Development Scientist I, Bioanalytical Devel ad QC

This is what you will do:

The Development Scientist I is a technical position responsible for the development and optimization of release and stability methods using lab automation platforms for sample preparation and assay automation to support 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 automation methods for sample preparation and assay automation to evaluate key quality attributes for therapeutic proteins (cell-based, ELISAs, sample dilutions, 96/384 well plate applications, etc.).
• Maintenance and troubleshooting of analytical instrumentation (e.g. Integra Viaflo, Perkin Elmer Janus Liquid Handler Workstation, Waters Andrew+).
• Support application of new innovative technologies to improve efficiency and enhance capability of cGMP testing.
• Author SOPs, study plans, protocols, and method development reports. Draft reports for regulatory filing.
• Work with various Research and Development teams to support transfer of analytical test methods for development and clinical support.
• Work 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).
• Maintain knowledge of current scientific principles and theories. Train other lab personnel as assigned in areas of expertise and participate in cross-functional process develoment teams.
• Evaluate new instruments, methods, techniques and technology platforms to enhance analytical operations.

You will need to have:

• Ph.D degree or Master's degree with experience, in Chemistry, Biology, Biochemistry, Chemical Engineering or related field. A Bachelor's degree with an appropriate level of experience may also be considered.
• 3+ years hands on experience with various lab automation technologies.
• Experience in developing, optimizing, and validating new assays.
• Scientific and practical knowledge of protein characterization for protein therapeutics including monoclonal antibodies and glycoproteins.
• Ability to take initiative in problem solving and consistently bring independent, scientific approach to method development.
• Ability to travel up to 20% 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:

• Experience with qualification and validation of automation platforms for protein therapeutics.
• Excellent interpersonal and communication skills
• Knowledge of cGMP and quality guidelines (e.g. ICH Q2).
• Strong experience in preparing regulatory submissions and responding to regulatory inquires.
• High level of proficiency in MS Office software including: Word, Excel, Outlook, and PowerPoint.
• The ability to independently author procedures, protocol and reports pertaining to test methods.

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

29-Feb-2024

Closing Date

30-May-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 [email protected]. 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.