Aldevron
Senior Scientist I R&D
Aldevron, Fargo, North Dakota, us, 58126
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 you 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.
At Aldevron, you will be a part of the Analytical Method Development (AMD) team and report to the Principal Scientist responsible for development and optimization of analytical methods that will be used for investigative testing, GMP release testing, and stability testing of Aldevron Products (e.g., nucleic acids, lipid nanoparticles).
In this role, you will have the opportunity to:
Independently propose, lead, and oversee the development of analytical methods such as dPCR, CGE, spectrophotometry, ELISA, and HPLC in the laboratory and through collaboration with internal and external stakeholders. Ensure that methods are robust and fit-for-purpose as release tests for GMP Quality Control.
Provide input into or create project timelines, provide updates to management, and adhere to those timelines.
Provide technical support for activities associated with method validations and transfers, including the development of validation strategies to meet regulatory requirements. This includes creating, revising, and finalizing standard operating procedures (SOPs), study protocols, study reports, product specifications, and other GMP documents.
Serve as a subject matter expert to junior scientific staff regarding enhanced approaches to analytical procedure development and lifecycle management. This includes generating control strategies for new analytics, proposing purposeful experiments to guide method development, and providing recommendations to optimize procedures for subsequent validation.
Identify and implement new techniques and instrumentation to expand internal capabilities. Prepare justifications for capital expenditures (e.g., new laboratory instruments). Prepare purchase orders and coordinate authorization, procurement, and implementation.
The essential requirements of the job include:
Ph.D. in Biology, Molecular Biology, Chemistry, Biochemistry, Analytical Chemistry, or a related scientific field with a minimum of 3 years of relevant industry experience; or a Master’s degree with a minimum of 5 years of relevant industry experience; or a Bachelor’s degree with a minimum of 8 years of relevant industry experience. Relevant experience includes working in assay development and/or validation, optimization, experimental design, and data analysis in a regulated industry (cGMP).
Ability to independently propose and lead analytical method development projects with purposeful experimental design and anticipate results that drive towards the conclusions necessary for successful assay development. A successful track record of analytical method development that leads to method validation.
Excellent troubleshooting ability to support both analytical development work and Quality Control OOS/OOT investigations as a subject matter expert.
Ability to develop solutions for simple and complex problems, requiring a high degree of ingenuity, creativity, and innovation.
Strong understanding of regulatory guidelines, such as ICH (e.g., Q2(R2) and Q14), FDA, EMA, or compendia.
It would be a plus if you also possess previous experience in:
Working directly with DNA, RNA, and/or lipid nanoparticles.
Leading scientific teams.
#J-18808-Ljbffr
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.
At Aldevron, you will be a part of the Analytical Method Development (AMD) team and report to the Principal Scientist responsible for development and optimization of analytical methods that will be used for investigative testing, GMP release testing, and stability testing of Aldevron Products (e.g., nucleic acids, lipid nanoparticles).
In this role, you will have the opportunity to:
Independently propose, lead, and oversee the development of analytical methods such as dPCR, CGE, spectrophotometry, ELISA, and HPLC in the laboratory and through collaboration with internal and external stakeholders. Ensure that methods are robust and fit-for-purpose as release tests for GMP Quality Control.
Provide input into or create project timelines, provide updates to management, and adhere to those timelines.
Provide technical support for activities associated with method validations and transfers, including the development of validation strategies to meet regulatory requirements. This includes creating, revising, and finalizing standard operating procedures (SOPs), study protocols, study reports, product specifications, and other GMP documents.
Serve as a subject matter expert to junior scientific staff regarding enhanced approaches to analytical procedure development and lifecycle management. This includes generating control strategies for new analytics, proposing purposeful experiments to guide method development, and providing recommendations to optimize procedures for subsequent validation.
Identify and implement new techniques and instrumentation to expand internal capabilities. Prepare justifications for capital expenditures (e.g., new laboratory instruments). Prepare purchase orders and coordinate authorization, procurement, and implementation.
The essential requirements of the job include:
Ph.D. in Biology, Molecular Biology, Chemistry, Biochemistry, Analytical Chemistry, or a related scientific field with a minimum of 3 years of relevant industry experience; or a Master’s degree with a minimum of 5 years of relevant industry experience; or a Bachelor’s degree with a minimum of 8 years of relevant industry experience. Relevant experience includes working in assay development and/or validation, optimization, experimental design, and data analysis in a regulated industry (cGMP).
Ability to independently propose and lead analytical method development projects with purposeful experimental design and anticipate results that drive towards the conclusions necessary for successful assay development. A successful track record of analytical method development that leads to method validation.
Excellent troubleshooting ability to support both analytical development work and Quality Control OOS/OOT investigations as a subject matter expert.
Ability to develop solutions for simple and complex problems, requiring a high degree of ingenuity, creativity, and innovation.
Strong understanding of regulatory guidelines, such as ICH (e.g., Q2(R2) and Q14), FDA, EMA, or compendia.
It would be a plus if you also possess previous experience in:
Working directly with DNA, RNA, and/or lipid nanoparticles.
Leading scientific teams.
#J-18808-Ljbffr