Analytical Development Scientist II

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.