Senior Scientist, Purification Process
1 month ago
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 ground breaking technology and lab spaces, all crafted to inspire collaboration and cross-functional science. We believe employees benefit from being challenged and inspired at work. We are dedicated to crafting 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:
AstraZeneca has an opening for a Sr Scientist in Gaithersburg, MD in the Purification Process Sciences-Technical Transfer team (PPS-TT). We are seeking a highly motivated downstream technology transfer and manufacturing support professional. This position will be responsible for transfer of downstream processes from development into clinical and commercial manufacturing. Members of the TT group within this department work closely with the process development scientists (located in the US and UK), clinical/commercial manufacturing organizations, CMOs, and QA to ensure appropriate scale up and transfer of clinical and commercial processes to manufacturing production.
Main Duties & Responsibilities:
• Transfer multiple projects as downstream tech transfer project lead/ representative. Serve as downstream process SME to perform fit-to-plant, process risk analysis, timely generation of tech transfer documentation, batch record review/approval, technical collaboration with receiving organizations, campaign monitoring and support, performance analysis and interpretation, investigation support, campaign summary report authoring, and routine presentations to multi-functional teams and the management
• Build and maintain effective working relationships with internal stakeholder groups and external CMOs to successfully advance AZ’s Biologics portfolio. Proactively addresses risks/issues to avoid non-conformances and enable efficient transfers
• Serve as subject matter expert and provide technical support to manufacturing within AZ and external partners
• Effectively communicate and collaborate in a matrix team setting to implement technical solutions
• Author, review, and approve technical documents, CMC sections of regulatory submissions (INDs/BLAs), and responses to questions from health authorities.
• Contribute to the improvement of the tech transfer business processes through idea generation and implementation activities
• Position may require weekend work and/or periodic late-night calls (manufacturing support or international collaborations). Position may require travel to CMOs or other AZ sites (domestic and international).
Education & Experience Requirements:
Education: Minimum BS or MS in an engineering or scientific field such as biological sciences. A focus in a process engineering field (, chemical, or biochemical engineering) is preferred but not required. The candidate must have industry related experience.
Senior Scientist: (BS and 10+), (MS and 8+), (PhD and 2+) years
Required Skills:
Downstream Technical Transfer and process development experience Comprehensive knowledge of chromatography columns, virus and sterilizing-grade filters, and TFF membranes (bench, pilot and production scale) Fundamental understanding of downstream unit operations such as affinity, ion exchange, and hydrophobic interaction chromatography, low pH and surfactant-based viral inactivation, virus filtration, and UF/DF Working knowledge of scale-up/scale-down principles Broad understanding of CMC activities and responsibilities with respect to TT Knowledge of GMP manufacturing principles and documentationDesirable for the role
Experience in a cGMP-regulated environment and/or large-scale bioprocessing laboratory Experience with biopharmaceutical modalities in addition to recombinant proteins and/or monoclonal antibodies such as antibody-drug conjugates, viral products, and/or nucleic acids Knowledge of commercialization activities (process characterization, validation, BLA preparation and inspection support) for biopharmaceutical products Experience transferring and/or supporting commercial products Skilled in conducting complex transfer/process development/technology development projectsWhy AstraZeneca?
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Date Posted
05-Jun-2024Closing Date
Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.-
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