Analytical Development Principal Scientist

Purpose of the Position:

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

Key Job Responsibilities:

• Supervise/manage staff as needed

• Lead the design of testing per method or protocol for development, qualification, verification, validation, and transfer of analytical methods for multiple projects simultaneously

• Analyze and review project data, correct errors, and report results for multiple projects to support research and development primarily focused on oligonucleotides

• Author and approve scientific and regulatory documentation

• Lead and perform GDP, technical, and gap analysis review and investigations across multiple projects

• Provide professional scientific leadership in all internal and external interactions

• Monitor laboratory compliance

• Design, review, and improve method development strategies

• Champion and implement new and innovative 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 latitude in determining objectives and approaches to critical assignments

• Communicate with clients and directly resolve issues

• Interview candidates and advise on hiring, improvement plans, and promotions.

• Develop and lead inter-department objectives for continuous improvement and technical excellence

• Advise clients on analytical scope to meet technical and regulatory requirements

• Review BD customer proposals and represent department in customer-facing meetings

• Mediate personnel conflicts within the group and promote a positive work atmosphere

  Job Knowledge Required:

• BA/BS/MS with 15+ yrs. of related experience or PhD with 10+ yrs. of related experience

• Subject matter expert analytical chemistry knowledge including theory and application of three 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

• Fundamental scientific knowledge of chromatography, spectroscopy, and spectrometry methods

• Advanced Word, Excel and PowerPoint

• Review and correct advanced algebraic and statistical calculations

• Proficient in technical writing and represents Avecia to the oligonucleotide community through technical presentations and publications

• Author, revise, and approve 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

• Application of oligonucleotide chemical and physical property knowledge to develop new methods to characterize oligonucleotides

• Remain abreast of emerging analytical technologies in the oligonucleotide field

Equal Opportunity Employer