Senior Scientist I, Analytical Development

Senior Scientist I, Analytical Development Location: Redwood City, CA – Onsite Role Salary Range: $124,800 - $145,600 per year Duties and Responsibilities Support analytical development and testing activities at contract organizations, including method development, method qualification/validation, and release/stability testing. Serve as a technical subject matter expert (SME) for analytical methods, ensuring that outsourced activities meet quality standards and project timelines. Review and interpret data from method validations, release testing, and characterization studies for drug substance (DS) and drug product (DP). Prepare, review, and/or approve protocols, reports, and regulatory submission documents (IND, NDA/MAA, IMPD). Collaborate cross-functionally with Quality, Regulatory, and external partners to ensure analytical alignment with project goals and regulatory expectations. Requirements and Qualifications PhD in Chemistry, Pharmaceutical Sciences, or a related field with a minimum of 5 years of relevant industry experience; or MS with 8+ years of experience in analytical development. Proficiency in analytical techniques such as HPLC/UPLC, LC-MS, XRPD, dissolution testing, DSC, DVS, and compendial methods (e.g., USP/EP). Understanding of ICH guidelines (e.g., Q2, Q6A, Q3A, B, C, D, M7), FDA/EMA regulatory expectations, and phase-appropriate analytical development. Preferred Qualifications Strong data interpretation and problem-solving skills. Excellent written and verbal communication skills, with the ability to translate complex scientific concepts into clear documentation. Desired Skills and Experience Analytical development, method qualification, method validation, release testing, stability testing, CMO management, CRO management, technical subject matter expertise, data interpretation, protocol preparation, regulatory submission documents, IND, NDA, MAA, IMPD, Quality collaboration, Regulatory collaboration. HPLC, UPLC, LC-MS, XRPD, dissolution testing, DSC, DVS, compendial methods, USP, EP, ICH guidelines, Q2, Q6A, Q3A, Q3B, Q3C, Q3D, M7, FDA regulations, EMA regulations, phase-appropriate analytical development, problem-solving, scientific documentation, technical writing, cross-functional collaboration, outsourced activity management, analytical method expertise. Note: Bayside Solutions, Inc. is not able to sponsor any candidates at this time and requires W2 employment. #J-18808-Ljbffr Bayside Solutions