Scientist, Medical Technologist & Lab Technician

Job Title:

Scientist

Quality Control

On‑Site, Durham Location

Pelthos Therapeutics is a bio‑pharmaceutical company committed to commercializing innovative, safe and efficacious therapeutic products to help patients with unmet treatment burdens. For more information, please visit our website at  or follow us on Linked In and X.

The Scientist will be responsible for testing and reporting data for reference standards, drug substance intermediates, drug substance, drug product and raw material packaging components.

• Independently perform R&D and/or GxP analytical testing of drug substance intermediates, drug substances, drug product, raw materials and packaging components
• Perform method development/validation for intermediates, drug substance and drug product with minimal oversight from management
• Adherent to scheduled lab activities to ensure on‑time delivery of technical deliverables
• Author laboratory notebook write‑ups, data packets and reports for internally generated data while adhering to GxP requirements
• Author and/or review analytical procedures, validation documents, SOP’s and Quality documents such as lab investigations or deviations
• Ensure internal review of assigned work is completed within 30‑day turnaround time
• Perform data review activities, as needed
• Serve as equipment SME and perform training, as needed
• Proactively identify and troubleshoot challenges in the lab and elevate to management when required
• Lead problem‑solving efforts for lab investigations/deviations, instrument troubleshooting and empower operational challenges
• Ensure compliance and adherence to lab related SOPs and drive process improvement efforts
• Manage routine lab operations including glassware cleaning, performing chemical and sample inventories, and ordering supplies
• Organize data sets and communicate results to management, escalating atypical results to management
• Understand and follow GxP practices when appropriate and adhere to Pelthos’ Quality Systems in all work performed, including but not limited to, good laboratory documentation practices
• Properly manage hazardous waste in their area where hazardous waste is generated and/or accumulated
• Perform other duties as assigned

• BS or MS in chemistry, or related discipline
• 4+ years of related experience

• Practical experience in all or some of the following instrumentations and techniques are required:
  • Gas chromatography
  • High performance liquid chromatography
  • pH meter
  • Basic wet chemistry
  • Coulometric Karl Fischer titrations
• Practical experience in the following instrumentations and techniques is desirable:
  • Ion chromatography
  • Fourier Transform Infrared Spectroscopy
  • Ultraviolet to visible spectroscopy
  • ICP‑MS/ICP‑OES
  • Viscometer
  • Particle size analyzers
  • Nitric oxide detection
• Practical experience with Empower is required
• Use of statistical software such as JMP is desirable

The essential functions of this position include:

• Lift up to 10 lbs on a frequent basis
• Lift 25‑50 lbs on an occasional basis
• Stand, walk and sit for prolonged periods of time on a frequent basis
• Climb, balance, stoop, kneel, crouch or crawl on an occasional basis
• Reach, using hands and arms on a frequent basis
• Use hands to feel on an occasional basis
• Communicate using hearing and speech on a frequent basis (in‑person and/or virtual)
• Use sense of smell and vision (color difference, depth perception) on an occasional basis
• Up to 10% of travel (as needed)