Associate Principal Scientist

this opportunity • Milford, MA

5h

About The Position

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.

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
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees