Director, Analytical Technical Lead

At AstraZeneca, we turn ideas into life changing medicines. Working here means being ambitious, thinking big and working together to make the impossible a reality. We're focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we believe we can really change the course of medicine and bring big new ideas to life.

Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world. This campus employs more than 3,500 experts in our field and is only a short drive from Washington, DC. The Gaithersburg site offers a variety of amenities to help boost productivity and help keep our employees happy and healthy. This includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria and copy center. This is where you’ll find newly-designed, activity-based work spaces to suit a variety of working styles while increasing collaboration between teams. Come and thrive in our vibrant, energizing, connected and encouraging culture and make a difference to patients.

In Biologics Global Technical Operations (GTO), we work closely with AstraZeneca’s manufacturing network of internal sites and external manufacturing partners (CMOs), our colleagues in R&D, Quality, Regulatory, Supply Chain, and Commercial to provide technical leadership to ensure delivery of quality products to our patients and support our product pipeline.

As an analytical technical lead (ATL) in GTO, you will be the technical steward for all analytical aspects of AstraZeneca’s pipeline products. The position acts globally to align QC sites at both internal and external analytical testing nodes. The position serves as the owner of the analytical methods for a subset of products and is responsible for the lifecycle management of those methods and activities supporting the analytical methods.

In this capacity, you will work closely with QC testing sites (internal or external), other GTO functions, R&D, Quality, Regulatory, and Supply Chain organizations. For this position there is a strong focus on interactions with AstraZeneca’s development organization and global QC testing sites.

What you’ll do:

• Be responsible for the analytical methods for a specific AstraZeneca pipeline products, with responsibilities for method performance monitoring, lifecycle management, and switch management where needed

• Represent analytical activities on the commercial CMC team

• Work closely with the development and commercial CMC teams to define and implement the analytical strategy for products.

• Own the readiness of analytical methods for a product, ensuring that the QC methods for a product are ready for validation and use in a QC testing environment

• Contribute to continuous improvement projects with analytical impact, including changes in analytical technologies and improvements in internal ways of working to build a more efficient analytical organization

• Partner with team members from with GTO and across the AstraZeneca organization to drive and deliver right first time analytical for commercial products.

• Support preparation of regulatory submissions, oversight during inspections and audits, and respond to questions from regulatory bodies.

• Ensure that work is performed in accordance with appropriate quality and compliance standards, e.g. QSR/ISO/MDD/GMP/GLP and SHE requirements as well as to ICH expectations.

• Maintain an awareness of the status of core technical challenges and opportunities in analytics, with focus on changes in regulatory guidance and expectations in these areas.

• Work collaboratively to build technical communities.

• To succeed in this role, you will need to be self-motivated, innovative, have strong technical and communication skills, and a understanding of biologics quality control, analytics, and quality requirements

Essential for the role:

• Degree in an engineering or scientific field with experience in biopharmaceutical manufacturing/development/process engineering:

  • B.S with 8+ years of experience

  • M.S. with 5+ years of experience

  • Ph.D. with 3+ years of experience

• Proven technical knowledge of biologics quality control testing for release, stability and regulatory submission support required.

• Understanding of regulatory authority expectations and quality compliance with regard to analytical methods and QC