Senior Scientist

Senior Scientist – Biologics Stability (Contract)

I'm partnering with a leading biotechnology company seeking an experienced Senior Scientist to lead and oversee biologics drug substance and drug product stability programs supporting clinical development. This individual will serve as a stability subject matter expert, managing stability studies conducted through CMOs and contract laboratories while driving data-driven shelf-life, retest period, and regulatory decisions.

Requirements

• BS, MS, or PhD in Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, or a related scientific discipline

• Approximately 11+ years of industry experience with a BS, 9+ years with an MS, or 5+ years with a PhD

• Extensive experience managing biologics stability programs within a pharmaceutical or biotechnology environment

• Strong knowledge of ICH stability guidelines, including ICH Q1A, Q1E, and Q5C

• Experience supporting drug substance and drug product shelf-life determination, retest period assignment, and stability strategy development

• Demonstrated expertise using JMP statistical software for regression analysis, stability trending, variability assessment, and shelf-life projections

• Experience reviewing and interpreting longitudinal stability data, including identification of OOT, OOS, and emerging stability trends

• Experience overseeing stability studies conducted by CMOs and contract testing laboratories

• Strong understanding of cGMP requirements, Quality Systems, deviations, CAPAs, change controls, and investigations

• Knowledge of analytical methods commonly used to evaluate biologic drug substance and drug product stability

• Experience authoring and reviewing stability protocols, reports, SOPs, technical documents, and regulatory submissions

• Excellent communication, technical writing, and cross-functional collaboration skills

• Ability to work independently and manage multiple priorities in a remote environment

Responsibilities

• Develop and execute stability strategies aligned with clinical development, manufacturing, and regulatory objectives

• Define study designs, storage conditions, testing intervals, analytical test panels, acceptance criteria, and study durations

• Oversee execution of stability studies performed by CMOs and external testing laboratories

• Author, review, and approve stability protocols, reports, technical memoranda, specifications, and controlled documents

• Perform statistical analysis and trending of stability data using JMP

• Evaluate degradation profiles, lot-to-lot variability, long-term stability trends, and product quality risks

• Support establishment and justification of drug substance retest periods and drug product shelf-life assignments

• Lead or support stability-related investigations, deviations, CAPAs, change controls, and Quality System activities

• Assess temperature excursions and determine potential product impact using available stability data

• Collaborate with Quality, Regulatory Affairs, Process Development, Supply Chain, Clinical Supply, and external partners

• Drive continuous improvement initiatives related to stability processes, documentation, and statistical methodologies

• Support regulatory submissions, inspections, and responses related to stability programs

Preferred

• Experience working in an FDA-regulated biotechnology or pharmaceutical environment

• Experience supporting IND, BLA, or global regulatory submissions

• Experience developing stability strategies for late-stage clinical development and commercialization

• Experience evaluating storage and transportation excursions for biologic products

• Strong understanding of biologic degradation pathways and stability-indicating analytical methods

Location: Fully Remote

Duration: Contract

Interviews are starting soon, so if you're interested and would like to be considered, give me a call at (919) 892-9841 as soon as you're available.