Senior Scientist , Analytical Development

Overview

Senior Scientist I, Analytical Development

Location:

Redwood City, CA (Onsite Role). W2 Contract-to-Hire. Base pay range: $60.00/hr - $70.00/hr salary Range: $124,800 - $145,600 per year.

• Support analytical development and testing activities conducted at contract organizations (CMOs/CROs), including method development, method qualification/validation, and release/stability testing.
• Serve as a technical subject matter expert (SME) for analytical methods, ensuring 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.

• 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.

• Strong data interpretation and problem-solving skills.
• Excellent written and verbal communication skills, with the ability to translate complex scientific concepts into clear documentation.

analytical development, method development, method qualification, method validation, release testing, stability testing, CMO management, CRO management, technical subject matter expertise, data interpretation, method validations, characterization studies, drug substance analysis, drug product analysis, 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, Chemistry, Pharmaceutical Sciences

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• Contract

• Mid-Senior level