Senior Scientist, Drug Product Technology Steward (Fill/Finish) - GTO
At AstraZeneca, we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s outstanding skills with those of people from all over the globe.
As a Senior Scientist, Drug Product Technology Steward in Gaithersburg, MD, you will play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. You will be recognized internally and externally as an expert in your specialist area and an in-demand problem solver for key technical challenges within the drug product space.
This role will be leading sophisticated Drug Product technology transfers, commercial scale-up, process validation and lifecycle management aspects of biological drug products and assembly of medical devices.
At our Gaithersburg facility, we create life-changing medicines for people around the world. The modern, vibrant scientific campus employs more than 3000 specialists in our field, and is only a short drive from Washington, DC. The campus is filled with ground breaking and cutting-edge technology. Our lab spaces were built to facilitate collaboration, interaction and cross functional science. We believe employees benefit from being challenged and inspired at work. We offer everything from bean bag rooms for creative brain storming, game rooms and Zen garden to treadmill stations and regular campus happy hours.
The Gaithersburg site also offers a variety of amenities to help with efficiency and keeping 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.
Join AstraZeneca and help us deliver life changing medicines! Be among our employees who continue to make us an innovative company that stands firmly among the leaders in BioPharmaceuticals.
- Lead Drug Product Technology Transfer and scale-up projects as part of a Drug Product Tech Transfer team, to achieve targets in a timely fashion and to agreed quality standards.
- Provide Technical oversight and resolution of any drug product related technical issues on commercial products.
- Deliver indirect scientific or technical mentorship and leadership to Engineers and Technicians to enable them to optimally meet their project objectives.
- Provide technical expertise in process equipment and qualifications in start-up of new manufacturing sites.
- Manage continuous improvement projects, design changes and lifecycle of commercial drug products in working with other relevant Global Tech Ops teams.
- Collaborate with Biological Process Development to scaleup and transfer new drug product processes
- Ensure that work is performed in accordance with appropriate quality and compliance standards, e.g. QSR/ISO/MDD/GMP/GLP and SHE requirements.
- Represent the technical operations function on drug product technology topics in cross-functional development teams, ensuring the provision of appropriate data (technical, resource & budgetary).
- Maintain an awareness of the status of core technical challenges and opportunities in area of expertise for the current combination product portfolio.
- Create and maintain control strategies, design and risk management documentation
- Work collaboratively to build technical communities.
- BS in Engineering or relevant scientific field
- 10+ years of industry experience
- Technical experience in drug product fill/finish essential
- Experience of working with biological products (Biologics/Vaccine)
- Demonstrated experience developing and/or transferring drug products within a pharmaceutical environment.
- A detailed understanding of the principles and concepts in relation to parenteral/ drug product technology development and lifecycle management.
- Project management, innovation skills, and a thorough understanding of critical unit operations involved in drug product manufacturing.
- An in-depth knowledge of relevant compliance systems as appropriate to own function.
- Good scope of knowledge of the overall drug development process from discovery through to launch.
- Have experience of technical supervision, coaching and mentoring or leading small matrixed teams of people or scientific projects.
- Evidence of strong communication skills and of building good relationships with cross functional team members and customers.
- Proficient experience in Microsoft Windows applications, Risk- and Change Management Tools and methodologies
- Ability to travel 25% of the time; Typically within supported region, but may include some global travel within US, Europe and Asia.
- MS/PhD in Engineering or relevant scientific field preferred
- 6+ years of experience with MS; 2+ years with PhD
- Experience with medical device / combination product assembly in manufacturing or development role is a plus
- Advantageous to have experience in preparing regulatory documentation (ideally in CTD format)
Next Steps – Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
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.