Job Description

This is what you will do:

This position will play a key role in Alexion\xe2\x80\x99s 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:

• 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
• 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
• Author analytical method transfer/validation related protocols and reports for late stage clinical and commercial programs.
• Provide subject matter expertise for regulatory interactions including fillings and inspections
• Contribute to analytical method development/optimization, validation, and transfer in the laboratory

You will need to have:

• 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
• 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 of testing strategy for late-stage program in preparation for BLA filing
• Excellent written skill for drafting all the GMP related documents.
• 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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Date Posted 21-Jul-2023

Closing Date 29-Dec-2023

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact . Alexion participates in E-Verify.

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