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 $140800.00 - $172200.00.
Required Experience:
Staff IC
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...
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 $140800.00 - $172200.00.
Required Experience:
Staff IC
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