Development Scientist III, Analytical Development and Clinical Quality Control

Required Skills and Education

• Ph.D. or master’s degree in Biochemistry, Molecular and Cellular Biology, Immunology, Chemistry, Bioengineering or related discipline with a minimum of 6+ 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
• Familiar with cGMP, ICH, USP and WHO guidelines on regulatory requirements for method qualification and validation
• Strong scientific skills in biochemistry, molecular and cellular biology with good understanding of biological pathways and biotherapeutics’ mechanism of actions
• Ability to take initiative in problem solving and consistently bring 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 JMP and SoftMax Pro
• The ability to independently contribute and oversee the generation of procedures, protocol and reports pertaining to test methods.
• Ability to travel up to 20% to support on-site training and troubleshooting.
• The duties of this role are generally conducted in a 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

Desired Skills

• Experience in microbiology assays (e.g. bioburden, endotoxin, and sterility)
• Technical lead and/or people managing skills highly preferred.
• Has 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)
• When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives 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.
• The annual base pay for this position ranges from $138,392 to $207,590. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
• At AstraZeneca's Alexion division, you'll find an environment where innovation thrives. Our commitment to rare diseases means your work will have a profound impact on patients' lives. With a rapidly expanding portfolio and an entrepreneurial spirit, you'll be part of a team that values connection and collaboration. We empower our employees through tailored development programs that align personal growth with our mission. Join us in driving change with integrity while celebrating diversity and innovation.
• Ready to make a difference? Apply now to join our team at Alexion!

Closing Date