Senior Scientist II R&D
Danaher Corporation
Summary
Senior Scientist II, Analytical Method Development (AMD), is part of the R&D department located in Fargo, ND and will be on-site. This role will be a part of the AMD team and report to the Director, Analytical Development, be responsible for a small team focused on DNA, mRNA and lipid nanoparticle (LNP) analytics. A significant aspect of this role will include communication between the analytical teams (development, qualification and QC) and clients, facilitating all parties' expectations.
Job description
In this role, you will have the opportunity to:
- Lead a team focused on the design and development of new services and technologies such as (not limited to) mRNA, sgRNA, and LNPs. Develop solutions for simple and complex problems requiring a high degree of ingenuity, creativity, and innovation.
- Lead the execution of experiments for bio-physical and chemical data analysis. Broaden existing knowledge in own field and expand capabilities to other areas relevant to team operations.
- Establish new site processes including preparation of a laboratory, installation/qualification of equipment, development of SOPs, provide technical review of analytical documents to support regulatory filings for our clients, etc.
- Create detailed project reports and present findings and recommendations to both clients and senior management.
- Liaise between clients and analytical teams to facilitate the efficient transfer of knowledge from Aldevron to the client, and from client to analytical teams.
The essential requirements of the job include:
- PhD in biotechnology, biochemistry, or related discipline with 5+ years of industry experience, MS with 7+ years of industry experience, or BS with 10+ years of experience in related industry. CDMO experience is preferred but not required.
- Experience in development and optimization (biologics), assay optimization, experimental design, data analysis, and concept presentation.
- Mastery of regulatory guidelines (compendial and non-compendial) related to phase-appropriate analytical method development and validation.
- Bio-analytical method development skills, including chromatographic or electrophoretic based separation methods, and biophysical / chemical characterization of biologics.
- Excellent communication skills and demonstrate the ability to organize presentations (e.g., PowerPoint), summarize findings, and troubleshoot issues during meetings with clients.
It would be a plus if you also possess previous experience in:
- Analytical method Validation/qualification and/or analytical method comparability
- Analytical methods using Surface plasmon resonance or characterization using a4F-MALs
- Experience in discussing, defending, or authoring analytical topics with/for auditors or regulators
Requirements
- PhD in biotechnology, biochemistry, or related discipline with 5+ years of industry experience, MS with 7+ years of industry experience, or BS with 10+ years of experience in related industry
- Experience in development and optimization (biologics), assay optimization, experimental design, data analysis, and concept presentation
- Mastery of regulatory guidelines (compendial and non-compendial) related to phase-appropriate analytical method development and validation
- Bio-analytical method development skills, including chromatographic or electrophoretic based separation methods, and biophysical / chemical characterization of biologics
- Excellent communication skills and ability to organize presentations, summarize findings, and troubleshoot issues during client meetings
Benefits
- Health care program
- Paid time off
Company overview
Danaher Corporation is a leading global science and technology innovator headquartered in Washington, D.C., specializing in biotechnology, life sciences, and diagnostics. Founded in 1984 by brothers Steven and Mitchell Rales, the company has evolved from its origins as a manufacturing conglomerate into a premier healthcare technology organization with approximately 63,000 employees worldwide. Danaher operates through three core divisions: biotechnology (28% of revenues), which develops products for therapeutic development; life sciences (31% of revenues), focused on disease identification, new therapies, and drug testing/manufacturing; and diagnostics (41% of revenues), providing instruments, consumables, and software for disease diagnosis. The company's portfolio includes renowned brands such as Beckman Coulter, Cytiva, Pall Corporation, Cepheid, Leica Microsystems, and Abcam, serving pharmaceutical companies, biotechnology firms, healthcare providers, and research institutions globally. Danaher is distinguished by its Danaher Business System (DBS), a continuous improvement methodology that drives innovation and operational excellence. With 2024 revenues of $23.9 billion, the company ranks 180th on the Fortune 500 and plays a critical role in advancing scientific research, improving diagnostic capabilities, and accelerating the development of life-saving therapies.