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Development Scientist I, Analytical Development and Clinical Quality Control

Location New Haven, Connecticut, United States Job ID R-196992 Date posted 10/04/2024

This is what you will do:

  • The Development Scientist I position is a technical and bench position responsible for development, qualification, and characterization of ligand binding assay (ELISA or other homogeneous methods) and process-derived Residual DNA assay to support process development and GMP release of Alexion’s biotherapeutic products. 

  • This position also supports non-GxP sample testing and regulatory filing (IND and BLA). Participation in method validation and transfer or troubleshooting and investigations of ligand binding assay as well as impurity methods to internal and external laboratories may be required. 

  • In addition, this position will interact regularly with other functional areas, such as Research & Development groups as well as Manufacturing, Quality Assurance and Quality Control groups. The ability to accurately and independently plan and execute procedures and protocols at the bench as well as draft reports and CMC section content for regulatory filings pertaining to test methods is a crucial requirement of this position.

You will be responsible for: 

  • Develop, optimize, and perform at the bench for phase-appropriate development and qualification for ligand binding assay (ELISA or other homogeneous methods) and Residual DNA methods (KingFisher extraction and qPCR) to support process characterization and product release.

  • Author SOPs, study plans, protocols, method development reports and qualification reports. Draft corresponding IND and BLA sections for regulatory filing.

  • Perform routine sample testing at the bench for in-process, drug substance and drug product release and stability samples for ligand binding and impurity assays as needed.

  • Work with various Research and Development teams to support transfer of analytical test methods for pipeline development and clinical support.

  • Explore new innovative technologies and automation to improve throughput and efficiency of impurity methods.

  • Maintain 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.

You will need to have:

  • Ph.D. and 1-3 years of work experience or Master degree with equivalent level of experience, in Biochemistry, Molecular Biology, Immunology, Chemistry, Bioengineering or related discipline.

  • 1-3 years of experience in ligand binding assay (such as ELISA) and residual DNA (DNA extraction and PCR)

  • Experience with method development, optimization, qualification, validation, transfer, and investigation for biotherapeutics

  • Strong scientific skills in biochemistry and molecular biology with good understanding of biological pathways and biotherapeutics’ mechanism of actions are essential. Assay automation is highly preferred.

  • Familiarity with cGMP, ICH, USP and WHO guidelines on regulatory requirements for method qualification and validation is highly preferred. GLP and GMP working experiences are a plus.

  • The ability to independently contribute and oversee the generation of procedures, protocol and reports pertaining to test methods.

  • Excellent interpersonal skills and a strong ability to communicate effectively.

  • High level of proficiency in MS Office software including Word, Excel, Outlook, PowerPoint as well as laboratory software (e.g. Softmax and/or PCR) is necessary

  • The duties of this role are conducted in the 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.

  • Ability to travel up to 10%, if needed.

We would prefer for you to have:

  • Familiarization with homogeneous binding assay (Lumit, TR-FRET, AlphaLISA, magnetic etc.) and KingFisher DNA extraction is preferred. 

  • Work experience in the pharmaceutical or biotech industry is highly preferred.

In-person statement for 4 days in the office:

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. 

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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