Development Scientist III, Analytical Development and Clinical Quality Control

AstraZeneca • New Haven, CT

11d • $138,392 - $207,590 • Hybrid

About The Position

The Development Scientist III position is a technical role responsible for the development, qualification, and optimization of bioassays (biological activity/potency assay of drug candidates) and process-derived impurity methods (HCP, residual Protein A, residual DNA). This role supports the release and stability testing of biotherapeutic products, as well as formulation and process development. It also contributes to regulatory filings (IND and BLA) and responses to Health Authorities’ queries. Responsibilities may include participating in methods transfer, validation, troubleshooting, and investigations of bioassay and impurity methods for internal and external laboratories. The position requires regular interaction with other functional areas, including Research, Biologic Drug Substance Development, Injectable Drug Product Development, Manufacturing, Quality Assurance, and Quality Control groups.

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 a pharmaceutical or biotechnology setting.
• High preference for experience 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.
• Familiarity 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 a good understanding of biological pathways and biotherapeutics’ mechanism of actions.
• Ability to take initiative in problem solving and consistently bring an 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.
• Proficiency with JMP and SoftMax Pro.
• The 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.
• Ability to lift/carry 15/30 pounds unassisted/assisted.
• Ability to work comfortably in a controlled environment with and around biological, infectious, and hazardous materials.
• Ability to gown/de-gown PPE.
• Ability to use a computer.
• Ability to engage in communications via phone, video, and electronic messaging.
• Ability to engage in problem solving and non-linear thought, analysis, and dialogue.
• Ability to collaborate with others.
• Ability to 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.
• 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.
• Phase-appropriate qualification for process-derived impurity methods and impurity work strategy to support process development, product release specification, and regulatory filing.
• Making scientific/technical proposals of a strategic nature based on corporate or project objectives and understanding the impact of decisions on corporate/project objectives.
• Authoring SOPs, study plans, protocols, and method development/qualification reports.
• Drafting corresponding IND and BLA sections for regulatory filing and authoring responses to health authority queries and requests.
• Leading cross-functional scientific/technical problem-solving efforts.
• Carrying out authentic, persuasive scientific/technical presentations of a strategic nature in a cross-functional environment.
• Assisting with prioritizing technical work efficiently to meet project timelines.
• Demonstrating a strong ability to multi-task and achieve milestone deliverables across multiple projects.
• Exploring new innovative technologies and automation to improve the throughput and efficiency of bioassay and impurity methods.
• Establishing continuous improvement systems based on lessons learned and incorporating improvements into business practices.
• Positively contributing to improving the working environment and engaging in ongoing 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