Development Scientist II, Analytical Development & Quality Control

Job Title: Development Scientist II, Analytical Development and Clinical Quality Control

Introduction to role:

Are you ready to make a difference in the world of biotherapeutics? As a Development Scientist II, you will play a crucial role in the development, qualification, and optimization of bioassays and process-derived impurity methods. Your work will support the release and stability testing of biotherapeutic products, as well as formulation and process development. You will also be involved in non-GxP sample testing, regulatory filings, and responses to agencies. This position requires regular interaction with various functional areas, including Research, Biologic Drug Substance Development, Injectable Drug Product Development, Manufacturing, Quality Assurance, and Quality Control groups.

Accountabilities:

You will be responsible for:

- Development, optimization, and phase-appropriate qualification of bioassays to evaluate quantitative biological, biochemical, and cellular activities for therapeutic proteins

- Phase-appropriate qualification for process-derived impurity methods and impurity work strategy to support process development, product release specification, and regulatory filing

- Making scientific/technical proposals of strategic nature based on corporate or project objectives, understanding the impact of decisions on these objectives

- Authoring SOPs, study plans, protocols, method development/qualification reports, and drafting corresponding IND and BLA sections for regulatory filing

- Leading cross-functional scientific/technical problem-solving efforts and conducting persuasive scientific/technical presentations in a cross-functional environment

- Assisting with prioritizing technical work efficiently to meet project timelines

- Multi-tasking and achieving milestone deliverables across multiple projects

- Exploring new cutting-edge technologies and automation to improve throughput and efficiency of bioassay and impurity methods

- Establishing continuous improvement systems based on lessons learned and incorporating improvements into business practices

- Positively contributing to improving the working environment and engaging in ongoing Alexion cultural improvement efforts

Essential Skills/Experience:

You will need to have:

- Ph.D. degree with a minimum of 2-5 years of analytical method development and qualification experience in pharmaceutical or biotechnology setting, with high preference in ELISA binding assay, enzymatic assay, cell-based assay, and process-derived impurity methods

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

- Familiarity with cGMP, ICH, USP, and WHO guidelines on regulatory requirements for analytical method development, qualification, and validation

- Strong scientific skills in biochemistry, molecular and cellular biology with a good understanding of biological pathways and biotherapeutics’ mechanism of actions

- Ability to take initiative in problem-solving and consistently bring an independent scientific approach to method development

- Excellent interpersonal skills and a strong ability to communicate effectively

- High level of proficiency in MS Office software including Word, Excel, Outlook, Visio, PowerPoint, and SoftMax Pro

- Ability to independently contribute to and oversee the generation of procedures, protocols, and reports pertaining to test methods

- Ability to travel up to 10% to support on-site training and troubleshooting

- Capability to work comfortably in a controlled lab environment with biological, infectious, and hazardous materials; lift/carry 15/30 pounds unassisted/assisted; gown/de-gown PPE; use a computer; engage in communications via phone, video, and electronic messaging; engage in problem-solving and non-linear thought; collaborate with others; maintain general availability during standard business hours

Desirable Skills/Experience:

We would prefer for you to have:

- Ph.D. degree with equivalent level of experience in Biochemistry, Molecular and Cellular Biology, Immunology, Chemistry, Bioengineering or related discipline

- Technical lead and/or people managing skills highly preferred

- Knowledge of other technical areas within ADQC/PDCS organization (Other analytical methods such as LC, CE and compendial methods within ADQC; process development and formulation development within PDCS)

At AstraZeneca's Alexion division, you will join a team that is dedicated to making a difference in the lives of patients with rare diseases. Our innovative spirit drives us to continuously improve and create meaningful value. We offer an energizing culture where you can grow professionally while making a significant impact. Our commitment to diversity, inclusion, and patient-centricity ensures that your work here is both fulfilling and impactful.

Ready to join us on this exciting journey? Apply now!

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.