The purpose of the Research Associate is to carry out assigned laboratory duties which may include sampling, testing, and evaluating analytical data on samples such as raw materials, in-process, and final drug products. In addition, will also participate in the development and validation of analytical methods.
Perform methods development and validation for in-process and final product analyses. Carry out product testing and stability studies, as needed. Conduct laboratory tests in compliance with established internal Standard Test Methods (STMs), compendial and vendor/partner supplied methods. Maintain organized records of tests performed and results obtained by following company policies. Perform troubleshooting and preventative maintenance of laboratory equipment. Participate in writing documents for GMP compliance and regulatory submissions such as standard test methods, validation reports, and SOPs. Provide technical assistance and training to other laboratory personnel. Understand and comply with all company policies, safety procedures, and SOPS, including cGMPs and GLPs. Assist in the preparation analytical data for internal and external meetings and presentations. Conduct laboratory tests in compliance with established Standard Test Methods (STMs) and within regulatory and laboratory requirements. Assist in performing laboratory investigations. Contribute to written investigation reports as required. Maintain a level of technical knowledge and understanding in the assigned areas of responsibility that are consistent with the current scientific requirements of the company. Participate in the transfer of methods to/from the Quality Control department. Represent functional area in Project Teams, as required.
BS/MS degree in the Life Sciences. 2-5 years combined academic and pharmaceutical industry experience. Good understanding of the chemical and physical principles upon which formulation, process development and analytical methodology is based. Familiarity with cGMPs. Competent in using typical laboratory and processing equipment (e.g. HPLC, GC, pH meter, centrifuge, Dissolution, etc.). Ability to utilize scientific information resources within the assigned area of responsibility. Good observation, problem-solving, and troubleshooting skills. Solid understanding of the design of experimental protocols. Good documentation skills (notebook, reports) with attention to detail and legible handwriting. Good organizational skills (daily tasks, documentation, archived information). Good interpersonal skills (e.g. working with members of other teams to achieve shared goals). Good verbal and written English communication skills; able to participate in scientific discussions and written interactions. Proficient in the use of computers and widely used workplace applications (Microsoft Office, Outlook, Excel, etc.). Ability to be flexible in adapting work plan to current corporate goals. Good time management skills (multi-tasking and task prioritization).