Development Scientist III, Analytical Development and Clinical Quality Control

Introduction to role:

The Development Scientist III position is a technical position responsible for development, qualification, and optimization of bioassays (biological activity/potency assay of drug candidates) and process‑derived impurity methods (HCP, residual Protein A, residual DNA), in order to support release and stability testing of biotherapeutic products, as well as formulation and process development. This position also supports regulatory filing (IND and BLA) and responds to Health Authority queries.

Participation in method transfer, validation, troubleshooting, and investigations of bioassay and impurity methods with internal and external laboratories may be required. The role is expected to interact regularly with other functional areas, such as Research, Biologic Drug Substance Development, and Injectable Drug Product Development groups as well as Manufacturing, Quality Assurance, and Quality Control groups.

• Development, optimization, and phase‑appropriate qualification of bioassays to evaluate quantitative biological, biochemical, and cellular activities for therapeutic proteins.
• Responsible for phase‑appropriate qualification of process‑derived impurity methods and impurity work strategy to support process development, product release specifications, and regulatory filing.
• Make scientific/technical proposals of strategic nature based on corporate or project objectives and understand the impact of decisions on corporate/project objectives.
• Author SOPs, study plans, protocols, method development/qualification reports. Draft corresponding IND and BLA sections for regulatory filing and author responses to health authority queries and requests.
• Lead cross‑functional scientific/technical problem‑solving efforts. Carry out authentic, persuasive scientific/technical presentations of strategic nature in a cross‑functional environment.
• Assist with prioritizing technical work efficiently to meet project timelines.
• Strong ability to multi‑task and achieve milestone deliverables across multiple projects.
• Explore new innovative technologies and automation to improve throughput and efficiency of bioassay and impurity methods.
• Establish continuous improvement systems based on lessons learned and incorporate improvements into ways of doing business.
• Positively contribute to improving the working environment and engage in ongoing Alexion cultural improvement efforts.

• Ph.D. or master’s degree in Biochemistry, Molecular and Cellular Biology, Immunology, Chemistry, Bioengineering or related discipline with a minimum of 6+ years of analytical method development and qualification experience in a pharmaceutical or biotechnology setting, with high preference in ELISA binding assay, enzymatic assay, cell‑based assay, and process‑derived impurity methods.
• Experience with method development, optimization, qualification, validation, transfer, and investigation for biotherapeutics.
• Familiar with cGMP, ICH, USP and WHO guidelines on regulatory requirements for method qualification and validation.
• Strong scientific skills in biochemistry, molecular and cellular biology with good understanding of biological pathways and biotherapeutics’ mechanisms of action.
• Ability to take initiative in problem solving and consistently bring independent, scientific approach to method development.
• Excellent interpersonal skills and a strong ability to communicate effectively.
• High level of proficiency in MS Office software including Word, Excel, Outlook, Visio, PowerPoint, JMP and Soft Max Pro.
• Ability to independently contribute and oversee the generation of procedures, protocols and reports pertaining to test methods.
• Ability to travel up to 20% to support on‑site training and troubleshooting.
• Lab‑environment work requires ability to lift/carry 15/30 pounds unassisted/assisted; work comfortably in a controlled environment with biological, infectious, and hazardous materials; gown/de‑gown PPE; use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non‑linear thought; collaborate with others; maintain general availability during…