Associate Director, Drug Product Technology - 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.
In the Associate Director, Drug Product Technology role, you will be responsible for technical aspects of commercial operations for marketed drug products such as product revalidation, transfer or improvements of commercial products and new product introduction.
You will be a part of the Global Technical Operations team—responsible for working with commercial operations to support existing commercial products and working with R&D to verify that drug product processes are scalable and can be efficiently manufactured in commercial operations. As the AD, you will also work with technology transfer teams to facilitate transfers of late stage processes to drug product external manufacturing vendors (CMO). It will be your responsibility to ensure that the process is commercially viable as demonstrated by successful process performance qualification studies, BLA approval, and ultimately a successful product launch.
Our Gaithersburg, Maryland facility creates 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. It is filled with ground breaking technology. Our lab spaces were built to facilitate collaboration, interaction and cross functional science.
We believe employees benefit from being challenged and encouraged 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 offer a variety of amenities to help boost efficiency and to keep our employees happy and balanced. 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 innovation-driven company that stands firmly among the leaders in Biopharmaceuticals.
- Interacts with multidisciplinary and multi-site groups, which may include CMOs, technology transfer teams, external vendors, and other strategic suppliers. ADs are responsible for communicating status to the CMC teams through representatives. Once the product is licensed by the regulatory authorities, the responsibility for commercial manufacturing transitions to another organization within AstraZeneca.
- Participates in drug product technology transfer teams when AZ Biologics is working with CMOs.
- Collaborates with Engineering, Supplier Quality, and other functions to ensure that appropriate equipment is qualified and available for manufacturing and device assembly if appropriate.
- Facilitates alignment of Development and Operations technical decisions necessary through completion of Process Validation to ensure commercial viability of the manufacturing process.
- Assists with device manufacturers for commercial product.
- May participate in vendor visits of potential drug product and device companies.
- Communicates pertinent information to appropriate representatives to ensure successful product transfer and commercialization.
- Assists to develop long term drug product manufacturing strategies in conjunction with Operations, BioProcess Development, and others.
- Reviews and approves site and supplier changes to materials/specifications
- Responsible for technology transfer of device technology as receiving group for biologics operations;
- Provides commercial operations support during lifecycle for process improvement and revalidation of transfers.
- Develops and transfers robust processes to internal or external manufacturing sites
- Provides review and oversite of capital equipment spends associated with commercial scale-up purchases. Influence decisions at sites in respect to investments and asset utilization
- Provides support for regulatory submission documentation as required
- BS degree in Engineering, Life Sciences or similar field
- 20+ years of industry experience
- Greater than 10 years’ experience in a biotech/pharmaceutical company.
- 5+ years of direct experience with biologics drug product manufacturing, technical support of drug product manufacturing or drug product development experience with some oversight of manufacturing
- The candidate will have a broad based understanding of Operations including Manufacturing Operations, Supply Chain, Quality Assurance, and Quality Control.
- Excellent communication skills with the ability to work optimally in cross functional teams and effectively influence team members.
- Ability to travel at least 25% of the time; Typically within supported region, but occasionally global (US/Europe/Asia)
- MS degree or PhD in Engineering, Life Sciences or similar field preferred
- 17+ years with MS Degree
- 10+ years with Ph.D. Degree in Engineering or life sciences
- Statistical analysis experience a plus
- Experience commercializing a biological combination product is a plus
- Experience support functional testing of devices and/or device complaints evaluation is desired.
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.