Development Scientist I, Biological Analytical Development & QC
AstraZeneca

Job Info

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This is what you will do:

The Development Scientist I position is a technical position responsible for development and optimization of release and stability methods using lab automation platforms for sample prepration and assay automation to support clinical and commercial biotherapeutics. This position will also support other analytical method development related to characterization and investigation efforts, as well as conduct testing for Alexion's biotherapeutic 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 expected 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 cutting-edge technologies to improve throughput 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 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 develoment teams.
• Evaluate new instruments, methods, techniques and technology platforms to enhance analytical operations.

You will need to have:

• Ph.D degree or Masters degree with experience, in Chemistry, Biology, Biochemistry, Chemical Engineering or related discipline. 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 an 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 skills and a strong ability to communicate effectively
• 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.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

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