Senior Scientist , Analytical Development

Position Summary

Senior Scientist 1, Analytical Development, is responsible for developing, optimizing, and executing analytical methods to support the progression of small molecule drug substance and drug product programs from candidate nomination through regulatory submission and commercial launch. This is a hands‑on, laboratory‑based role requiring strong technical expertise in analytical chemistry. The Senior Scientist 1 independently leads analytical activities for assigned projects, including method development, qualification/validation, transfer, and troubleshooting, with oversight of outsourced work conducted at CROs and CDMOs.

The role collaborates closely with cross‑functional partners across CMC, Technical Operations, Quality, Regulatory Affairs, and external vendors to support development, manufacturing, and regulatory strategies.

• Provide hands‑on expertise in chromatographic method development (e.g., HPLC/UPLC), dissolution testing, and small molecule characterization, ensuring methods are phase‑appropriate and aligned with program and regulatory requirements.
• Act as a subject matter expert and independently lead analytical development activities for assigned projects.
• Develop, optimize, validate, and transfer phase‑appropriate analytical methods to support programs from early development through commercialization using relevant analytical techniques.
• Apply phase‑appropriate analytical strategies to method development, stability studies, impurity profiling, forced degradation studies, comparability assessments, and method lifecycle management.
• Generate high‑quality, scientifically sound data and apply data‑driven judgment to recommend analytical strategies and development approaches.
• Serve as a technical expert for analytical instrumentation and methodologies, with the ability to troubleshoot laboratory, method, and instrumentation issues.
• Maintain accurate and detailed laboratory documentation in accordance with company policies and regulatory guidelines.
• Work closely with lab operations leader to implement laboratory best practices and provide technical guidance and mentorship to junior team members.
• Communicate analytical findings, risks, and recommendations clearly through well‑written technical documents and effective verbal and visual presentations.
• Provide scientific oversight, root‑cause analysis, and technical input for quality events, including OOS/OOT investigations, deviations, and CAPAs.
• Collaborate closely with cross‑functional colleagues in Drug Substance, Drug Product, Pharmaceutical Operations, Quality, and Regulatory Affairs to support development and commercialization activities.
• Support regulatory filings (e.g., INDs, IMPDs, NDAs, briefing packages, and other regulatory documents), as needed.
• Perform other duties as assigned.

• Ph.D. in analytical chemistry or related field with a minimum of 5 years of relevant hands‑on experience in pharmaceutical, biotech laboratory, or CDMOs. (Masters with 13 years of experience or Bachelor’s with 15 years of experience may be considered).
• Strong technical expertise in analytical testing, method development, and phase‑appropriate qualification/validation, characterization, and support of stability programs for small molecule API and DP’s.
• Technical proficiency with techniques that include, but are not limited to, HPLC, UPLC, GC, KF, IC, LC‑MS, UV‑Vis, XRPD, and microbial.
• Experience and demonstrated proficiency in additional areas of pharmaceutical development preferred (e.g., solid state analysis, physical characterization, drug product dissolution, or in‑use stability studies).
• Significant and direct work experience with analytical instruments and techniques such as HPLC/UPLC, and solid‑state characterization tools, including DSC, TGA, DVS, XRPD, microscopy, etc.
• Knowledge of cGMP requirements and regulatory guidance (FDA, ICH).
• Excellent written and oral communication skills, including the drafting and reviewing technical documents and the ability to effectively and accurately present data to peers, management, and external partners.
• Excellent ability to work in a…