Actalent Senior Scientist in Bothell, Washington
Scientist, Method Transfer Lead (MTL), is a QC expert in Development QC group with extensive knowledge and experience in method transfer (MT), method validation (MV) and working with CMO/CTL. This individual contributor will lead MV and MT across different functional groups to ensure compliance with cGMP requirements and regulatory expectations align with the project defined timeline.
• Lead and drive the multiple MV and MT activities internally and externally (CMO or CLT) for assigned programs.
• Define the MV and MT strategy timeline to ensure the programs are on track with deliverables.
• Be responsible for authoring, reviewing and approving protocol, report and associate document for cGMP MT/MV activities, by collaborating with internal and/or external QC tech transfer team and testing labs.
• Review test method, assay results/data other in-depth data analysis to MT and MV activities.
• Coordinate the activities with subject matter experts (SMEs) to design the method bridging, feasibility study, comparability study and author other technical reports to support those activities as necessary.
• Lead and provide technical support for the method troubleshooting and investigation during MV and MT.
• Contribute to working instruction, procedure, deviation, investigation, and other quality events to ensure the compliance.
• Present group in intra-department projects to support programs, and provide inputs follow general practices and regulatory guidelines to support the strategic decision making.
• Represent QC in inter-department project/initiative or cross-functional teams in support of program and company goals. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• Bachelor’s degree in life science (advanced degree in a related field is a plus) in analytical sciences, general chemistry, biology, biochemistry, or other related technical discipline.
• A minimum of 10 years relevant experience (alternatively, master’s degree with 8+ years) in pharmaceutical/biological drug product development, analytical chemistry and/or quality control in a regulated biotechnology, pharmaceutical company. (recommended 12+ years overall relevant experience).
• A minimum of 3-5 years of relevant experiences in method qualification, transfer, and validation are required. Previous working experiences with CMO/CTL is a plus.
• Expert knowledge of scientific principles and technical expertise of mAb and ADC analytical analysis and control strategies, able to design and evaluate the design of study/experiment.
• Excellent analytical mindset and technical skills such as different kinds of UPLC/HPLC, icIEF, CE-SDS etc. Knowledge of cell-based assay and compendial assay is a plus.
• Strong communication skills to lead a team and influence other leaders or cross-functional team members.
• Strong time management skills with attention to detail and desire to achieve team and individual goals.
• Familiar with regulatory guidance and requirements (ICH, CFR, general guidance), experience with regulatory submission such as IND, IMPD, BLA or NDA, etc is a plus, but not required.
• Demonstration of successful leadership in a matrix environment to deliver strategic vision.
• Hands on method transfer and validation lead experience with biologics and ADC.
• Experiences with CMO and CTL for MV and MT.
• Strong project management skills, experience with managing multiple projects at the same time is plus.
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Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.
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