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Development Scientist III, Bioanalytical and Biomarker Development

Location New Haven, Connecticut, United States Job ID R-185821 Date posted 28/11/2023

This is what you will do:

The primary responsibilities of development scientist III include: owning cross-functional projects or initiatives. Design and implement innovative scientific experiments for development, validation and drive robust bioanalytical methods capable of detecting drug levels or anti-drug antibodies (ADA) in clinical and nonclinical study samples;

Develop and implement new and novel protocols to address specific issues and/or troubleshoot and improve current existing assay platforms towards being more robust and transferable. The candidate must possess critical thinking skills with an ability to integrate data and information to solve sophisticated problems to advance drug discovery and development programs. Effectively be able to communicate complex ideas to audiences with varying degrees of knowledge.

You will be responsible for:

  • Require to have GLP laboratory experience, proficient with GLP and GCP regulations, adhere to GLP/GCP guidelines
  • Ligand binding assaydevelopment and validation under GLP guidelines
  • Able to use professional concept and procedures to solve problems in creative, practical and effective ways
  • Able to demonstrate success in technical proficiency, scientific creativity, and collaboration with others and independent thought
  • Problem solving and ability to analyze situation or data requires a review of identifiable factors. Excises judgment within defined procedures and practice for obtaining solutions
  • Can lead an inter-department project or initiative involving other contributors
  • Able to communicate across groups and within cross-functional teams
  • Training and oversight of associate scientists
  • Ability to be the single departmental point of contact
  • Maintains high level of professional expertise through familiarity with scientific literature
  • Able to work with CRO, able to anticipate and solve problems

You will need to have:

  • Ph.D. in Life Sciences or related field with 8 years of relevant laboratory experience or Bachelors/Masters degree in relevant scientific field with 15+ years relevant laboratory experience
  • Good understanding of bioanalytical assay development, validation, and associated data analysis
  • Hands-on experience with ELISA, Gyros, MSD and other assay platforms and technologies and experience in critical reagent identification, generation and characterization
  • Strong knowledge and experience in the development and validation of immunoassays, including pharmacokinetic (PK), immunogenicity and biomarker assays to support nonclinical and clinical studies for different therapeutic modalities
  • Working knowledge of regulatory guidance documents that pertain to the bioanalytical field
  • Good writing and oral communication skills including good presentation skills
  • Hands-on experience with bench experiments and data analyses
  • Managing colleagues, working effectively in project teams and providing technical input to colleagues
  • Can lead an inter-department project or initiative involving other contributors
  • The duties of this role are generally conducted in an lab environment. As is typical of a lab-based role, employees are required, 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 developing and validating cell based Nab assays
  • Experience with various techniques applied to Cell and Gene therapy bioanalysis

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.

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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