USA - Quality Control Chemist - IV

Job Responsibilities:

• Support the Project Lead for method transfer and/or validation activities internally and externally for assigned programs
• Author and/or review protocols and reports for method transfer, method validation, method bridging, and other associated technical development reports
• Plan, manage, and track method transfer and/or method validation deliverables
• Collaborate with internal global QC testing sites/labs, external testing labs, project leads, and functional representatives
• Review method transfer and validation assays, perform data verification, conduct non-routine data mining, and execute in-depth data analysis
• Represent Quality Control in intra-departmental initiatives and cross-functional project teams in support of program and company objectives

Skills:

• Expertise in designing and evaluating method validation and method transfer studies, including partial re-validation, co-validation, and cross-validation approaches
• Strong technical writing skills for authoring analytical methods, validation studies, transfer protocols, and reports
• Expert knowledge of scientific principles related to monoclonal antibodies (mAb), ADCs, vaccines, and gene therapy
• Strong analytical mindset with experience in analytical and plate-based methods
• Experience with analytical separation techniques such as SEC, icIEF, and CE-SDS (preferred but not required)
• Excellent project management skills with the ability to manage multiple projects simultaneously
• Strong data interpretation, troubleshooting capabilities, and sound scientific judgment
• Effective time management, attention to detail, and goal-oriented work ethic
• Strong communication skills with the ability to lead teams and influence cross-functional stakeholders
• Solid understanding of regulatory guidance and requirements (ICH, CFR, and general regulatory guidance) related to method transfer, validation, and regulatory submissions such as IND, IMPD, BLA, and NDA

Education/Experience:

• Bachelor’s degree in Life Sciences (Analytical Chemistry, Biology, Biochemistry, Pharmaceutical Science, or related discipline); post-graduate degree preferred
• 8–10 years of relevant experience in pharmaceutical or biological drug product development, analytical chemistry, and/or Quality Control within a regulated biotechnology or pharmaceutical company, with progressive levels of responsibility