Job Abstract

Position: Senior Engineer, Drug Product Engineering

Location: Gaithersburg, MD

Do you have a passion for Science? Would you like to apply your expertise to impact a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being ambitious, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

AstraZeneca in Gaithersburg, MD:

Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world.  This campus employs more than 3,500 authorities in our field and is only a short drive from Washington, DC. This modern and vibrant scientific campus is the home of R&D and Oncology in the US. Here, we play host to some of the most innovative technology and lab spaces, all designed to inspire collaboration and cross-functional science. We believe employees benefit from being challenged and inspired at work. We are dedicated to creating a culture of inclusion and collaboration.

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. 

Position Summary:

The incumbent will fulfill an important role within the Process Engineering and Packaging (PEP) organization. The PEP function develops clinical and commercial fill/finish processes, combination product assembly processes, and packaging for biopharmaceutical products in the AstraZeneca portfolio. Specific accountabilities include: (1)  leadership of process development for late-stage clinical products; (2) development of robust drug product processes for commercial production (in collaboration with Operations); (3) technology transfer to both internal and outsourced commercial manufacturing; (4) development and maturation of an advanced scale-down fill/finish development lab for technical support of clinical and commercial production.

The incumbent will help oversee the process development and technology transfer of a diverse group biopharmaceutical dosage forms, including liquid and lyophilized formulations, various primary container formats, with specific focus on late stage biologics pipeline. The incumbent must maintain a strong technical culture and be able to establish strong working relationships at internal and external interfaces. This position requires collaborative interactions with AstraZeneca leaders, particularly with the Global Biological Operations (Commercial Operations) organization and internal/external manufacturing sites within the manufacturing network.  Experience working with functions such as late stage formulation development, device development, clinical operations, supply chain, quality and regulatory are also crucial. This individual must be able to optimally lead in a matrix environment and be able to influence broadly internally and externally.

Major Duties and Responsibilities:

• Provide technical and strategic leadership and management for the development of drug product processes for late stage programs. Scope includes accountability for, development and technical support of clinical and commercial biologics Drug Product processes, technology transfer to internal and outsourced manufacturing and ad-hoc technical support for commercial production as needed
• Apply scientific and engineering knowledge and tools to issues and problems arising during development and execution of processes
• Drive a culture of innovation and high-quality science and engineering
• Lead technology development and improvement initiatives to improve project execution efficiency
• Broadly influence and educate senior leaders and the larger AstraZeneca functional areas and product teams on drug product development
• Support sustainability initiatives within PEP to meet AstraZeneca’s carbon-negative ambition

Education Requirements:

B.S., M.S. or Ph.D. in Chemical Engineering, or other relevant Engineering field, Pharmaceutical Sciences, or related field with related experience in the biopharmaceutical industry.  Strong technical and scientific skills with proven experience in development of drug product manufacturing processes for biologics in primary containers and devices.

BS: 8+ years relevant experience

MS: 5+ years relevant experience

PhD: 2+ years relevant experience

Knowledge, Skills and Experience Requirements:

• Drug product process development and characterization
• Strong knowledge of QRM principles and tools
• Experience in CMC aspects of biopharmaceutical development
• Demonstrated ability to work in a collaborative team environment across multiple technical functions
• Strong aseptic processing knowledge (Annex 1 and similar)
• Process validation execution
• Ability to work independently with minimal direct oversight
• Ability to lead up and influence senior partners
• Experience with tech transfer
• Non-conformance investigation and root cause analysis
• Corrective/Preventive action implementation

Desired Skills:

• Experience with regulatory agency interactions or responses to regulatory queries
• Strong statistical background, including SPC and DoE methodologies
• Knowledge of six sigma principles and tools
• Knowledge of combination product and/or medical device development and associated design controls
• Experience with a variety of biologic modalities (mRNA, adenovirus delivery, CAR-T therapies, antibody-drug conjugates, etc.)
• Experience with formulation development
• Experience with lyophilization development, characterization and scale-up

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering groundbreaking methods and bringing unexpected teams together.

We offer a competitive Total Reward program including a market driven base salary, bonus and long term incentive. We also provide a generous paid time off program and a comprehensive benefits package! If you have the determination to create a culture of courageous leadership, creativity and collaboration, we want to hear from you!

AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or parental leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. We believe that the more inclusive we are, the better our work will be.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three 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. We are eager to know more about you. If you are interested in learning more about us, apply now!

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