Associate Principal Scientist

Nitto Denko Corp. • Milford, MA

2d

About The Position

The Associate Principal Scientist is responsible for meeting the analytical testing requirements to support research and development projects primarily focused on oligonucleotides.

Requirements

• BA/BS with 12+ yrs. of related experience.
• MS with 9+ yrs. of related experience.
• PhD with 6+ yrs. of related experience.
• Subject matter expert analytical chemistry knowledge including theory and application of two or more chromatographic and spectroscopic techniques for identification, purity, and assay of various analytes.
• Operate and troubleshoot available instruments including HPLC and MS.
• Review and approve outsourced method development and validation.
• Application of chemistry and oligonucleotide knowledge to method development and solving complex problems independently.
• Advanced Word, Excel and PowerPoint.
• Perform advanced algebraic and statistical calculations correctly.
• Proficient in technical writing and presentations to internal and external audiences.
• Author, revise, and approve laboratory and systemic SOPs.
• Competency to think strategically and conceptually to apply quality by design principles when designing experiments.
• Perform method gap and error analyses.
• Knowledge and application of cGMPs and regulatory guidance documents.
• Knowledge of Oligonucleotide chemical and physical properties.
• Current methods to characterize oligonucleotides.
• Remain abreast of emerging analytical technologies in the oligonucleotide field.

Responsibilities

• Supervise/manage staff as needed.
• Design and/or execute testing per method or protocol for development, qualification, verification, validation, and transfer of analytical methods for multiple projects.
• Analyze and review project data, correct errors, and report results for multiple projects to support research and development primarily focused on oligonucleotides.
• Perform GDP, technical, and gap analysis review and investigations across multiple projects.
• Author and approve scientific and regulatory documentation.
• Provide professional scientific leadership in all internal and external interactions.
• Improve laboratory compliance.
• Design, review, perform, and improve method development experiments and strategies.
• Propose, develop and implement new analytical applications and technology.
• Provide advanced-level training internally and externally.
• Plan, track, execute, and review multiple project team tasks to deliver project results on time.
• Exercise independent judgment in developing methods, techniques, and evaluation criteria for obtaining results.
• Communicate with clients and resolve issues in consultation with laboratory management.
• Interview candidates and advise management on hiring.
• Develop and lead implementation of department objectives for continuous improvement and technical excellence.
• Advise clients on analytical scope to meet technical and regulatory requirements.
• Review BD customer proposals.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees