Scientist I, RNA at Aldevron in Fargo, North Dakota

Job Description:

At Aldevron, we shape the future of medicine by advancing science in meaningful ways. Our team of dedicated, forward-thinking associates share this goal by combining best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide. We believe people are our most valuable asset. Whether this is your first step on a rewarding career path or are a seasoned professional ready to take your career to the next level, we hire the best from all backgrounds and experiences.

Aldevron is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.

The Scientist I at Aldevron focuses specifically on the RNA manufacturing process and acts as the RNA Operational Lead for all technology transfer activities, both internal and external, to GMP manufacturing in support of RNA Drug Substance Manufacturing. The candidate is expected to be motivated and capable of efficient prioritization, planning and scheduling multiple projects to effectively meet pre-determined deadlines and follow standard work workflows for each activity. The candidate should have experience with manufacturing and scale up in a regulated (ex. cGMP) environment.

This position
is part of the Technical Operations Department located in Fargo, ND and will on-site. At Aldevron, we combine best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide. You will be a part of the RNA Technical Operations team and report to Kate Slama, responsible for technology transfer activities and ensuring smooth transitions to GMP.

In this role, you will have the opportunity to:

• Show thorough understanding and working knowledge of the manufacturing process, technologies, and systems that are utilized to scale up processes within the clinical lab spaces.


• Act as technical SME in the design and execution of SOWs, DOEs, and/or studies with oversight and guidance, lead and oversee execution of edits and updates records from established templates, and participate in peer review.


• Facilitate and lead onboarding of RNA technology transfers, draft comprehensive Master Batch Records, Manufacturing Summary Reports, and process analytical testing plans, and review/update project specific bill of materials in relation to current projects.


• Review technical transfer and process description documents in determining feasibility and scalability of incoming production unit operations.


• Provide technical SME support during manufacturing events and participate in client-facing meetings, providing high-level knowledge and updates.

The essential requirements of the job include:

• 
  Bachelor's degree in biology, microbiology, biochemistry, chemistry, or a related scientific discipline, with 2+ years of experience in process development, engineering, validation, and/or RNA/LNP manufacturing ​OR Master's degree in biology, microbiology, biochemistry, chemistry, or a related scientific discipline.


• Knowledge of GMP's and regulatory requirements for biologics manufacturing.


• Ability to balance changing priorities tasks along with strong critical and logical thinking to analyze problems.


• Communicate effectively with cross-functional teams, including Technical Operations, Technical Writing, Manufacturing, R&D, Quality, and Regulatory.

Travel & Physical/Environment Requirements:

• This position requires up to 10% travel.


• This position operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.


• While performing the duties of this position, the employee is regularly required to see, talk and hear. The employee frequently is required to stand, walk, bend, lift up to 50 pounds, and use arms, hands and fingers for various activities. This position may stand or remain sedentary for long periods of time. This position routinely works with large pieces of equipment.

It would be a plus if you also possess previous experience in:

• Manufacturing experience at a CDMO, with basic understanding of upstream and downstream bioprocessing.


• Regulatory understanding of and experience working within cGMP environments.

Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit

www.danaher.com
.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

The EEO posters are available here.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation.