Senior Scientist I, Analytical Development

Senior Scientist I, Analytical Development W2 Contract-to-Hire Salary Range: $124,800 - $145,600 per year (Base pay: $60.00/hr - $70.00/hr) Location: Redwood City, CA - Onsite Role Requirements and Qualifications: Must be onsite 3‑4 days a week. PhD with a minimum of 5 years of relevant experience, OR Master’s with a minimum of 8 years of experience. 5+ years in small‑molecule analytical development and method development. Experience in CMC. Proficiency in analytical techniques: HPLC/UPLC, LC‑MS, XRPD, dissolution testing, DSC, DVS, compendial methods (USP/EP). Understanding of ICH guidelines (Q2, Q6A, Q3A, B, C, D, M7) and FDA/EMA regulatory expectations. Preferred Qualifications: Strong data interpretation and problem‑solving skills. Excellent written and verbal communication; ability to translate complex scientific concepts into clear documentation. Duties and Responsibilities: Support analytical development and testing activities at contract organizations (CMOs/CROs): method development, qualification/validation, release/stability testing. Serve as technical SME for analytical methods, ensuring outsourced activities meet quality standards and project timelines. Review/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 align analytical work with project goals and regulatory expectations. #J-18808-Ljbffr Bayside Solutions