Job Title: Development Scientist II, Analytical Development and QC
Location: New Haven, Connecticut, United States
Job ID: R-222358
Date posted: 09/04/2025
About the Company:
Alexion, a part of AstraZeneca, is dedicated to developing life-changing therapies for rare and complex diseases. We are at the forefront of innovation, developing biotherapeutic products to enhance patient outcomes. Our mission is driven by science, and our employees are committed to advancing patient care across the globe.
Job Responsibilities:
Method Development and Optimization:
Develop, optimize, and qualify custom (U)HPLC chromatographic methods to evaluate key quality attributes of therapeutic proteins (SEC, RP-HPLC, Ion-Exchange, HIC, etc.)
Supervise the operation, maintenance, and troubleshooting of analytical instruments (e.g., UPLC, HPLC, various detectors such as CD, ELSD, FLS, UV)
Prioritize activities and ensure smooth function of analytical testing operations
Collaboration and Support:
Collaborate with Research and Development teams to support the transfer of analytical test methods for development and clinical support
Lead ADQC analytical support in drug development cycles and drive milestones with cross-functional teams
Seek out and evaluate new instruments, methods, techniques, and technology platforms to improve analytical operations
Documentation and Reporting:
Author SOPs, study plans, protocols, and method development reports for regulatory filings
Provide technical content for regulatory submissions related to analytical sections
Training and Leadership:
Mentor lab personnel and provide training in areas of expertise
Lead troubleshooting efforts and investigations to resolve analytical issues
Innovation and Problem Solving:
Apply innovative technologies to improve cGMP testing efficiency
Lead the generation of procedures, protocols, and reports for test methods
Engage in problem-solving and non-linear thinking to address issues in analytical methods
Required Qualifications:
Education:
PhD or Master’s degree in Chemistry, Biochemistry, or related biological science
Experience:
Experience with (U)HPLC and method development/optimization for protein therapeutics
Strong initiative in problem-solving and applying scientific methods to method development
Knowledge and experience in CMC within the pharmaceutical or biotech industry preferred
Experience in technical content creation for regulatory submissions
Skills:
Ability to lead tasks, troubleshoot, and conduct investigations independently
Excellent communication skills, both verbal and written
Ability to travel up to 20% for training and troubleshooting support
High attention to detail in maintaining accurate lab records
Preferred Qualifications:
Experience:
3+ years of relevant industry experience or equivalent combination of education and experience
Experience with regulatory guidelines (e.g., ICH Q2 and Q14) and cGMP requirements
Other:
Strong interpersonal and mentoring skills
Ability to recognize and address aberrant test/sample conditions
High emotional intelligence and problem-solving capabilities
Compensation and Benefits:
Salary:
Competitive compensation based on experience and qualifications
Benefits:
Comprehensive health benefits including medical, dental, and vision
Paid vacation, holidays, and retirement plans
Opportunity for personal and professional development
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