Development Scientist II, Analytical Development and Quality Control
Alexion

This is what you will do:

The Development Scientist II, position is a technical position responsible for development and optimization of release and stability methods including physicochemical methods pertaining to Imaged Capillary Electrophoresis (icIEF) as well as traditional Gel/Capillary Electrophoresis (CE-SDS, CIEF, IEX, CZE and SDS-PAGE) for clinical and commercial bio-therapeutics. This position will also support other analytical method development related to characterization and investigation efforts, as well as conduct testing for Alexion's bio-therapeutic products when required. Participation in method validation and transfer or troubleshooting of methods to internal and external laboratories may be required. In addition, this position is encouraged to interact regularly with scientific staff in other Research & Development groups as well as Manufacturing, Quality Assurance and Quality Control groups.

You will be responsible for:

• Development, optimization and phase-appropriate qualification of custom capillary electrophoresis methods to evaluate key quality attributes for therapeutic proteins (charge heterogeneity, primary structure, PTMs, size variant, etc.)
• Organizing activities of self and others as well as supervise operation, maintenance and troubleshooting of analytical instrumentation (e.g., Perkin Elmer LabChip, Protein Simple iCE and MauriCE)
• Supporting application of new innovative technologies to improve throughput and enhance capability of cGMP testing
• Authoring SOPs, study plans, protocols, and method development reports. Draft reports for regulatory filing
• Working with various Research and Development teams to support transfer of analytical test methods for development and clinical support
• Working with Analytical Technical Transfer Services (ATTS) to develop and implement validation protocols, provide support during and post method transfer (e.g. on-site training and troubleshooting as needed)
• Maintaining 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
• Seeking out and evaluate new instruments, methods, techniques and technology platforms to enhance analytical operations

You will need to have:

• Ph.D. or master's degree with equivalent level of experience, in Chemistry, Biochemistry, Chemical Engineering or related field
• 3+ years of analytical method development experience in protein/peptide analysis by gel/capillary electrophoresis in pharmaceutical or biotechnology company
• Scientific and practical knowledge of protein characterization for protein therapeutics including monoclonal antibodies and glycoproteins
• Experience with assay development, optimization, qualification and validation for protein therapeutics is a significant plus!
• Ability to take initiative in problem solving and consistently bring independent, scientific approach to method development
• Knowledge of cGMP and quality guidelines is desired
• Ability to travel up to 20% to support on-site training and troubleshooting

We would prefer for you to have:

• Experience with assay development, optimization, qualification and validation for protein therapeutics
• Excellent interpersonal skills and a strong ability to collaborate effectively
• Knowledge of cGMP and quality guidelines (e.g., ICH Q2 and ICH Q14)
• Strong experience in preparing regulatory submissions and responding to regulatory inquires
• High level of proficiency in MS Office software including: Word, Excel, Outlook, Visio, and PowerPoint
• Accurately and independently contribute and lead all aspects of the generation of procedures, protocols and reports pertaining to test methods
• The ability to manage and lead projects independently, drive CE method development strategies, improve quality and efficiency of workflows, provide scientific guidance to team members, and train and oversee some day-to-day responsibilities of junior scientists
• Ability to lead and participate in cross-functional development teams representing Analytical Development and Quality Control
• Experience with authoring and reviewing CMC sections for regulatory, technical reports, department specific protocols and reports and generating operating procedures

Expectation of working in the office 4 days a week statement: When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of four days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Date Posted
03-May-2024

Closing Date
27-Jun-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 accommodations@Alexion.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.

This job has expired.