Scientist I/II - CMC Bioprocess Documentation - 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:
Our BioPharmaceutical Development (BPD) department supports the development and advancement of innovative biologics medicines to the clinic across the AZ therapy areas from early research to late stage development.
Within BPD, Cell Culture and Fermentation Sciences (CCFS) designs, develops, optimizes and validates cell culture and fermentation processes for a wide range of biologic products. The team generates optimal cell lines and is also responsible for technology transfers into manufacturing and preparing CMC documentation for regulatory submissions. Cutting edge high throughput scale-down models are employed to develop high-performing media and processes to support production. The team actively implements novel technologies, including automation and analytics, to advance production platform capabilities and drive forward a diverse exciting project portfolio.
Main Duties & Responsibilities:
This role is to manage biologic CMC upstream documentation to support regulatory submissions to health authorities. The major responsibilities include:
- Author, verify, and review cell bank, virus seed, and unprocessed bulk testing sections of regulatory submissions and supporting reports in collaboration with the relevant subject matter experts in CCFS. Rapidly provide written responses to relevant questions from regulatory agencies.
- Provide project planning oversight for timely scheduling of cell line testing, report writing, and documentation to allow manufacturing schedule to proceed.
- Procure and review relevant raw materials documentation associated with safety of animal-derived components used during cell line development and drug substance manufacturing. Perform relevant TSE-BSE risk assessments and review with internal stakeholders. Ensure compliance with health authority guidance.
- Provide support for potential due diligence activities. Assess documentation for in-licensed projects and production processes. Identify any gaps in necessary documentation or testing requirements to maintain compliance with regulatory guidance. Assimilate this information into controlled and versioned document management systems.
- Understand the processes needed for TSE-BSE risk assessments in relation to the use of animal derived materials and product safety.
- Maintain and apply knowledge as a subject matter expert on CMC regulatory guidance, CMC documentation practices and CMC authoring tools. Advise and train scientists on best practice to ensure compliance.
Education & Experience Requirements:
- BS/MS/PhD in Biotechnology, Biochemistry, Cell Biology, Virology, Immunology or Biological Sciences.
- Sci I: Bachelor's degree and 10+ years or Master's degree and 8+ years or PhD and 0+ years of relevant industry experience.
- Sci II: Bachelor's degree and 13+ years or Master's degree and 10+ years or PhD and 3+ years of relevant industry experience.
- Relevant industry experience is essential for this role.
- Proven experience in preparing upstream CMC documentation (specifically around cell bank, virus seed lineage, unprocessed bulk testing and animal-derived materials risk assessments) for biologics regulatory submissions for clinical trials and commercial applications, familiarity with the relevant regulatory guidance frameworks, and familiarity with adventitious agent safety testing (viruses, microbes, prions).
- Meticulous attention to detail.
- Excellent communication skills, both written and verbal.
- Aptitude for working with electronic document management systems using good organizational skills.
- Able to work effectively with cross-functional teams and to establish effective working relationships with internal/external stakeholders, contract manufacturing organizations, outside testing labs, and vendors.
- Able to work in a fast-paced and dynamic working environment with flexibility to support multiple project activities in parallel and set the proper priorities.
- Experience authoring upstream CMC sections of a commercial marketing application for biotherapeutic protein products and authoring health authority responses.
- Able to review cDNA sequencing test results as a subject matter expert. Support appropriate trouble shooting with any testing issues and review new testing protocols as required.
- Familiarity with the various pharmacopeial regulations governing cell bank and virus seed biosafety testing and understanding of the appropriate test methods.
- Familiarity with regulatory guidance and submissions for vaccines and cell and gene therapies.
- Ability to lead innovation and change to improve efficiency of processes within CCFS that support regulatory submissions.
- Ability to train and mentor scientists in CMC documentation and processes and biosafety testing.
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.