Development Scientist III, Analytical Development and Clinical Quality Control

AstraZeneca • New Haven, CT

9d • Hybrid

About The Position

The Development Scientist III position is a technical role focused on the development, qualification, and optimization of bioassays and process-derived impurity methods. These methods are crucial for supporting the release and stability testing of biotherapeutic products, as well as formulation and process development. The role also involves supporting regulatory filings (IND and BLA) and responding to health authority inquiries. Responsibilities may include participating in method transfers, validation, troubleshooting, and investigations for bioassay and impurity methods, both internally and externally. The position requires regular interaction with various functional areas, including Research, Biologic Drug Substance Development, Injectable Drug Product Development, Manufacturing, Quality Assurance, and Quality Control.

Requirements

• Ph.D. or master’s degree in Biochemistry, Molecular and Cellular Biology, Immunology, Chemistry, Bioengineering or related discipline
• Minimum of 6+ years of analytical method development and qualification experience in pharmaceutical or biotechnology setting
• 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 SoftMax 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.
• 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 communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours

Nice To Haves

• Experience in microbiology assays (e.g. bioburden, endotoxin, and sterility)
• Technical lead and/or people managing skills highly preferred.
• Has knowledge of other technical areas within ADQC/PDCS organization (Other analytical methods such as LC, CE and compendial methods within ADQC; process development and formulation development within PDCS)

Responsibilities

• 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.

Benefits

• short-term incentive bonus opportunity
• equity-based long-term incentive program (salaried roles)
• retirement contribution (hourly roles)
• commission payment eligibility (sales roles)
• qualified retirement program [401(k) plan]
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree