Sr. Scientist I, Plasmid Manufacturing, Viral Vector Product Development

Sr. Scientist I, Plasmid Manufacturing, Viral Vector Product Development

Location:

Durham, NC  

Global Level:

GCL D

This is what you will do:

This position will play a key role in Alexion’s Viral Vector Product Development Plasmid Manufacturing team, interacting with internal teams within the Genomic Medicine and Product Development Clinical Supply groups. The Senior Scientist will be responsible for supporting plasmid manufacturing.

You will be responsible for:

• Leading plasmid manufacturing for both small scale, high-throughput and large scale fermentation.
• Developing small-scale high-throughput processes to generate high quality material for early screening and development work
• Guiding the development of novel and innovative methods for plasmid purification and quality assessment
• Establishing rapid and robust testing methods for assessing plasmid stability
• Identifying and troubleshooting issues that arise during the different processes, proposing and implementing solutions to optimize efficiency and success rates.
• Leading technical projects and routinely managing the work of others to facilitate technical milestone deliverables.
• Providing training and guidance to junior colleagues.
• Presenting data and findings to diverse groups both internally and externally facing
• Supporting the authoring of regulatory documents, technical protocols, reports, and peer-reviewed external journal articles; presenting scientific findings at scientific conferences
• Staying up to date in current developments in the plasmid manufacturing field
• Maintaining digital laboratory notebooks with proper documentation

You will need to have:

Qualifications / Training & Education

• Bachelor’s degree in biology, or a relevant field with 3-4yrs experience or Master’s degree with 2-3yrs experience
• Strong understanding of Good Laboratory Practices for bioprocessing, manufacturing & analytics

Knowledge & Experience

• Strong track record of building successful relationships with supervisors, peers, suppliers, customers, partners and stakeholders
• Excellent communication skills and ability to work well with multiple individuals.
• Ability to work on several projects simultaneously and to switch focus as needed
• Aptitude in keeping accurate and organized records

Technical Competencies

• A solid understanding of bioprocess engineering principles, including knowledge of biochemistry, microbiology, and chemical engineering fundamentals as they apply to bioprocessing.
• Proficiency in designing, operating, and optimizing fermentation systems, including knowledge of different types of fermenters, bioreactors, and associated equipment.
• Expertise in monitoring and controlling fermentation parameters such as pH, temperature, dissolved oxygen, and agitation to optimize microbial growth and product formation.
• Understanding of downstream processing techniques for the recovery and purification of fermentation products, including filtration, chromatography, and separation methods.
• Technical proficiency with laboratory automation and high throughput technologies: such as AKTA Avant, AMBR250, etc.
• Robust molecular/microbiology skills.
• Expertise in aseptic technique.
• Track record of prioritizing multiple, complex, high priority tasks and ensuring timely delivery to meet project needs
• A strong attention to detail and exceptional organizational skills
• Working knowledge of Microsoft Office products, especially with Microsoft Excel.
• The duties of this role are generally conducted in an lab environment.  As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift 15 pounds unassisted; work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown/degown PPE; use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

We would prefer for you to have:

• Proven track record and expertise with plasmid manufacturing and troubleshooting (upstream & downstream)
• Knowledge and the use of statistical analysis, multivariate data analysis and DOE.
• Demonstration of expertise in bacterial fermentation and DNA purification technologies
• Experience with molecular analytical assays related to bacteria and DNA
• Experience in technology transfer from research and development to large-scale production facilities, including the successful implementation of scale-up processes.
• Experience with packing, cleaning and testing chromatography columns

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.