Development Scientist I, Analytical Development and Quality Control
AstraZeneca

Job Info

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This is what you will do:

This position is required to perform Bioassay method development and optimization for clinical and commercial biotherapeutics in order to measure biological activity or potency of drug candidates. This position will also support other analytical method development along with characterization and investigation efforts, as well as conduct testing for Alexion's biotherapeutic products when required. Participation in method validation and transfer 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. The ability to accurately and independently generate procedures, protocols, reports, and CMC section content for regulatory filings pertaining to test methods is a crucial requirement of this position.

You will be responsible for:

Development, optimization and phase-appropriate qualification of custom bioassays to evaluate appropriate quantitative molecular, biochemical and cellular assays for evaluation of therapeutic proteins. Author SOPs, study plans, protocols, and method development reports. Draft reports for regulatory filing. Work with Process Analytical and GMP Clinical Operations team to support transfer of analytical test methods for development and clinical support. Work with Assay Validation Team to develop and execute validation protocols. Provide support to Assay Validation Team during and post method transfer (e.g. training, troubleshooting) as needed Perform testing for in-process, drug substance and drug product release and stability samples if needed Participate in cross-functional process development teams representing Analytical Development and Clinical Quality Control (ADQC) Maintain knowledge of current scientific principles and theories. Train other lab personnel as assigned in areas of expertise. Organize activities of self and others as required to achieve project objectives Seek out and evaluate new instruments, methods, techniques and technology platforms to enhance analytical operations

You will need to have:

• Ph.D degree is required. Work experience in the pharmaceutical or biotech industry is preferred.

• Experience with cell-based assays, scientific and practical knowledge of bioassay development for protein therapeutics including monoclonal antibodies and glycoproteins are required.
• Strong scientific background in biochemistry, molecular cell biology with fundamental knowledge of biological pathways. Working knowledge of complement cascade a significant plus.
• Experience with assay development, optimization, qualification and validation for protein therapeutics is a significant plus.
• Knowledge of method development of cell-based assay and ELISA is essential;
• Knowledge of cGMP and quality guidelines is desired. Familiarity with USP < 1032> is desired.
• 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.
• Ability to travel up to 20%, if needed.

We would prefer for you to have:

• Ph.D. in Biochemistry, Molecular and Cell Biology, Immunology or related discipline.
• Hands on experience in bioassay development is required.
• Strong scientific background in biochemistry, molecular cell biology with fundamental knowledge of biological pathway is required.
• Experience in analyzing and characterizing proteins is desired.
• Excellent interpersonal skills are required, as is the strong ability to communicate effectively. The individual must be able to work in a collaborative setting.

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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