Development Scientist III, Analytical Development and Clinical Quality Control

Introduction to role:

The Development Scientist III position is a technical position responsible for development, qualification, and optimization of bioassay (biological activity/potency assay of drug candidates) and process-derived impurity methods (HCP, residual Protein A, residual DNA), in order to support release and stability testing of biotherapeutic products, and also formulation and process development. This position also supports regulatory filing (IND and BLA) and responses to Health Authorities’ queries.  Participation in methods transfer, validation, troubleshooting and investigations of bioassay and impurity methods to internal and external laboratories may be required.  In addition, this position is expected to interact regularly with other functional areas, such as Research, Biologic Drug Substance Development, and Injectable Drug Product Development groups as well as Manufacturing, Quality Assurance and Quality Control groups. 

Accountabilities:

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

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

• Makes scientific/technical proposals of strategic nature based on corporate or project objectives and understands the impact of their decisions on corporate/project objectives. 

• Authors SOPs, study plans, protocols, method development/qualification reports. Drafts corresponding IND and BLA sections for regulatory filing and authors responses to health authority queries and requests. 

• Leads cross-functional scientific/technical problem-solving efforts. Carries out authentic, persuasive scientific/technical presentations of strategic nature in cross-functional environment. 

• Assists with prioritizing technical work efficiently to meet project timelines. 

• Strong ability to multi-task and achieve milestone deliverables across multiple projects. 

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

• Establish continuous improvement systems based on lessons learned and incorporate improvements into ways of doing business. 

• Positively contributes to improving the working environment and engaged in on-going Alexion cultural improvement efforts. 

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!

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Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.