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 bioassay (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, and also formulation and process development. This position also supports regulatory filing (IND and BLA) and responses to Health Authorities’ queries.

Participation in methods transfer, validation, troubleshooting and investigations of bioassay and impurity methods to internal and external laboratories may be required. In addition, this position 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 for process-derived impurity methods and impurity work strategy to support process development, product release specification, and regulatory filing.

• Makes scientific/technical proposals of strategic nature based on corporate or project objectives and understands the impact of their decisions on corporate/project objectives.

• Authors SOPs, study plans, protocols, method development/qualification reports. Drafts corresponding IND and BLA sections for regulatory filing and authors responses to health authority queries and requests.

• Leads cross-functional scientific/technical problem-solving efforts. Carries out authentic, persuasive scientific/technical presentations of strategic nature in cross-functional environment.

• Assists with prioritizing technical work efficiently to meet project timelines.

• Strong ability to multi-task and achieve milestone deliverables across multiple projects.

• Explores 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 contributes to improving the working environment and engaged in on-going 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 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’ mechanism of actions.

• 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.

• The ability to independently contribute and oversee the generation of procedures, protocol and reports pertaining to test methods.

• Ability to travel up to 20% to support on-site training and troubleshooting.

• The duties of this role are generally conducted in a lab environment. As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15/30 pounds unassisted/assisted; work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown/de-gown PPE; use a computer; engage in…