Associate Principal Scientist (Upstream), Global Operations- Gaithersburg, MD
Would you like to apply your expertise to impact the Global Biopharma Technology Operations in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!
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. 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. Come and thrive in our vibrant, energizing, connected and encouraging culture and make a difference to patients. Hear from our Senior Leaders about why they know AstraZeneca is a great place to work. https://lnkd.in/g8APibK.
In the Biologics Global Technical Operations (GTO), we work closely with AstraZeneca's manufacturing network of internal sites and external manufacturing partners (CMOs), our colleagues in R&D, Quality, Regulatory, Supply Chain, and Commercial to provide technical leadership to ensure delivery of quality products to our patients and support our product pipeline. Our Drug Substance (DS) manufacturing network is growing rapidly to keep pace our growing portfolio of commercial biologics products supplied worldwide. We are seeking a highly motivated Upstream scientist with significant commercial cell culture manufacturing /process development experience to join the GTO DS team.
This role is at the Associate Principal Scientist level and will report to the Director, GTO Drug Substance (Upstream). In this role, you will provide technical expertise and leadership to lead/support technology transfers (TT's) of DS manufacturing process to CMO sites, drive continuous improvements and share best practices to ensure the network is best in class for commercial cell culture manufacturing. You will connect across internal organizations and CMOs, including site MS&T, R&D, Quality, Supply Chain, and Regulatory functions.
What you'll do:
- Provide upstream technical expertise and leadership to facilitate DS manufacturing and cell banking TTs across the network (AZ internal sites to CMO, from CMO to CMO), including:
- Authoring, review and approval of upstream tech transfer and GMP manufacturing documentation such as risk assessments, gap analyses, batch records, standard operating procedures, sample plans, process performance qualification (PPQ) protocols.
- Design and execution of TT strategy, including small-scale runs, bioreactor scale-up, gassing strategy.
- Monitor process performance and support resolution of deviations, including remote or on-site support as necessary during execution of Engineering, PPQ, and Pre-approval inspection batches.
- Authoring of relevant sections of regulatory submissions and response to regulatory authority questions.
- Lead/support the site technical teams to drive alignment and implementation of best practices across the network to drive continuous improvements:
- Monitor trends in cell culture mfg. across the network site, develop systems and tools for data visualization.
- Provide technical expertise for resolution of major deviations, lead/support implementation of cross-site improvements.
- Stay abreast of the latest technologies used in Biologics with a view commercial feasibility for AstraZeneca commercial product portfolio and pipeline, including continuous manufacturing, antibody drug conjugates, cell therapies and other new modalities.
- Work closely with internal R&D and MSAT teams to Integrate new technology into existing GMP manufacturing environments at relevant CMO sites.
- Degree in an engineering or scientific discipline with experience in biopharmaceutical Manufacturing Science and Technology/ late phase development, MS or PhD is desirable:
- B.S with 12+ years of experience
- M.S. with 8+ years of experience
- PhD with 6+ years of experience
- Extensive technical knowledge of commercial biologics manufacturing with strong focus on mammalian cell culture processes (large scale bioreactors, media development and harvest operations). Prior experience with late phase DS process development, Process/facility validation and regulatory authority submissions/ global technology transfers/commercial Manufacturing Science and Technology is a plus.
- Experience in Upstream process data analysis and troubleshooting issues with the bioreactor cell culture performance , CFD analysis, Scale up, Upstream raw materials (cell culture media, plant based hydrolysates, and yeastolate) etc.
- Broad understanding of Chemistry Manufacturing and Controls (CMC) activities and responsibilities with respect to TT, prior experience as a lead/technical expert in international TT or authoring of regulatory dossier sections is a plus.
- Knowledge of GMP manufacturing principles and documentation.
- Previous experience with statistical analysis and/or modeling: JMP, Minitab, Spotfire, SIMCA, and/or Discoverant is a plus.
- Ability to apply critical thinking to solve problems and work independently.
- Strong interpersonal and communication skills.
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 recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, groundbreaking cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.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 an excellent fit, please share this posting with them.Find out more on Social Media:
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