Job Description
This is what you will do:
The Associate Scientist III will join Injectable Drug Product Development group to support the formulation and drug product process development of Alexion’s biotherapeutic candidates. This individual will lead and support execution of stability studies, develop fit for purpose analytical methods, perform analytical testing, and draft reports for the executed studies. This individual will work independently in a dynamic team environment and routinely collaborate with other members of Injectable Drug Product Development as well as other groups in Product Development and Clinical Supply. A general understanding of protein chemistry and machine learning based image analysis is preferred.
You will be responsible for:
• Execution of stability studies for injectable drug products.
• Actively participate in department and team meetings including assuming ownership and delivering on assign action items
• Supporting analytical method development and optimization
• Prioritizing multiple assigned tasks and projects independently and as part of the team
• Author SOPs, study protocols and technical reports with minimal supervision
• Assisting in preparation of external regulatory submissions (IND, BLA etc.) for the Alexion product candidates
• Prepare presentations for meetings with internal and external stakeholders with minimal supervision
You will need to have:
• Bachelor’s Degree in Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or relevant Engineering/Life Sciences field with 2+ years of relevant experience or Master’s degree with 1+ years of relevant work experience
• Self-driven initiative to find resolution for technical challenges
• Excellent interpersonal, collaborative and communication skills
• Extensive experience on developing phase appropriate analytical methods.
• Working experience on various injectable dosage forms, especially in prefilled syringes/cartridges.
• Comprehensive understanding of chemistry and stability, and degradation mechanism of proteins.
• Firsthand experience with liquid chromatography methods (e.g. SEC, IEX, HIC) and subvisible particulate methods (e.g. LO, MFI).
• Strong knowledge of analytical software (e.g. Empower, JMP).
• Ability to interpret raw data, organize results and communicate findings to project team and management
• The duties of this role are 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/de gown 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:
• Scientific and practical knowledge of protein biochemistry and/or drug product process development.
• Previous experience in subvisible particulate analysis with compendial and orthogonal techniques.
• Experience in machine learning based image analysis (e.g. subvisible particulate image from MFI), including the algorithm optimization, model training, validation, and ability to coding with commonly used programming language/platform (e.g. Python, TensorFlow) is a plus.
• High level proficiency in MS Office software including Word, Excel, Outlook, Visio, and PowerPoint.
Date Posted
27-Sep-2024
Closing Date
03-Oct-2024Alexion 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
ac************@Al*****.com
. Alexion participates in E-Verify.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
