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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:

The Development Scientist III position is a technical and managerial position responsible for development, qualification, and characterization of ligand binding methods to support process development and GMP release of Alexion’s biotherapeutic products. This position will also support non-GxP sample testing, regulatory filing (IND and BLA) and agencies’ responses. Participation in method validation and transfer or troubleshooting and investigations of ligand binding methods to internal and external laboratories may be required. In addition, this position is expected to interact regularly with other functional areas, such as Research & Development groups as well as Manufacturing, Quality Assurance and Quality Control groups.

You will be responsible for:

• Lead ligand binding analytical group in the development, optimization and phase-appropriate qualification of plate-based ELISA and solution-based TR-FRET methods to support process characterization and product release.

• Lead reagent conjugations, characterization, and maintenance of critical reagents through products’ full life cycles.

• Explore new cutting-edge technologies and automation to improve throughput and efficiency of ligand binding methods.

• Hire qualified bioassay scientists and guide them in their daily executions, analytical instrumentation, software, documentation, safety, and compliance. Mentor direct reports for their career development, technical excellence and project management skills.

• Author SOPs, study plans, protocols, method development reports and qualification reports. Draft corresponding IND and BLA sections for regulatory filing.

• Work with various Research and Development teams to support transfer of analytical test methods for pipeline development and clinical support.

• Work with Analytical Technical Transfer Services (ATTS) to develop and execute validation protocols, provide support during and post method transfer (e.g. on-site training and troubleshooting as needed).

• Maintain knowledge of current scientific principles and theories. Train other lab personnel as assigned in areas of expertise and participate in cross-functional process development teams.

  You will need to have:

• 8+ years of analytical method development and qualification experience in pharmaceutical or biotechnology setting, with high preference in ligand binding analytical, such as plate-based ELISA, homogenous TR-FRET, advanced alternative technologies (e.g., GyroLab, KingFisher, Immune-PCR).

• Experience with method development, optimization, qualification, validation, transfer and investigation for biotherapeutics.

• Familiar with cGMP, ICH, USP and WHO guidelines on regulatory requirements for method qualification and validation.

• Technical lead and/or people managing skills highly preferred.

• Experience in preparing regulatory submissions and responding to regulatory inquires is a plus

• Experience in cell-based assay, automation, immune-PCR, gene therapy, bispecific antibodies, is a plus

• Strong scientific skills in biochemistry and molecular biology with good understanding of biological pathways and biotherapeutics’ mechanism of actions.

• Ability to take initiative in problem solving and consistently bring independent, scientific approach to method development.

• Excellent interpersonal skills and a strong ability to communicate effectively

• High level of proficiency in MS Office software including Word, Excel, Outlook, Visio, PowerPoint, Softmax

• The ability to independently contribute and oversee the generation of procedures, protocol and reports pertaining to test methods

• Ability to travel up to 10% to support on-site training and troubleshooting

• 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:

• Ph.D. or Master degree with equivalent level of experience, in Biochemistry, Molecular Biology, Immunology, Chemistry, Bioengineering or related discipline.

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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 (https://careers.astrazeneca.com/) .