Development Scientist III, Analytical Development and Clinical Quality Control
$138,392–$207,590 year
Hybrid · New Haven, Connecticut, United States
Job Summary
Lead development, qualification and optimization of bioassay and process-derived impurity methods to support release, stability testing, and regulatory filing (IND/BLA) for biotherapeutics. Responsible for phase-appropriate qualification of bioassays and impurity methods, authors SOPs and study/protocol reports, drafts IND/BLA sections, and presents technical solutions in cross-functional settings. Requires strong analytical biology expertise (bioassays, impurity methods), familiarity with cGMP/ICH/USP/WHO guidelines, ability to transfer/validate methods, and collaboration across Research, Drug Substance Development, Injectable Drug Product Development, Manufacturing, QA and QC. Travel up to 20% and operating in a lab environment with potential PPE use. Strong communication and organizational skills, plus initiative in problem solving and ability to contribute to regulatory filings and responses to Health Authority queries. This role emphasizes leadership in cross-functional problem-solving, method development/qualification, and strategic technical proposals within a pharmaceutical/biotech setting.
Required Qualifications
- 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
- 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
- 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 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
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