Technical Lead - Tech Transfer/Investigations/New Product Intro - BPD
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.
Summary of the group:
The Manufacturing Transfer and Integration (MTI) team is an integral part of the overall Manufacturing Sciences group in the clinical development and manufacture of medicines within the AstraZeneca Supply Biologics organization. The MTI group supports batch record generation, investigations, tech transfer, manufacturing floor support, and various other critical functions.
Main Duties & Responsibilities:
- Responsible for interpreting, adapting and translating technical drug development information into coherent procedures/instructions.
- Leads investigations, drives corrective/preventive actions.
- Provides technical compliance support, expertise, and training as required.
- Works in team and matrix-oriented environment with cGMP Manufacturing, Materials Management, Engineering & Automation, Technical Services, CMC Project Management, Process Development, Tech Transfer, and Quality functions.
Education & Experience Requirements:
- Bachelor’s degree in a scientific discipline
- Master’s degree preferred
- 8+ years of experience
- cGMP experience required
- Ability to interface with senior internal and external personnel on significant matters often requiring coordination between organizations.
- Authors complex Master Production Records (MPR’s) and Solution Preparation Records (SPR’s) as needed to accurately reflect manufacturing process.
- Authors master specifications for raw materials with more complex challenges.
- Trains junior staff on technical writing/translation of technical information into coherent instructions/procedures.
- Leads manufacturing readiness activities for more complex tech transfers
- Reviews and/or approves documents for technical accuracy and quality assurance
- Lead investigator for complex non-conformances including leading Material Review Board meetings.
- Identifies and troubleshoots complex problems, providing suitable solutions.
- Represents Manufacturing Sciences Organization in cross-functional forums including internal and agency audits/inspections.
- Drives process excellence/continuous improvement initiatives.
- Capable of identifying areas of improvement and driving change through lean principles
- Strong collaborative skills to work in a team environment as well as manage their own tasks/workload for on-time delivery.
- Ability to prepare or commission graphics and illustrations to elaborate on or complement technical writing.
- Ability to author aseptic qualification/media simulation protocols, shipping studies, container closure studies, and other process validation documents for clinical manufacturing.
- Ability to applies knowledge of technical theories and principles on a broad base where analysis of situations or data requires an in depth evaluation of various factors
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 recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.
So, what’s next!
Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it’s yours.
Where can I find out more?
Check out our landing page for more information on our BPD group https://careers.astrazeneca.com/bpd
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AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.