Associate Principal Scientist

About this opportunity :

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

Key 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.

Required Skills/Abilities: 

• 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. 

The annualized salary range for this position is $140,800.00 - $172,200.00.