Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.

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:

• 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:

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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Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: www.alexion.com.

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 has taken critical steps to protect colleagues, loved ones, and patients from COVID-19 and its variants. All US-based employees must comply with Alexion's COVID-19 vaccination mandate. Alexion provides exceptions based on applicable state law as well as reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding a legally required exemption or accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.

As a leading employer in our industry, Alexion offers a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, and much more.

AstraZeneca completed its acquisition of Alexion, marking the creation of Alexion, AstraZeneca Rare Disease. If you're interested in career opportunities with AstraZeneca, click here.