Contract Analytical Chemist (Small Molecule/Drug Development and Manufacturing) - RTP Pharma/Top $$

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

Our client, an RTP area pharmaceutical company with multiple products on the market and multiple products in development, is actively recruiting for a knowledgeable and capable Analytical Chemist to join its Manufacturing Analytical team. 

This position will begin as a contract (6-12 months) with potential for extension.  Company will pay excellent wage to attract and retain an excellent candidate.

Key Things to Note:

  • This company is developing a portfolio of sterile products and is one of the fastest-growing companies in the Triangle. It is a cGMP-compliant operation and related industry experience is required.
  • This position supports small molecule products in all stages of the development process. 
  • This is a lab-based role.  Most work will be performed on site and strict safety measures are being enforced.
  • Role will involve executing experiments towards the development and validation of analytical methods, generating data for process understanding and the establishment of specifications
  • Experience with HPLC, GC, GC-with headspace, Karl Fischer, UV, IR, pH, TLC, particle size testing, and other physical testing will be essential
  • The company uses Empower software, experience with Empower will be important.

Selected Duties:

  • Perform analytical chemistry to develop and validate analytical methodology, mainly stability-indicating HPLC methods, for new drug substances or drug products.
  • Perform and verify compendia methods when appropriate.
  • Generate analytical data for new and existing methods to trouble-shoot issues.
  • Design and execute method validation protocols (including forced degradation studies).
  • Execute stability studies to support the development of new drug substances or drug products.
  • Assist in laboratory investigations for aberrant and out-of-specification data
  • May author technical documents such as, stability reports, and certificates of analysis
  • Conduct work in compliance with cGMP, safety, and regulatory requirements

Targeted candidate will offer a scientific degree (advanced degree preferred) and 5+ years of experience performing analytical testing and method development in industry.  Knowledge of cGMP standards is expected.

Other priorities include:

  • Strong laboratory skills in analytical testing for small molecules; Drug Development and Manufacturing experience is preferred
  • Substantial experience with HPLC
  • Familiarity with GC, GC-with headspace, Karl Fischer, UV, IR, pH, and particle size testing
  • Empower software experience
  • Excellent documentation skills
  • Collaborative, congenial work style combined with ability to work independently, once trained

Finally, we seek a candidate who will thrive in this fast-paced, highly dynamic setting.  A lot is happening.  We seek a flexible and versatile candidate who is ready and able to contribute broadly.

Please forward resume for prompt consideration. Local candidates only.