Quality Control Chemist
Summit Biosciences Inc. - Lexington, KY

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Responsible for performing a wide variety of hands-on analytical work to support the successful development and commercialization of pharmaceutical nasal spray drug products.

Essential Duties:

  • Conduct testing of raw materials and components, in-process and finished product samples per standard operating procedures.
  • Perform peer review of documentation for accuracy, compliance to SOPs and completeness.
  • Lead stability sample coordination and testing work for multiple drug products
  • Lead analytical projects or participate on teams to develop and commercialize products.
  • Assist with the performance of formulation development studies and the transfer of analytical methods from outside sites.
  • Write technical reports related to assigned work.
  • Coordination with Materials Management for procuring excipients, drug substances and components for coordination and completion of the testing.
  • Identify and implement methods for cost savings, improved efficiency and control.
  • Assist management with training and guiding of technicians for the execution of sample analysis and protocols.

Candidate Attributes:
The individual must have experience in an FDA regulated cGMP laboratory environment. Additionally, the Chemist possesses:

  • Excellent organizational skills and attention to detail.
  • Strong interpersonal and communication skills and demonstrated ability to effectively communicate with all departments.
  • Motivated to perform work while maintaining a focus on the long-term, continuous improvement of laboratory systems, compliance and training programs.
  • Must be flexible, adaptable, self-motivated and able to work well independently and across teams and partners.
  • Ability to work in a lean, action oriented organization and demonstrate a strong work ethic.
  • Experience testing nasal spray products is a plus.

Minimum Qualifications:

  • BS in Chemistry, Biochemistry or related field
  • 5 years of applicable experience working in a pharmaceutical laboratory
  • Hands on experience with analytical laboratory instrumentation including HPLC
  • In depth knowledge of cGMP regulatory requirements
  • Excellent technical writing and organizational skills
  • Qualified to handle controlled substances
  • Good interpersonal skills and the ability to work well in a team environment