Analytical Scientist (HPLC/Method Development) – Direct Hire – Raleigh Area CDMO

Job Type: 
Other Life Science Positions
Life Sciences
Employment Category: 
Direct Hire

Our client, a leading provider of contract development services for the pharmaceutical industry, is actively recruiting for an exceedingly sharp and knowledgeable Analytical Scientist to join its client services team. Position will involve designing, validating and optimizing HPLC methods, and company will pay industry-leading wage to attract and retain a top-notch candidate.

Key Things to Note:

  • This Analytical Scientist will take methods developed by the R&D group and optimize and validate them for method transfer to the manufacturing facility.  GMP experience would be a plus.
  • Role will also involve developing new methods for APIs, client-created protocols, etc.  Extensive experience with method development will be essential.
  • As a CDO/CDMO, this Scientist will be exposed to a wide range of projects and products.  Further, this Scientist will be actively involved in Peer Review of colleagues’ work. Right candidate will have substantial technical exposure and will bring insight and savvy to the role.
  • This regulated environment will require clean/compliant documentation.  Seek candidate who will bring discipline and regulatory knowledge to the documentation function.
  • This position is on-site at the company’s RTP area labs.

Selected Responsibilities:

  • Develop, enhance, and validate HPLC methods and to manage regulated GLP bioanalysis.
  • Perform chromatographic analyses to support formulation development and bioanalytical activities such as cleaning validation, method optimization, method transfer, stability studies and regulated sample analysis.
  • Show proficiency in U/HPLC use, troubleshooting and maintenance.
  • Validate analytical methods according to the appropriate regulatory guidance.
  • Maintain accurate records and documentation, compliant with GMP, USP and ICH guidelines.
  • Perform analytical tests on AP actives with techniques such as titration, particle size analysis, HPLC and ICP.
  • Generate technical reports and collaborate with QC for validation and assay transfer.
  • Participate in peer review of analytical methods.
  • Demonstrate expertise in chemistry and assist in product and process troubleshooting.
  • Maintain laboratory instruments to ensure proper working order and troubleshoot malfunctions when needed.

Targeted candidate will offer a Bachelor’s degree in chemistry, biology, etc. and 5+ years of experience with analytical testing in a small molecule pharma/biotech setting. Industry experience is required.

Other priorities include:

  • Extensive experience with HPLC techniques and analysis
  • Substantial bkgd in method development, validation and optimization
  • Strong technical troubleshooting and problem-solving skills
  • Meticulous documentation skills
  • Experience with peer review would be a plus
  • Experience in a GMP setting would be a plus

Finally, we seek a congenial and can-do team player will thrive in this growing, empowered and collaborative setting.  A lot is happening and the future is very bright.

This is a Direct Hire role and an immediate need.  Please forward resume or CV for prompt consideration.