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 entrepreneurial, 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.
About AstraZeneca in Gaithersburg, MD:
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. 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 cutting-edge 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.
Introduction to role:
Join us at AstraZeneca as a Senior Director in our Process Engineering and Packaging (PEP) organization. This strategic leadership role is pivotal in developing clinical and commercial fill/finish processes, combination product assembly processes, and packaging for biopharmaceutical products in our portfolio. You will be at the forefront of our mission to lead the way for a new breed of solutions-oriented regulators, championing a new approach to Regulatory that supports quick decision-making and balanced risk-taking.
Accountabilities:
Your responsibilities will span across various domains including leadership of R&D business process for technical support of AstraZeneca's commercial biologics product portfolio, liaison between Operations and R&D for streamlined On Market Support results, leading R&D resources required for On Market Support, and development of robust drug product and device assembly processes for commercial production. You will also be responsible for technology transfer to both internal and outsourced commercial manufacturing, and development and maturation of an advanced scale-down fill/finish development lab for technical support of clinical and commercial production.
Essential Skills/Experience:
- BS with 18+ years of experience, an MS with 15+ years of experience or a PhD with 12+ years of experience.
- Recognized leader in drug/combination product process or packaging development.
- In-depth knowledge developing and driving strategies for drug product process development.
- Experience in QRM principles and tools.
- Experience in CMC aspects of biopharmaceutical development.
- Experience with regulatory agency interactions.
- Demonstrated ability to lead / influence cross-functionally and at a senior level within the organization.
- Demonstrated ability to effectively lead and develop professional staff.
- Experience in Medical Device development.
- Strong aseptic processing knowledge.
- Strong Process validation lifecycle strategy and execution skill.
- Experience in leadership of and/or membership of enterprise level committees, initiatives, or task forces.
- Experience advising technical support of marketed drug products and post-approval changes.
- Strong statistical background, including SPC and DoE methodologies.
- Understanding of Lean/Six Sigma.
- Drug product development and tech transfer.
- Knowledge of assembly, label and packaging processes and equipment.
- Experience with novel and new biotech modalities (mRNA, adenovirus delivery, CAR-T therapies, ATMP, antibody-drug conjugates, etc.).
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 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.
At AstraZeneca, we are committed to turning our drug development strategies into reality. We work at all stages of development to translate our life-changing science into medicines to get the best results for AstraZeneca, patients in need, and healthcare professionals. We are a diverse and open-minded team harnessing our different skills and experiences. Our differences enable us to explore new ideas and ways of doing things. It keeps us on our toes and excited for what's next. We are striving for technology adoption and automation to drive efficiencies and new innovations. We believe there's always a better way of doing things. Committed to finding improvements that will impact patients with serious diseases, we are always asking questions, trying new things, and sharing new proposals.
Ready to make a difference? Apply now and join us in our mission to push beyond the traditional and bring life-changing medicines to patients.
Date Posted
03-Sep-2024Closing Date
Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.