Job Description EDUCATION / EXPERIENCE REQUIREMENTS Bachelor's degree in science with 2+ years of proven Pharmaceutical Analytical Laboratory experience A Master's degree or higher in Science, with 1+ years of proven Pharmaceutical Analytical Laboratory experience Must have a minimum of 1 year experience in the QC or R&D in pharmaceutical industryREQUIRED SKILLS Must have Hands-on experience with Waters & Agilent HPLC / UPLC and dissolution apparatus (USP Type 1 and 2). Hands-on experience in using Waters Empower3 software. Understands fundamental analytical chemistry and chromatography. Able to quickly learn specialized-stability studies software. Able to troubleshoot testing and/or analytical method related issues. Understands and follows GMP / SOP requirements. Familiar with analytical laboratory documentation practices. Expertise in MS Office, such as Word, Excel, and PowerPoint. Good communication and interpersonal skills. This individual must be highly motivated, have a positive can-do attitude and the ability to work in a fast-paced environment as a collaborative team player. Practical knowledge and experience with application of analytical method development and method validation activities.PREFERRED SKILLS Goes the extra mile to get things done at high quality. Ownership of the work.POSITION SUMMARYThe Associate Scientist Analytical Development performs extensive laboratory work to support specialized software-based stability studies. The Associate Scientist, with minimum supervision, ensures all tests are completed on time, results are accurate, and all activities are documented. The Associate Scientist effectively presents the results in the AD meetings. Research & Development (R&D) Center in Morristown, NJ is focused on development of over-the-counter drug products in categories of Allergy, Cough & Cold, Pain & Cardio.RESPONSIBILITIES Performs extensive laboratory work to support the specialized software-based stability studies for the determination of shelf-life of the drug product. Write SOPs/guidelines/OI/reports related to the stability studies, specialized stability software and any other as needed. Must be able to perform the Assay method, Impurities method and dissolution method for the drug products. Accurately and timely documents the experiments and results into the notebooks, ELN and LIMS (if required). With minimum supervision, manages projects to ensure all tests are completed on time, results are accurate, and all activities are documented. Effectively communicates to all stakeholders the analytical activities and findings. Follows SOPs/OIs and analytical laboratory practices to ensure the work quality and compliance. Interacts with analysts on the data review to recommend appropriate corrections / modifications / improvements needed to build consistency with respect to documentation practice guideline. Perform other duties as assigned.***Drug screen & criminal background check will be required
- **Only those lawfully authorized to work in the designated country associated with the position will be considered.**
- **Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client's business needs and requirements.**
Benefits: For information and details on employment benefits offered with this position, please visit here . Should you have any questions/concerns, please contact our HR Department via our secure website . California Pay Equity: For information and details on pay equity laws in California, please visit the State of California Department of Industrial Relations' website here . Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender (expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law. Positions located in San Francisco and Los Angeles, California will be administered in accordance with their respective Fair Chance Ordinances. If you need assistance in completing this application, or during any phase of the application, interview, hiring, or employment process, whether due to a disability or otherwise, please contact our HR Department . Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify). (Posting required by OCGA 13/10-91.).