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 Stability Associate III is responsible for performing assigned tasks to support stability activities for Alexion – AstraZeneca Rare Disease Unit clinical phase biotherapeutic candidates. The Stability Associate III will work in collaboration with members of Clinical Stability, Analytical Sciences, IDPD, Device Development, Quality Assurance and other member of PDCS as required as well as external vendors.

You will be responsible for:

• Generate stability studies in Quality Document system and LIMs and related stability final reports and product update reports, route for review and approval.
• Work with CMOs and external storage vendor to obtain approved CDAs, quotes and stability protocols as well as track pending results.
• Maintain stability pull schedules, sample pulls and coordinate sample submission/test requests to test laboratories.
• You will work with internal stakeholders to obtain completed analytical test results; assure quality documents are scanned and archived according to procedures.
• Generate and maintain stability data tables and JMP tables for multiple products; perform data entry and verification, track data from external vendors and enter in LIMs if required, trend data in support of expiry and provide stability assessments in support of testing/laboratory investigations, shipping or storage deviations.
• Serve on Project Teams as stability SME during project development and provide stability updates in presentations as needed.
• Write and revisie stability protocols, SOPs and Quality Documents as required, route for review and approval.
• Performing all job functions in compliance with cGMPs while maintain accurate and legible records; complete training for job function and Company as required.

You will need to have:

• A successful candidate will typically have B.Sc. +4 years of experience working in a relevant laboratory setting, preferably with stability experience and/or analytical testing with knowledge of GMPs and their application in the environment.
• Have a strong working knowledge of governing documents for stability or ability to come up to speed on regulatory and governing stability guidances.
• Ability to document stability results with a strong attention to detail while following the science; ability to recognize trends outside of expected results.
• Able to organize his/her own work on a routine basis with minimal supervision. When asked, the individual is able to provide updates and tracking on his/her tasks.
• Strong communication skills with ability to communicate verbally and in a written format is required; able to interact with Analytical Sciences Operations groups, Quality Assurance and PDCS members.
• Able to navigate external vendor sites and portals for data extraction and review.
• Able to communicate findings to colleagues within the group through presentations.
• Previous experience with Laboratory Information Systems (LIMS).
• Proficient with various MS Office programs, including Word, Excel, Outlook, and PowerPoint as well as SAS JMP statistical software.
• The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: 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:

• Proficient with various MS Office programs, including Word, Excel, Outlook, PowerPoint
• Knowledge of SmartSheet and SAS JMP or equivalent statistical software.

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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.