PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud‑based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.The Analytical Sciences department is seeking a skilled Analytical Biochemist and/or Biologist at the Research Associate level to join a team focused on supporting gene therapy and enzyme replacement therapy. The successful candidate will be a self‑motivated, independent, and critical thinker who has experience working in a multi‑disciplinary and fast‑paced environment, and solid communication skills. The candidate will execute a wide variety of analytical methods and assays for the characterization of therapeutic candidates in development with a particular focus on testing to support clinical and commercial process development teams.ResponsibilitiesExecute product testing to support Drug Substance and Drug Product process development teams.Perform non‑routine testing of in‑process samples and final product samples of key projects for the TDS processing team.Conduct analytical tests using techniques such as HPLC, UPLC, CE, FTIR, and plate‑based methods.Document all test results accurately and in compliance with Good Laboratory Practices (GLP) and company SOPs.Collaborate with cross‑functional teams including Drug Substance Technologies, Drug Product Device Technologies, Manufacturing, and Quality.Provide concise and quantitative analysis of data and interpretation of experimental results.Provide effective oral presentations at departmental meetings.Report progress to the manager on a weekly basis for each program.Write up experimental plans and results, share with collaborators and supervisor, and present data proactively and regularly in group meetings.Catalogue data/reports electronically in an accessible manner for inspections.Required SkillsStrong understanding of GMP, GLP, and regulatory standards.Familiar with protein chemistry/function and bioassays.Experienced in cell culture techniques and protein expression/activity readout methods.Excellent communication, collaboration, and writing skills.Proven data analysis, interpretation, and scientific communication skills.Proven flexibility and execution skills to deliver in a fast‑paced, multi‑tasking environment.Desired SkillsExperience in method troubleshooting, qualification, and transfer.Knowledge of biopharmaceutical development is a plus.EducationResearch Associate 1: Bachelors degree in biological sciences and at least 2 years of relevant experience, or 1 year experience with a Masters. Title will be commensurate with experience.Research Associate 2: Bachelors degree in biological sciences and at least 3 years of relevant experience, or 2 years experience with a Masters. Title will be commensurate with experience.EquipmentOperation of standard laboratory equipment for biochemistry and for cellular assays.Will report to the Sr. Manager Analytical Services.
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