Tech Transfer-Project Manager-Clinical Fill Finish
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:
Clinical Fill Finish (CFF) is one of six functional units that make up Logistics & Clinical Supply (LCS). The six integrated units of LCS work together to develop agile supply solutions to ensure clinical delivery meets the portfolio demand.
The primary responsibilities of the CFF function include the following:
- Fill of bulk Drug Substance into Drug Product and device assembly (clinical dosage forms)
- Lead clinical product tech transfer activities to internal and external sites
- Oversee fill/finish and device assembly activities and provide manufacturing support
Main Duties & Responsibilities:
- Lead technical transfer of Drug Product fill finish and device assembly operations to internal and external (vendor) sites for multiple projects supporting Phase 1 to Phase 3 supply.
- Act as the project manager for the internal technical transfer team (sending unit) consisting of development functions (formulation, process, device, analytical, project management) and QA. Manage timelines and activities internally, communicate goals and track deliverables at the receiving site. Manage technical transfer documentation effectively. Some travel to manufacturing sites based in the US & Europe may be required.
- For assigned projects represent CFF activities at the Supply Continuity Team (SCT), and support the LCS Program Manager at other cross-functional project team meetings as may be required (e.g. CMC team). Contribute to overall supply planning, including Drug Product format , and agreement of detailed distribution plans for Drug Substance, Drug Product and samples.
- In consultation with the LCS Program Manager develop and execute a fill and re-supply strategy of the Drug Product for assigned projects ensuring appropriate scheduling and delivery of Drug Product supplies are in line with the project team timelines.
- Review vendor batch records and provide oversight for all specified manufacturing operations undertaken on behalf of Clinical Fill Finish (CFF)
- Throughout ensure cGMP compliance and all its related elements in documentation, reports and records
- Mentorship of LCS team members with no direct people management responsibility
Education & Experience Requirements:
Requires a degree in basic / applied science or engineering. Ph.D. with 0+ years OR Master's degree and 8+ years OR Bachelor's degree and 10+ years experience in the pharmaceutical industry as appropriate (biotechnology area preferred).
Equivalent level of training in service may also be considered.
The CFF Manager will have appropriate direct experience in a development or technical operations environment in the pharmaceutical, scientific or health care product industry.
Specific experience in the management, development or preparation of aseptically produced products is desirable. Suitable experience may include development of fill-finish, lyophilization, device assembly, or related processes.
Candidates with formulation development experience , especially biopharmaceuticals, looking to transition from a laboratory environment to a technical role with a project management focus would be considered. We will also consider strong candidates from a device development or small molecule parenteral background.
Though this position is in Development, we will consider strong candidates with GMP processing experience, e.g. in technical services, project management, QA, or supplier management.
- This position requires a high level of commitment, flexibility, initiative and the ability to work with minimal direct supervision.
- Highly organized individual who possesses excellent attention to detail, and demonstrates strong skills for planning, coordination, teamwork, and communication.
- Experience organizing and leading cross-functional teams is valuable.
- Ability to handle multiple ongoing work streams in an organized fashion.
- Proficiency in Microsoft Outlook, Word, Excel and Power Point is expected.
- Knowledge of fill-finish unit operations including formulation, mixing, filtration, fill and lyophilization
- Combination product assembly
- Experience of vendor management
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.