documentation such as laboratory notebooks, validation and analysis reports, SOPs, methods and monographs. Develop systems that are cost effective and increase efficiency. Interface with all departments as necessary. Adhere to set safety standards. Participate as a team member, support the company mission, and vision and contribute to the pursuit of the company's goals. Participate actively in regular meetings. Achieve expected performance measures. Other duties as assigned. Qualifications BS or BA degree in Chemistry or a related physical science with 5+ years of analytical drug development in a pharmaceutical laboratory preferred. Master’s degree in Chemistry or a related physical science with 2 years of analytical drug development in a pharmaceutical laboratory preferred. PhD in Chemistry or a related physical science with at least of 1 experience in analytical drug development in a pharmaceutical laboratory preferred. Experience in HPLC analysis, dissolution, and moisture determination techniques strongly preferred. Excellent oral and written communication skill to communicate with the team, peers, management, and external contacts. Experience with interpreting and implementing cGMPs, ICH, FDA, DEA and OSHA guidelines. Must have the ability to work effectively and independently. Working knowledge of personal computers and Microsoft Office Products, including Word, Project, and Excel. Sharp Packaging Services works across the world to create unique commercial and clinical packaging solutions for the pharmaceutical and biotechnology industry. We are made up of two dynamic international divisions, Sharp Packaging Solutions and Sharp Clinical Services. Together our 1,600-strong team works from state-of-the-art facilities in the United States, United Kingdom, Belgium and the Netherlands. We’ve built an exceptional global reputation for the design, serialisation and production of innovative, cost-effective compliance packaging for even the most complex products. Our extensive range includes blister packs, bottles, pouches and stick packs, but our expertise goes far beyond, enabling us to support your product through every stage of design, development, manufacture and delivery. Our clinical services division is one of the world’s leading providers of innovative clinical supply chain services, with a talented and highly experienced team that can handle every aspect of your supply chain. Our work spans everything from drug development and manufacturing to clinical supplies packaging, labelling, distribution, Qualified Person auditing and comparator sourcing. #J-18808-Ljbffr

Job Tags

Similar Jobs