MSAT Senior Specialist, Purification
AstraZeneca. We are a global, science-led, patient-focused pharmaceutical company. We are dedicated to transforming the future of healthcare by unlocking the power of what science can do for people, society and the planet.
MSAT SENIOR SPECIALIST, PURIFICATION (12 MONTHS FTC)
This is what you will do:
The MSAT Senior Specialist, Purification (12 months FTC) will shape the start-up of the new MSAT Labs at College Park
You will work on the following areas
Generation of documents supporting lab start-up, protocols and reports for lab model and study execution.
Complete technology transfer of lab models, design of experiment and execution to completion supporting continual improvement and process improvements.
Implement systems for the labs, ensuring the highest lab safety standards are observed.
You will be responsible for:
Design and perform studies to support the robustness, process optimization, and characterization of the manufacturing processes, while assessing continual improvements, new material and technology introductions, feasibility assessments that support yield/process improvement initiatives and cost of goods improvement projects that can be replicated robustly at commercial scale, in line with regulatory and commercial manufacturing requirements, including industry standard methodologies.
Perform dropout studies from large scale engineering and technical batches, growing process knowledge, providing recommendations, and problem solving to increase probabilities of technical success, while minimising technical risks.
Perform testing using separation technique, such as HPLC, to support manufacturing process and/or MSAT studies.
Provide technical expertise and troubleshooting for manufacturing processes. Design and co-ordinate experiments which support process investigations, and resolution of Cell Culture/Purification process deviations, root cause analysis, and CAPAs to support commercial operations, and studies in support of regulatory changes.
The candidate must possess critical thinking skills, being entrepreneurial, with an ability to integrate data and information to tackle complex problems to maintain robust and improved manufacturing processes. Effectively communicate complex ideas to audiences with varying degrees of knowledge
Maintain knowledge and history of the products & process throughout the entire commercial lifecycle, including development history
You will need to have:
A degree in Life sciences or engineering subject area with experience in (bio)pharmaceutical manufacturing/development/process engineering.
B.Sc with circa 5 years relevant experience.
Technical knowledge of protein purification/filtration in either research or biopharmaceutical manufacturing roles in Technical, R&D, or Process Development/Optimisation.
Working knowledge of cGMP requirements and implement best practices to ensure technical excellence.
Ability to work on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
Strong technical writing skills and statistical analysis.
Ability to travel up to 10%
We would prefer for you to have:
Masters or PhD
Experience of the set-up/operation of equipment sets such as AKTA purification systems, Vmax determination equipment, and small scale TFF systems
Experience of lab start-up, including commissioning and qualification of small-scale process equipment is beneficial
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 authorization and employment eligibility verification requirements.
