Analytical Development Scientist II

Job description

Serán is seeking a Scientist II who will support the development, optimization, and validation of analytical methods used to characterize small molecule drug products for early and late phase clinical R&D to support client GMP Clinical Release and Stability programs. The work performed in this role will help to shape analytical strategy, collaboration across functions, and deliver high‑quality data that enables the success of early/late phase clinical programs ### Duties and Responsibilities - Perform analytical testing such as UHPLC/HPLC, KF, Water Activity, Dissolution to support small molecules drug product development in GMP environment - Develop and optimize methods for drug products and APIs across early phase and late phase clinical stages - Execute method transfers to QC or partner labs, ensuring robustness and compliance. - Plan, troubleshoot, and independently execute laboratory studies, generating high‑quality data for CMC decision‑making. - Prepare and review technical reports, analytical methods, and protocols, contributing to regulatory‑ready documentation. - Collaborate with cross‑functional teams (QC, QA, Process Development, Project Management) and communicate results to internal and external stakeholders. - Act as a subject matter expert (SME) in analytical development, providing technical leadership and supporting analytical strategy. - Initiate, draft, and perform testing for discrepancy reports; as necessary. - Maintain GMP training certification to be able to perform work in a GMP laboratory - Provide regular updates to management on projects - Identify opportunities for process improvements and propose solutions - Identifies out of trend data. - Responsibilities may increase in scope to align with company initiatives. ### Required Skills & Abilities - Proven analytical method development experience (preferably HPLC) with at least 1-2 years in a cGMP pharmaceutical industry lab - Scientific curiosity and willingness to learn - Demonstrates intermediate expertise with analytical equipment (e.g. disso, KF, GC, LC, XRPD, or mDSC; preferred LC and GC) - Conveys general understanding of USP, ICH, and EP guidance as they pertain to method validation/qualification/transfer and general chapters for relevant instrumentation - Excellent verbal and written communication skills - Excellent organizational skills and attention to detail - Excellent time management skills with a proven ability to meet deadlines - Strong analytical and problem-solving skills. - Ability to function well in a fast-pace work environment - Demonstrated ability to collaborate and work in cross-functional teams - Accepts feedback and constructively manages conflict - Proficient with Empower - Proficient with Microsoft Office Suite or related software ### Education & Experience - Bachelor’s degree in chemistry or related field, with 4 years of hands-on lab experience preferred; or - Master’s degree in chemistry or related field, with 2 years of hands-on lab experience preferred. - Requires 1 year of GMP experience. ### Physical Requirements - Prolonged periods of sitting or standing at a desk and working on a computer. - Prolonged periods of standing or sitting while monitoring laboratory equipment. - Must be able to lift up to 15 pounds at times. - Adheres to consistent and predictable in-person attendance.