Analytical Chemist (Pharma Manufacturing/HPLC) – Direct Hire – RTP, NC

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

Our client, a specialty pharmaceutical firm in the RTP area, is actively recruiting for a skilled and knowledgeable Analytical Scientist to assume a key role on its Analytical Chemistry Manufacturing team.

This company has a growing portfolio of ophthalmological products with a rich and expanding pipeline.  The primary focus for this Analytical Chemist is to perform method validation and stability testing on drug substance and other starting materials. 

This is a critical role and the Company will offer a generous compensation package, to include relocation, to attract and retain a quality candidate.

Key Things to Note:

  • This is a lab-based position supporting small molecule drug development and manufacturing programs.  Seek candidate open to full-time on-site role.
  • The Analytical Chemist will   be responsible for analytical testing in support of activities focused on method development and validation, method transfer, sample analysis, stability, as well as investigative studies for troubleshooting.
  • Techniques include HPLC, GC, GC-with headspace as well as LC Mass Spectroscopy and Mass Spectroscopy and other physical testing. Related exposure will be important.
  • This is an emerging business setting in which processes and procedures are being developed and enhanced.  Seek candidate who will contribute ideas and insights to developing SOPs.

Specific responsibilities will include:

·Performing analytical chemistry independently or in collaboration with others to develop and validate analytical methodology, mainly stability-indicating HPLC methods, for new drug substances

·Performing and verifying compendia methods

·Generating and interpreting spectroscopic analytical data related to the structural identification of reference standards or impurities

·Drafting and executing method validation protocols and reports

·Executing stability studies to support the development of new drug substances

·Designing or assisting laboratory investigations for aberrant and out-of-specification data

·Authoring technical documents such as method development reports, stability reports, and certificates of analysis

·Maintaining laboratory records and provide peer review and approval of quality critical data

  • Supporting authoring and/or reviewing standard operating procedures pertaining to analytical testing and reporting
  • Executing investigational studies independently or in collaboration with others to address specific issues

All work is performed in a GMP compliant lab and conducted in compliance with cGMP, safety, and regulatory requirements.  We seek a candidate from industry with an understanding of related standards and practices.  Targeted candidate will offer a Chemistry, or related scientific, Degree (advance degree preferred) and 5 years of directly related analytical chemistry experience in an industry setting.  

Experience with the following techniques, instrumentation and software tools will be important:

  • HPLC, GC, GC-with headspace is required.  Experience with LC Mass Spectroscopy and Mass Spectroscopy interpretation is strongly preferred
  • Experience with FT-IR, NMR, Karl Fischer, UV, IR, pH, TLC, particle size testing, and other physical testing is also preferred.
  • Solid laboratory skills in analytical method development and testing of small molecules
  • Organic chemistry background preferred.
  • The individual should be comfortable working in a fast-paced environment – able to rapidly flex activities and priorities.

We seek a team player, a goal-oriented individual with excellent communication and organization skills.  Finally and critically we seek a candidate who will thrive in a fast paced and highly dynamic setting. 

Please forward Word resume for prompt consideration.  Local candidates only.