Analytical Manager

Location:

RTP North Carolina

Satsuma Pharmaceuticals:

Satsuma Pharmaceuticals is a clinical-stage biopharmaceutical company developing a novel therapeutic for the acute treatment of migraine.  Our lead drug candidate, STS101, is a drug-device combination of a proprietary dry-powder formulation of dihydroergotamine mesylate, or DHE, capable of being quickly and easily self-administered by a proprietary pre-filled, single-use, nasal delivery device.  STS101 is currently being evaluated in a Phase 3 clinical trial.

Job overview:

Reporting to the Analytical Lead, the Analytical Manager will work with external analytical testing labs (including those at contract manufacturing organizations) to oversee routine and non-routine analytical testing associated with the drug-device combination product(s) being developed by Satsuma.  In addition, the Analytical Manager will compile data, perform trend analyses, and make conclusions and recommendations based on analyses.

Duties and responsibilities:

  • Responsible for day-to-day management of analytical activities at established CROs.
  • Responsible for managing all logistics related to analytical testing of R&D, non-clinical and clinical supplies.
  • Proactively identify and address issues that arise during routine analytical testing.
  • Responsible for compiling and performing trend analyses of data as well as presenting data and results to support product development decisions.
  • Create and review documentation, including investigations, change controls, analytical test methods, and study protocols.

Behaviors / skills:

  • Ability to effectively collaborate across all functions of the business so as to ensure consistent and timely achievement of program deliverables.
  • Excellent communication skills, with an ability to work in cross-functional teams including across multiple sites.
  • Excellent planning and prioritization, with the ability to multitask and adapt.
  • Takes accountability for actions, drives results, learns from mistakes; is direct and truthful and therefore widely trusted; deliver on promises, goals and expectations.
  • Self-motivated, with the ability to plan own work.
  • Strong quality orientation with keen attention to detail.
  • Makes quality decisions and resolves problems rapidly.
  • Demonstrated ability to influence across different cultures.

Education & experience

  • Bachelor’s degree in analytical chemistry or similar discipline.
  • Minimum of 7 years’ experience in pharmaceutical industry in an analytical method development and/or analytical testing role.
  • Minimum of 2 years working with or managing contract testing laboratories desired.
  • Direct experience conducting or managing ICH stability programs required.
  • Experience compiling stability data using LIMS and authoring analytical sections for regulatory submissions desired.

For additional information:

Please send your resume or CV to us at careers@satsumarx.com