Senior Scientist II R&D

Danaher Corporation•Fargo, ND

1d•Onsite

About The Position

The Senior Scientist II, Analytical Method Development (AMD), is part of Aldevron’s R&D department in Fargo, North Dakota, and works on-site. The role reports to the Director, Analytical Development and leads a small team focused on analytics for DNA, mRNA, and lipid nanoparticles (LNPs). It also coordinates communication among analytical development, qualification, and QC teams and clients, helping align expectations and facilitate knowledge transfer. The position leads the design and development of new services and technologies, including work involving mRNA, sgRNA, and LNPs, and leads experiments for biophysical and chemical data analysis. It establishes new site processes, including laboratory preparation, equipment installation and qualification, and SOP development. The role also provides technical review of analytical documents supporting client regulatory filings, creates project reports, presents findings and recommendations to clients and senior management, and prioritizes, plans, and schedules multiple projects to meet deadlines.

Requirements

PhD in biotechnology, biochemistry, or a related discipline with 5 or more years of industry experience; or a master’s degree with 7 or more years of industry experience; or a bachelor’s degree with 10 or more years of related-industry experience.
Experience in biologics development and optimization, assay optimization, experimental design, data analysis, and presenting concepts.
Mastery of compendial and non-compendial regulatory guidelines related to phase-appropriate analytical method development and validation.
Bioanalytical method development skills, including chromatographic or electrophoretic separation methods and biophysical or chemical characterization of biologics.
Excellent communication skills, including the ability to organize presentations, summarize findings, and troubleshoot issues in client meetings.

Nice To Haves

CDMO experience.
Experience with analytical method validation or qualification and/or analytical method comparability.
Experience with analytical methods using surface plasmon resonance or characterization using a4F-MALS.
Experience discussing, defending, or authoring analytical topics with or for auditors or regulators.

Responsibilities

Lead a team focused on designing and developing new services and technologies, including mRNA, sgRNA, and LNPs.
Develop solutions for simple and complex problems requiring ingenuity, creativity, and innovation.
Lead experiments for biophysical and chemical data analysis and expand the team’s capabilities into relevant areas.
Establish new site processes, including preparing a laboratory, installing and qualifying equipment, and developing SOPs.
Provide technical review of analytical documents supporting client regulatory filings.
Create detailed project reports and present findings and recommendations to clients and senior management.
Liaise between clients and analytical teams to facilitate knowledge transfer in both directions.
Prioritize, plan, and schedule multiple projects to meet predetermined deadlines.