Analytical Scientist (HPLC/RP/High Throughput) - R&D Mftg/Emerging Pharma

Category: 
Life Sciences
Job Type: 
Life Sciences
Clinical Research and Development
Scientific Research and Lab Operations
Employment Category: 
Direct Hire

Analytical Scientist (HPLC/RP/High Throughput) - R&D Mftg/Emerging Pharma

Our client, a rapidly-expanding RTP-based pharmaceutical company that is developing a portfolio of ophthalmic products, is actively recruiting for a skilled, savvy and self-directed Analytical Chemist, to assume key role on its team. 

This company recently received FDA approval on one of its products and has a rich pipeline of other products in various stages of development.  This is an outstanding foot-in-the-door opportunity for a high potential candidate.

Key Things to Note:

  • This role will begin in the company’s polymer-based implants division.  Related exposure would be valuable.
  • This scientist will be focused on the analytical testing of research, in-process, and finished product samples.  Experience with HPLC and High Throughput Testing will be needed.
  • Most of the analytical work will be R&D manufacturing, not QC.  Seek innovative and insightful scientist with substantial experience in method development.
  • All work is conducted in compliance with cGMP, safety, and regulatory requirements.  Seek candidate from industry with understanding of related standards and practices.
  • This role will involve substantial interface with numerous stakeholders.  We seek a collaborator.

Position will involve providing analytical support to the company’s R&D manufacturing programs including analysis and characterization of raw materials, formulation and process development support, and implant formulations.

Specific Responsibilities:

  • Independently perform analytical testing of finished product samples
  • Analyze intra-ocular implants for content, purity, and dissolution profile by HPLC in a research-to-Phase 3 environment
  • Develop and optimize HPLC and GC methods for analysis of novel compounds in intra-ocular implants (may use Reverse Phase, Size Exclusion, or Ion Exchange Chromatography)
  • Characterize biodegradable implants by DSC, DHR, and microscopy
  • Manage sample throughput and quality
  • Apply scientific methods and observational and critical analysis skills to execute experiments, analyze data, and draw conclusions from results
  • Maintain high-throughput volume of routine testing

Ideal candidate will offer a Chemistry degree and 4+ years of increasingly responsible roles in analytical chemistry in GMP compliant labs.  Exposure to functions noted above will be important.  Other priorities include:

  • Proficiency with HPLC and common chromatography data systems
  • Strong method development skills utilizing HPLC in multiple separation modes (RP, HILIC)
  • Familiarity with common USP dissolution techniques and methodologies
  • Polymer characterization experience would be a plus
  • Proficiency with common chromatographic partitioning techniques (RP, SEC, IEX)
  • Meticulous documentation habits
  • Longevity and impact in previous roles

Finally and critically, we seek a candidate who will thrive in this growing and fast paced setting.  A process improvement-focused candidate who enjoys helping to develop the blueprint for a growing operation.  The future is very bright.  We seek a candidate who will contribute and thrive.