Associate Scientist, Analytical Sciences, GMP

Associate Scientist, Analytical Sciences, GMP

Introduction to role

Are you ready to dive into the world of Analytical Sciences within GMP regulations? Join our dynamic team responsible for supporting clinical stage biopharmaceutical products. We manage lot release and stability programs, reference standards, critical reagents, and more. Collaborate with experts across multiple analytical disciplines such as chromatography, electrophoresis, immunoassay, bioassay, and device functionality methods. Work closely with Analytical Sciences development personnel, Clinical Supply Chain, CMC, and Quality Assurance throughout all stages of clinical development.

Accountabilities

• Work as part of a team and contribute to design and/or execution of analytical studies to determine the quality and stability of drug substance and drug products.

• Participate in analytical method development, method qualification and technical transfer activities.

• Execute analytical testing, data review and interpret results according to written procedures.

• Author, revise and/or review SOPs, protocols, reports and other relevant documentation.

• Train junior laboratory personnel and troubleshoot methods and experiments, as needed.

• Maintain laboratory and equipment in accordance with written procedures.

• Perform analytical quality investigations, as needed.

• Participate in/lead cross-functional teams and or process improvement efforts.

• Interpret data, generate reports/presentations and communicate progress to immediate peer group and supervisor.

• Ensure that work is performed in accordance with appropriate safety, cGMP and AZ standards.

Essential Skills/Experience

• A bachelor’s or master’s degree in chemistry, biochemistry or related field is required

• The candidate will have 0-5 years of experience after receiving a bachelor’s degree or 0-2 years of experience after receiving a master’s degree

Desirable Skills/Experience

• Prior experience in a laboratory environment and familiarity with laboratory practices and safety requirements is required.

• Prior experience with analytical methods used for characterization of biopharmaceutical and/or cell therapy products, including, but not limited to chromatography (SEC, IEC, and RPLC), compendial (pH, HIAC, osmolality, etc.), electrophoresis (cIEF, CGE) techniques is preferred.

• Familiarity with cGMP, ICH and USP/EP requirements is desirable.

• Previous experience in a Quality Control environment is desirable.

• Ability to work well independently and on teams across multiple functional areas

• Self-motivated and possess good interpersonal, collaborative, and communication skills.

• Working knowledge of Microsoft Excel, Word, and PowerPoint.

At AstraZeneca, we thrive on tackling complex challenges with a fast-paced and agile approach. Our team is empowered to innovate and experiment, contributing to a comprehensive pipeline that spans the entire drug development process. With countless submissions and engaging projects at your fingertips, you'll be part of a supportive yet challenging environment that encourages learning and growth. We embrace global opportunities across all Therapy Areas, ensuring our work makes a profound impact on patients worldwide.

AI & Operations Lead

Introduction to role

At AstraZeneca, we're redefining what a biopharmaceutical company can be. Our commitment to innovation extends beyond our science to how we operate, bringing cross-functional teams together in pioneering new approaches to deliver life-changing medicines. We are seeking an AI & Operations Lead to revolutionize our operational approach through innovative AI applications and strategic analytics. In this pivotal role, you will drive meaningful change by harnessing advanced technologies to streamline processes, enhance decision-making, and transform complex data into actionable insights that power exceptional business outcomes. As our catalyst for digital transformation, you'll help shape the future of how we deliver on our promise to patients.

Accountabilities

Operational AI

• Drive the implementation of operational AI solutions across various departments to enhance operational efficiency and streamline processes.

• Lead efforts in integrating AI technologies within existing systems to automate routine tasks, resulting in improved reporting accuracy and communication speed.

• Champion the use of AI-driven insights to optimize department workflows, reduce manual workload, and facilitate data-driven decision-making.

• Collaborate with AI vendors and external partners to explore new technologies and tools that can be leveraged to solve operational challenges.

• Collaborate with team members to define key performance indicators (KPIs) and create AI-enhanced dashboards for real-time monitoring of department performance.

Analytics

• Update ongoing finance files and templates looking for automation and simplification opportunities.

• Develop financial analysis and scenarios to inform decision-making.

• Maintain an up-to-date headcount change log database, leveraging automation and stakeholder management to ensure accuracy.

• Track execution of operational budget tasks including cross-charging and eventual HC and transaction auditing.

• Build and maintain comprehensive reports to track spending across various centers, identifying and correcting any deviations as necessary.

• Utilize AI algorithms for predictive modeling to forecast financial scenarios and project performance, aiding in better decision-making.

Process Support

• Ensure documentation for Leadership meetings is completed in time according to meeting and pre-read norms by liaising with presenters and consolidating topics into a unified document.

• Ensure timely updates to key department goal tracking mechanisms including Portfolio Tracking and Scorecard.

• Prepare quarterly or monthly output reports for leadership and department from Portfolio and Scorecard tracking, highlighting changes, improvements, and insights on project performance.

• Use AI to streamline processes, such as travel expense tracking, by automating approval workflows and notifications.

• Maintain and continuously update the travel spreadsheet; prepare communication related to approval and non-approval notifications.

• Facilitate cross-functional workshops or training sessions to improve understanding and usage of tracking tools.

Strategic Transformation Management

• Align cross-functional teams on high-impact initiatives to advance strategic priorities and maximize business value.

• Lead proactive planning and problem-solving to resolve executive barriers, develop creative solutions, and ensure seamless delivery of transformation objectives.

• Champion AI-driven reporting solutions that provide real-time, actionable insights to empower effective decision-making.

• Track progress on key projects and initiatives, providing regular status updates to leadership.

Essential Skills/Experience:

• Bachelor's degree 5+ years of experience or master's degree 2+ years of experience in biology, Chemistry, Pharmacology or Computer Science fields

• Experience in operational roles with a focus on process improvement and efficiency.

• Proven track record in implementing AI or automation solutions within an organization

Desirable Skills/Experience:

• Critical Thinker: Ability to analyze complex processes and identify opportunities for AI-driven improvements.

• Strong analytical skills: Comfort with financial data, KPIs, and predictive modeling.

• Excellent Communication: Strong verbal and written communication skills for collaboration and reporting.

• Project Management: Experience coordinating and managing cross-functional projects.

• Adaptability: Ability to work in a rapidly changing environment and manage multiple priorities.

Other Attributes

• Innovative mindset: Willingness to explore and integrate new technologies to solve operational challenges.

• Team player: Collaborative approach with an enthusiasm for facilitating inter-departmental workshops and training sessions.

Why AstraZeneca?

AstraZeneca offers an inspiring environment where dedication meets opportunity. Here, you can apply your expertise in innovative ways that make a tangible difference. We thrive on collaboration across diverse teams, embracing challenges as opportunities for growth. Our commitment to continuous improvement ensures that every effort contributes to delivering impactful solutions for patients worldwide. With a focus on learning and development, AstraZeneca empowers you to expand your knowledge while making meaningful contributions.

At AstraZeneca, we seize opportunities to innovate and redefine what’s possible in biopharmaceuticals. Our mission to deliver transformative medicines is underpinned by a culture of collaboration, inclusivity, and ambition. Join us in a role where your work directly gives to breakthroughs in oncology, empowering patients and changing lives.

Ready to take the next step in your career? Apply now!

The annual base pay (or hourly rate of compensation) for this position ranges from The annual base pay (or hourly rate of compensation) for this position ranges from $ 71,701.60 to $107,552.40 . 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. ​​

Date Posted

Closing Date

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.