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Analytical Development Principal Scientist (218)

Employer
Nitto Avecia Pharma Services
Location
Malborough, Massachusetts, United States
Start date
Jun 8, 2019

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Discipline
Information Technology, Business/Data Analytics, Science/R&D, Biotechnology
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Genetown
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Job Details

Equal Opportunity Employer

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


Job Knowledge Required:
  • BA/BS/MS with 15+ yrs. of related experience
  • 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

Company

With over 25 years of experience in oligonucleotide development and production, and over 1000 sequences manufactured, Avecia has played an integral role in the advancing oligo therapeutic market. Our mission is to continue to build value for our customers, as they progress through drug development into commercialization. And as a member of the Nitto Denko Corporation (www.nitto.com), Avecia is committed to the future of the oligonucleotide market. We are driven by innovative ideas and flexible solutions, designed to provide our customers with the best in service, quality, and technology.

Additional locations:

33 Locke Drive
Marlborough, MA 01752
 
8560 Reading Road
Cincinnati, OH 45215
Tel: (513) 679-3000

Company info
Website
Mini-site
Nitto Avecia Pharma Services
Phone
+1-949-951-4425
Location
10 Vanderbilt
 Irvine
CA
92618-2010
US
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