At AstraZeneca, we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing.
In 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. We are currently searching for a Scientist position based on our Frederick Drug Substance manufacturing facility.
Our Frederick Drug Substance (DS) manufacturing facility (FMC) creates life-changing medicines for people around the world. The Manufacturing Science& Technology (MS&T) team at FMC ensures technical oversight and leadership to drive excellence in manufacturing. We make a direct contribution to treating people with cancer, respiratory and autoimmune conditions across the globe. From catered site festivities to competitive events, community outreach activities, environmental and wellness showcases and team-building events, we take time to recognize our achievements. The Frederick Manufacturing Center is dedicated to building a culture of inclusion and collaboration. We are also an award-winning employer and has been recognized as a 'Top 50' Business in Frederick, and Frederick County's 'Best Place to Work' distinction in 2015 and 2019.
As a Drug Substance Scientist, you will provide technical support to AZ's commercial and late phase product portfolio. You will work with colleagues in MS&T and GTO organizations to support technical initiatives or investigations across the AZ DS manufacturing network (FMC and CMOs). Specifically, this position is responsible for execution of lab studies related to Drug Substance process operations. These may include productivity improvement projects, deviation investigations, or studies requires for technology transfers, or potential process/raw material changes.
What you'll do:
- Contributes to the plans and designs of lab studies and provides general scientific advice on specific topics to the team. Projects may include qualification activities for secondary supplier sites, evaluating raw material variability, and studies to support commercial manufacturing and technology transfer processes.
- Manages own work to ensure that agreed targets are met in a timely manner and to agreed quality standards, communicating progress appropriately
- Performs relevant experiments and interprets results based on a standard methodology
- May modify or improve processes and systems, depending on purpose of experiments
- Assesses and reports data, with little or no guidance, in a clear and concise manner, with a clear understanding of its implications within the overall context of drug development
- Discusses and defends the findings of experiments at follow-up meetings, or corresponding forums
- Liaises with colleagues from other disciplines with the purpose of discussing project-related matters, sharing experiences and reporting progress
- Develops own level of competency by reading articles, collaborating with peer scientists or through contacts by other internal groups
- Minimum of Bachelor's Degree in Science or related field.
- Bachelor's and 6+ years of experience
- Master's Degree and 4+ years
- PhD in a scientific field.
- Hands on experience in biologics process development and lab-scale/pilot scale work
- Drug Substance Commercial and Technology Transfer within upstream and downstream operations preferred.
- Previous experience with statistical analysis and/or modeling a plus (JMP, Minitab, SIMCA, and/or Discoverant).
- Knowledge of GMP manufacturing principles and documentation
- Ability to apply critical thinking to solve problems and work independently
- Strong interpersonal and communication skills.
- Experience in using Lean/continuous improvement methodology for process improvement.
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 a great fit, please share this posting with them.Find out more on Social Media:
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About Operations https://www.youtube.com/watch?v=gak5Ham8oUw