Senior Scientist

Overview

Summarize the primary purpose & key accountabilities of the position, including scope of responsibility in 5-7 concise sentences. (It may be helpful to complete this section after you have finished the other sections of the document.

• Support Project Lead for method transfer and/or validation internally and externally for assigned program(s).
• Author or review protocols and reports for method transfer and/or method validation or method bridging, and other technical development reports associated with methods.
• Plan and track method transfer and/or method validation deliverables.
• Collaborate and interact with internal global QC testing sites/labs and external testing sites/labs, project leads and functional reps.
• Review method transfer and/or method validation assays, perform data verification, non-routine data mining, and in-depth data analysis.
• Represent QC in intra-department project/initiative or cross-functional teams in support of program and company goals.

• Indicate the formal education, certification or license(s) required and/or preferred. Include the minimum number of years of relevant experience required for the position (where legally permissible).
• • Bachelor’s degree in life science (Post-graduate degree in a related field is a plus) in analytical chemistry, biology, biochemistry, pharmaceutical science or any related technical discipline
• • 8-10 years relevant experience in pharmaceutical/biological drug product development, analytical chemistry and/or QC in a regulated biotechnology, pharmaceutical company with progressive levels of responsibility are required

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  • Expertise in designing and evaluating method validation and transfer studies including approaches such as partial re-validation, co-validation, and cross-validation.
• Technical writing skills for authoring methods, validation, and transfer studies/protocols/reports.
• Expert knowledge of scientific principles and expertise of mAb, ADC, vaccine, gene therapy, able to design and evaluate the design of study/experiment.
• Have good mindset and technical skills of analytical methods and plate-based methods.
• Candidate with analytical separation method experiences (SEC, icIEF, CE-SDS )are preferred but not required.
• Good project management skills and experience managing multiple projects at the same time is essential
• Understand of regulatory guidance and requirements (ICH, CFR, general guidance) pertaining to method transfer and method validation, regulatory submission such as IND, IMPD, BLA or NDA, etc.