Quality Control Chemist – IV

Job Description

Job Summary:

• Method Transfer Lead (MTL), Scientist, is a QC expert within the QCSV group.
• This individual contributor has good understanding of analytical method transfer and/or validation to ensure that method transfer and/or validation comply with cGMP and regulatory expectations.

Duties and Responsibilities:

• 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.

Education and Experience:

• 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.

Knowledge, Skills and Abilities:

• 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, Client, 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.
• Possess strong data interpretation, method troubleshooting, skills and sounds scientific judgement.
• Good time management skills with attention to detail and desire to achieve team and individual goals.
• Good communication skills to lead a team and influence other leaders or cross-functional team members.
• 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.