Senior Research Associate
 Advanced Clinical | |
 United States, California, Oceanside | |
 Jan 09, 2025 | |
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OVERVIEW
We are currently searching for a skilled professional to join a well-known client's team as a Senior Research Associate in Oceanside, CA. The Senior Research Associate role will develop and characterize formulations and processes for all biologic drug products in pivotal and commercial stages. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity. RESPONSIBILITIES * Perform experiments pertaining to: o Protein formulation/stability of various dosage forms (liquid/lyophilized) and configurations (vial/syringe), employing a variety of biochemical and biophysical analytical techniques, such as HPLC, capillary electrophoresis, and/or spectroscopy methods o Scale-down/-up of biologics drug product processes o In-use stability and administration * Author protocols, technical summary reports/memos and tech transfer documentation defining the manufacturing process and parameters * Review Master Batch Records for accuracy and trend process data supporting process development or fill/finish manufacturing operations * Execute studies in support of drug product technology transfers to clinical and commercial manufacturing sites * Be an effective communicator of ideas, project goals and results at departments/meetings in both written and presentation format. * Be self-motivated, organized, thrive in team settings and enjoy scientific investigation and thinking, as well as be familiar with the relevant technical literature. EXPERIENCE & EDUCATION * A minimum of 5+ years of experience with BS degree or 3+ years of experience with MS degree in Pharmaceutical Sciences, Biology, Biochemistry, Biochemical Engineering or a related scientific discipline. To be a best-fit your strengths must include: * Experience working with Biologics molecules (proteins, mAbs); experience working with ADC is a plus * Protein formulation/stability of various dosage forms (liquid/lyophilized) employing a variety of biochemical and biophysical analytical techniques, such as HPLC, capillary electrophoresis, and/or spectroscopy methods, analytical data analysis * Experience with some scale-down/-up of biologics drug product process development activities; buffer preparations, testing using compendial methods (osmo, protein conc., pH, etc.) and UF/DF is a plus * Relevant industry experience that demonstrates expertise in drug product development as well as sustained excellence in performance and accomplishments that align to company goals. * Excellent communication (both verbal and technical) and interpersonal skills are required. * Technical proficiency, scientific creativity, collaboration with others and independent thought in suggesting experimental design and research strategy. About Advanced Clinical Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com. Regarding your application Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately. | |