Development Scientist Ii, Analytical Development And Clinical Qc

This is what you will do:

This position will play a key role in Alexion’s analytical technology transfer service team, which requires analytical experience and proven success in management of development projects. The scientist will need to handle multiple projects in parallel and work closely with other PDCS teams, QA and QC laboratories as a lead to design the strategy of method transfer/validation and overall testing strategy. The scientist will also involve business and technical leadership of the project and leading the analytical team from pre-clinical through product launch. Moreover, this position will provide support for regulatory filing in analytical area.

You will be responsible for:

• Author analytical method transfer/validation related protocols and reports for late stage clinical and commercial programs.
• Participate in troubleshooting and OOS/OOT investigations during method validation and transfer. And provide continuously technical support post method transfer to QC lab.
• Review analytical testing procedures, method performance matrix and testing results across global testing network, provide key inputs to gap analysis reports, gap remediation recommendation and perform method optimization post validation/transfer if necessary
• Contribute to analytical method development/optimization, validation, and transfer in the laboratory
• Interact with cross functional teams, Lead/support method transfer/validation activities for all the release/stability/in-process assays and ensure such activities are completed in timely fashion and Right the First Time
• Ensure communications occur with stakeholders and partners for all the analytical topics
• Provide subject matter expertise for regulatory interactions including fillings and inspections

You will need to have:

• Excellent written skill for drafting all the GMP related documents.
• Strong hands-on experience in the development, validation and transfer of analytical methods for biological products, especially in cGMP environment as listed in ICH Q2, is a significant plus
• Ability to work independently to develop and design experiments, critically evaluate data, and then iterate as part of the scientific method
• Experience in analysis of various Biologic modalities (e.g., mAb, antibody-drug conjugate, fusion protein)
• Extensive experience in separations science (e.g., SEC, RP, IEX). Experience in Molecular biology (PCR, DNA extraction) and immunoassay (ELISA) techniques.
• Background in Analytical Methodologies and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and statistics
• Experience of testing strategy for late-stage program in preparation for BLA filing
• Excellent collaboration skills and experience working in cross functional teams and ability to deliver complex objectives under aggressive timelines in a rapidly changing environment

• 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/degown 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.

We would prefer for you to have:

• Advanced (M.S. or Ph.D.) degree in Biochemistry, Chemistry or related discipline with 2-5 years (Ph.D.) or 10+ (M.S.) hands on biological analytical development experience in pharmaceutical industry

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